job description mfg process technician- bio · instrument technician is responsible for the daily...

Job Description Nov 26, 2015

Mfg Process Technician- Bio

GCF Grade Level: 2 Site: Amgen Singapore Manufacturing (ASM)

Role Description:

Amgen Singapore Manufacturing is looking for energetic staff members to fill manufacturing process technician positions in Amgen’s new Singapore facility. After training is completed this position will be required to work on a rotational overnight shift. Amgen’s state-of-the-art biotechnology manufacturing and process development capabilities help us realize the potential of our pipeline for patients around the world. The new Amgen facility is capable of manufacturing both clinical and commercial products. Provide solution and equipment preparation support, raw material and single use parts dispensing for manufacturing processes in mammalian cell culture and purification processes.

Responsibilities: • Involve in hands-on execution of the plant operations and assist Manufacturing Associates in trouble-shooting • Monitor and analyze processing parameters for atypical trends and improvement opportunities • Perform solution and equipment preparation • Perform raw material and singe use parts staging and dispensing with additional logistical support responsibility • Stage components for autoclaving and washing • Perform filter integrity testing of sterilising filters • Perform environmental monitoring of classified manufacturing cleanroom • Support in-process testing of production samples, prior experience with analytical instrument will be a plus point • Actively support continuous improvement initiatives • Support Safety audits • Adhere to any applicable EHS requirements • Ability to adhere to regulatory requirements, written procedures and safety guidelines • Ability to evaluate documentation/data according to company and regulatory guidelines • Ability to interact with inspectors (internal and external) • Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge • Basic statistical mathematical skills • Ability to organize work and handle multiple priorities and meet deadlines • Ability to understand, apply and evaluate basic chemistry, biology and physical principles • Regulatory knowledge • Understanding of analytical methods

Education / Licenses • Diploma in Science or Engineering.

Competencies / Skills

• NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences or Bio-processing related disciplines • Possess minimum 0 - 2 years of relevant experience in the biotechnology, pharmaceutical or petrochemical industry. Fresh graduates will be considered. • Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem solving skills • Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation • Strong analytical skills with knowledge of Lean and Six Sigma • Excellent self-motivated team player with hands-on attitude and good communication skills • Experience with Emerson DeltaV, LIMS, TrackWise

• Ability to understand, apply and evaluate basic chemistry, biology and physical principles • Ability and willingness to work any shift in support of operations that may include 24/7 • Mechanical ability/expertise


Associate Mfg - Bio


Role Description:

Amgen Singapore Manufacturing is looking for energetic staff members to fill manufacturing associate I positions in Amgen’s new Singapore facility. After training is completed this position will be required to work on a rotational overnight shift. Amgen’s state-of-the-art biotechnology manufacturing and process development capabilities help us realize the potential of our pipeline for patients around the world. The new Amgen facility is capable of manufacturing both clinical and commercial products. Under general supervision, the manufacturing associate will support daily production requirements throughout the facility. Operations, maintenance and analytical testing will be performed according to Standard Operating Procedures (SOPs) and Job Plans, as required. The Associate Manufacturing will perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports. They will perform basic troubleshooting and assist in the review of documentation for assigned functions. The Associate Manufacturing may participate on cross-functional teams, have the responsibility of owning NC/CAPAs, and may identify, recommend and implement improvements related to routine functions. Only candidates who apply via www.amgen.com/careers will be considered. Amgen retains the right to add or change the duties of the position at any time. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace

Education / Licenses • Undergraduate degree or diploma in Science or Engineering.

Competencies / Skills

• Fluency in written and spoken English • 1 year of experience in regulated environment • Experience and basic troubleshooting skills with laboratory and process equipment • Experience with Emerson DeltaV, OSI PI, LIMS, TrackWise • Ability to understand, apply and evaluate basic chemistry, biology and physical principles • Regulatory knowledge • Ability to adhere to regulatory requirements, written procedures and safety guidelines • Ability to evaluate documentation/data according to company and regulatory guidelines • Ability to interact with inspectors (internal and external) • Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge • Basic statistical mathematical skills • Ability to organize work, handle multiple priorities and meet deadlines • Demonstrated written and oral communication skills • Technical writing capabilities • Proficient presentation and facilitation skills • Detail oriented as well as flexible and adaptable to changing priorities and requirements • Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based

Training (CBT) • Mechanical ability/expertise • Understanding of analytical methods • Ability and willingness to work any shift in support of operations that may include 24/7

A

Senior Associate Supply Chain Req #: Career Categories: Supply Chain Location: Singapore – Singapore GCF:4

Amgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

We are seeking a highly motivated individual a Supply Chain role within Supply Chain department of Amgen Manufacturing. The ideal candidate must have a solid experience in one or several core functions within pharmaceutical Operations (Manufacturing, Warehouse Operations, Distribution, and Quality Control). The candidate must also have a good understanding of GMP regulations and possess critical thinking and analytical skills. It is important for this candidate to have excellent verbal and written English skills, as well as a proven ability to effectively partner with and influence cross-functional Teams. It is also essential for the candidate to be a self-starter and be comfortable working in a fast-paced and dynamic environment.

Job Description

This role is within the Supply Chain organization of Amgen Singapore Manufacturing. The key responsibilities include:

1. Supports the different Supply Chain domains on deviation, change control, corrective and preventive action,

effective verification, validation and qualification and documentation, including highly complexed cases that spread across various functions. Works closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP.

2. Support Supply Chain audits, response to regulatory questions and audit findings. 3. Develop and maintain Standard Operation Procedures, user manual, periodic review reports or other form of

documents. 4. Identify improvement opportunities, on the basis of analysis and KPI’s, their impact on performance (benefits vs.

cost) and prioritize associated initiative. 5. Lead cross functional meetings and ensure plans are in place, clearly communicated and implemented.

Lead or participate in Continuous Improvement initiatives using problem solving techniques (Operational Excellence, 6σ, LEAN) to ensure flawless execution of supply chain activities.

6. Provide project management support as necessary in various areas for example procurement, production planning, warehouse & transportation and sampling.

7. Share and adopt best practices across the Global Supply Chain network. 8. Work under minimal supervision in line with Amgen Values and Leadership Attributes.

**Other functions could be assigned as and when appropriate

Basic Qualifications Bachelor's degree or Associate's degree & 2 years of directly related experience or High School diploma/GED & 6 years of directly related experience. OR

Associate’s degree and 6 years of Supply Chain/Business Analyst experience in a GMP and/or Good Distribution Practice regulated industry experience

OR

High school diploma / GED and 8 years of Supply Chain/Business Analyst experience in a GMP and/or Good Distribution Practice regulated industry experience

Preferred Qualifications

• Degree in Engineering, Supply Chain, Biologic & Life Sciences. • Minimum 3 years’ working experience in GMP operations environment. • Good technical knowledge of supply chain operation. • Ability to execute a technical study with minimal guidance. • Ability to organize, analyze and interpret technical data through trend analysis,

forecasting, modeling, etc. • Ability to effectively communicate complex technical information with internal and

external colleagues at different organizational levels in both presentation and written forms.

Amgen Proprietary - For Internal Use Only

Instrument Technician

Job Description :

Instrument Technician is responsible for the daily maintenance works assigned by the maintenance planner. Instrument Technician must be able to perform assigned tasks competently with minimal supervision and communicate to customer effectively to assure minimal impact to production. Instrument Technician ensures that such works are closed in a timely manner with proper documentation, complying with cGMP requirements, Amgen procedures and safety regulations. Key activities:

• Perform instruments calibration in accordance to Amgen SOPs • Carry out repair, installation, troubleshooting of instrument used for manufacturing, utility

plants and analytical labs. • Ensure that calibration documents, instruments files and work order documentation are

completed in a timely manner with accurate information in accordance with CFRs, cGMPs, SOPs, and Amgen policies

• Plan and schedule work activities and coordinate work performed by contractors with manufacturing staff to minimize impact to production activities.

• Ensure maintenance job plans and calibration datasheets are accurate. • Maintain calibration standards in good working condition with valid calibration certificates • Assist in the investigation for instrument related failure analysis; provides effective and

viable corrective and preventive actions. • Assist the team with maintaining an up-to-date working spare parts inventory system for

the equipment/systems that the team is responsible for. • Response to out of office hours call and response to issues related to instrumentation. • Adhere to Amgen Safe work practices and develop Job Hazard Analysis (JHA) related to

instrumentation works.

Required competencies/skills/experience: • Fresh graduates with a diploma or recognized technical certificate from recognized

technical institute in electrical, electronic or mechatronics engineering. • A self-motivated personnel that is able to work with minimal supervision or guidance and

provide pragmatic resolution to overcome challenges in a dynamic environment. • Work in assigned working hour and willing to be scheduled for call-outs during non-office

hours to support manufacturing emergencies • Competency in basic computer skill. • Good interpersonal and communication skill • Fluency in written and spoken English • Availability and willingness to work on rotating shift


Maintenance Technician

Job Description The Maintenance Technician is responsible to perform day to day maintenance activities to support Biologics and API manufacturing operations at Amgen Singapore Manufacturing

Specific duties include:

• Perform hands-on maintenance e.g. overhaul valves, replace filters, replace pump seals, replace fan belts and diaphragm replacement

• Execute maintenance work orders including condition monitoring, failure finding, and corrective maintenance

• Assist in plant testing, commissioning and qualification activities • Trouble shoot equipment safety and reliability issues e.g. participate in root cause analysis

and problem solving • Provide frontline support by performing basic repair and troubleshooting to maintain system

including associated controls and equipment in good condition. • Coordinate with Planner, Utilities, and Manufacturing teams for system shutdown

maintenance by performing Lock out Tag out in accordance to Safe Work Procedures. • Adhere to Amgen Safe work practices and develop Job Hazard Analysis (JHA) related to

Maintenance works • Any other tasks as assigned.

Preferred Qualifications/Competencies:

• Fresh graduates with a diploma or recognized technical certificate from recognized

technical institute in Mechanical Engineering or Mechatronic Engineering • Work in assigned working hour and willing to be scheduled for call-outs during non-office

hours to support manufacturing emergencies • Competency in basic computer skill. • Good interpersonal and communication skill • Fluency in written and spoken English • Availability and willingness to work on rotating shift

FACILITIES ENGINEER (BOOST PROGRAM) The candidate will be responsible in supporting the Facilities Manager, managing the day to day operations which includes managing the vendor service contracts and delivering a high performing facilities and great collaboration with stakeholders. Key Activities: Key equipment/systems may include: Architectural work, building maintenance, clean

room maintenance, fire protection system, security system, painting, docks, grounds, pest control, Staff Amenities, transportation services, janitorial cleaning, cGMP area cleaning, gowning services and etc.

Establishes and operates a customer service feedback mechanism to address and timely resolve concerns raised

Maintains facilities work order relating to routine or non-routine maintenance of facilities building maintenance

Maintains high standards of cleanliness levels as required in various zones in compliance to QA requirements

Coordinates and manages GMP services such as cleaning & pest control service program and follow up closely on any pest incident and investigation

Coordinates schedules for operations, maintenance, and administrative staff on required basis for effective facilities program implementation and required enforcement

Support and owns facilities services related Non Conformance (NC) and Corrective Action and Preventive Action (CAPA)

Manages facility improvement works and supports facilities related cost saving projects Manages all facilities soft services, couriers, stationery, meeting rooms, café, pantry, bus

services, café operations, etc. Supports EHS walkdowns, punchlists and follow up actions. Manages all site activities within the plant, such as festive celebrations, making it a Great

Place to Work Supports and execute Facilities Transformation initiatives and all other non-routine tasks

assigned by Manager

Qualifications / Competencies:

Fresh Grad, Degree in Engineering or Facilities Pleasant personality, Positive and Can-Do Attitude Good interpersonal and communication skills with high computer literacy Fluency in English, in both oral and written communication

LOCAL BIOLOGICS SKILLS TRAINING (BOOST) PROGRAMME ENGINEERING – EQUIPMENT PERFORMANCE & RELIABILITY PROGRAM

Job Posting SUMMARY Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. This role will serve as support engineer in the development and implementation of the equipment performance and reliability program for Amgen Singapore Manufacturing Plant. This will give to the candidate and opportunity to learn about Biotech Process, API Process and Utilities equipment operation and maintenance. Also the opportunity is aligned with most of the core and elective modules highlighted below which will give the candidate a holistic overview the Biologics and Small Molecule Business. Boost Program Modules: Core Modules Follow Good Manufacturing Practices Apply Safety in Process Plant Apply Continuous Process Improvement Techniques Apply Process Quality Control Techniques Perform Emergency Shutdown of Process Plant Elective Modules Operate Inoculation and Fermentation Reactors Apply cGMP Requirements in the Workplace Operate in a Controlled Clean Room Environment Operate Tangential Flow Filtration Process Equipment Operate Chromatography Process Equipment The selected candidate wil be exposed and will have experience on the following:

1. General Knowledge on Biotechnology manufacturing operations and equipment such as Bioreactors,

Chromatography systems, Tangential Flow Filtration and critical utilities associated. 2. General Knowledge on Active Pharmaceutical Ingredient operations and processes such as reactors, solvent

distribution systems, hydrogenators filtration and drying systems and critical utilities associated. 3. Equipment / Process Equipment knowledge to perform troubleshooting of equipment failures or malfunctions

and/or the development of technical assessments. 4. knowledge in the design of maintenance and reliability activities such as job plan, data sheets and equipment

reliability technology. 5. Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance. 6. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety

of assignments in related fields. 7. Application of engineering knowledge in planning and conducting projects. 8. Project management skills and application of concepts. 9. Develop technical solutions to equipment issues requiring the regular use of ingenuity and creativity. 10. Familiarity with documentation in a highly regulated environment. 11. Ability to interpret and apply GLPs and GMPs. 12. Ability to apply engineering science in the analysis and development of maintenance programs for production

equipment’s. 13. Schedule development, Facilitation, Collaboration, Basic project management, Completion and follow-up.

LOCAL BIOLOGICS SKILLS TRAINING (BOOST) PROGRAMME

ENGINEERING – PROJECT MANAGEMENT & PREVENTIVE MAINTENANCE OPTIMZATION Job Posting

SUMMARY Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. This role will serve as support engineer for small project management as wel as in the development and implementation of the Maintenance Philosophy and Preventive Maintenance Optimization program for Amgen Singapore Manufacturing Plant. This will give to the candidate and opportunity to learn about Biotech Process, API Process and Utilities equipment operation and maintenance. Also the opportunity is aligned with most of the core and elective modules highlighted below which will give the candidate a holistic overview the Biologics and Small Molecule Business. Boost Program Modules: Core Modules Follow Good Manufacturing Practices Apply Safety in Process Plant Apply Continuous Process Improvement Techniques Apply Process Quality Control Techniques Perform Emergency Shutdown of Process Plant Elective Modules Operate Inoculation and Fermentation Reactors Apply cGMP Requirements in the Workplace Operate in a Controlled Clean Room Environment Operate Tangential Flow Filtration Process Equipment Operate Chromatography Process Equipment The selected candidate wil be exposed and will have experience on the following:

1. General Knowledge on Biotechnology manufacturing operations and equipment such as Bioreactors,

Chromatography systems, Tangential Flow Filtration and critical utilities associated. 2. General Knowledge on Active Pharmaceutical Ingredient operations and processes such as reactors, solvent

distribution systems, hydrogenators filtration and drying systems and critical utilities associated. 3. Project management skills and application of concepts. 4. Equipment / Process Equipment knowledge to perform troubleshooting of equipment failures or malfunctions

and/or the development of technical assessments. 5. knowledge in the design of maintenance and reliability activities such as job plan, data sheets and equipment

reliability technology. 6. Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance. 7. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety

of assignments in related fields. 8. Application of engineering knowledge in planning and conducting projects. 9. Develop technical solutions to equipment issues requiring the regular use of ingenuity and creativity. 10. Familiarity with documentation in a highly regulated environment. 11. Ability to interpret and apply GLPs and GMPs. 12. Ability to apply engineering science in the analysis and development of maintenance programs for production

equipment’s. 13. Schedule development, Facilitation, Collaboration, Basic project management, Completion and follow-up.

Career Category

Operations

Job Posting Title

Facilities & Engineering – Business services BOOST

Amgen Job Description

The Amgen Singapore Manufacturing (ASM) site consists of a Biologics Manufacturing Facility, Synthetic API Manufacturing Facility, and Manufacturing Support Building. This Maintenance Planner/Scheduler position will support planning and scheduling of maintenance activities throughout the site. In addition, this position will provide technical expertise, reports, analysis and administrative support to the ASM F&E organization. The candidate will gain exposure to the manufacturing process equipment, utility equipment, and transformational improvement efforts being undertaken by the organization. Main Responsibilities:

1. Competence in Computerized Maintenance Management System (CMMS) application structure and workflow process and preferably with Maximo system (CMMS)

2. CMMS administration – Manage CMMS account requests and provide technical assistance to CMMS Client Base

3. Maximo Data Loaders – Ability to use Maximo data loaders to enter or modify bulk data updates.

4. Ensure Computerized Maintenance Management System (CMMS) data is accurate and aligned with maintenance strategy

5. Support maintenance planning, scheduling. 6. Focus staff on high value operational excellence activities in support of strategic goals 7. Work closely with clients and support groups in a team based collaborative environment 8. Metric development/Generation and management for business services/F&E

o Monthly Metrics – Ability to run specific metrics each month including compliance, safety, economics and also CMMS.

o Data analysis. Ability to review and provide detailed analysis of CMMS data. o Excel Queries – Ability to use Excel based queries that connect to the Maximo

database.

9. Any other job assignment as assigned by supervisor

Basic Qualifications

• Degree in Engineering or related field


• Team building skills.

• Strong client facing/customer service skills with the ability to anticipate client business needs, develop

options with recommendations and provide regular effective feedback to clients on work being performed.

• Ability to communicate complex ideas and principles in a manner than non-engineering clients and

decision makers can effectively use in meeting their business objectives.

• Strong time management, organization and prioritization skills

• Display technical mastery in the administration of the Maximo CMMS system

• Demonstrate a high degree of creativity, foresight and mature judgment in anticipating and solving

problems.

• Outstanding computer skills (MS Excel, Outlook, Word, PowerPoint and MS Project)

• Excel SME – Expertise with Excel functions, formulas and charts

• MS Office Suite – Ability to use all the applications in MS Office

Communication Skills – Ability to effectively communicate with varied client base, project team members

and Management.


Career Category

Operations

Job Posting Title

Attach and Train (AnT) EHSS Trainee

Amgen Job Description

Overview:

Reporting to the EHS Manager, this role is created to train and develop environment, health, safety and

sustainability (EHSS) role within the biologics manufacturing. On top of the EHSS support, this role aimed to

develop capability that can contribute strongly in the field of GMP manufacturing, with the candidate

possessing strong understanding in biologics manufacturing processes, its safety and health concerns and

its green technologies particularly in the sound management of single use materials and industrial wastes

management.

In addition to resourcing in safe and healthy work environment within biologics manufacturing processes,

the candidate will gain knowledge and exposure in the processes of drugs (i.e. chemical manufacturing).

He/She will also assist the EHSS team in the aspects of communications, trainings, programs,

documentation and performance improvement.

Key Responsibilities:

• Understudy biologics manufacturing processes and equipment ergonomics (i.e. human factor

engineering) at Amgen Singapore and work with employees to develop sustainable improvement

measures

• Assist in the deployment of industrial hygiene plan implementation (i.e. air quality/noise/illuminance,

etc.) and identify potential opportunities to reduce health and safety risks

• Participate in plant safety and health improvement programs for manufacturing employees in

accordance to plant priorities (i.e. Spill containment and mitigation, chemical safety, powered industrial

truck safety, etc.)

• Improve EHSS training programs for GMP areas and updating site’s training need analysis to support

compliance. Establish tools to measure effectiveness of EHSS trainings in the required training

modules.

• Resource the site in generation of key performance indicator in EHSS. Perform EHSS data analysis

using SpotFire to generate meaningful EHSS data for the site to assist in goal setting and priorities

allocation.

• Render assistance in various EHSS programs such as process safety management, wastes reduction

program, internal audits/inspections, etc. in accordance to Amgen and local requirements.


• Support the overall EHSS documentation control and preparation of playbooks for compliance audit

readiness by Corporate Amgen.

• Assist in EHSS promotional activities and communications to the site. Develop creative and effective

communication tools to support EHSS communications on site


- Secondary/tertiary education from recognized educational institution and currently pursuing tertiary

education in Singapore.

- Preference for Science/Biology/Biotechnology/Industrial Safety students or those with relevant

background supporting this role


• Competent user of Microsoft Outlook, WORD, PowerPoint & Excel

• Being methodical and attentive to detail

• Proactive/solution orientated approach

• Communicating and presenting effectively

• Positive attitude with passion of learning new things

Amgen is an equal opportunity employer

*Country (State/Region)

Singapore

*Location (City)

Singapore


Associate QC - Bio


Role Description:

• Execute routine product and raw material testing, equipment procurement, installation commissioning, qualification, reagent and sample qualification and method transfers. • Perform sample management duties which may include movemet and storage of samples, reconciliation of sample receipt and aliquoting of samples, and supporting shipment of samples to Amgen network sites and contract labs.

Education / Licenses • Degree in Chemistry, Chemical Engineering Science or related technological field OR • Diploma and 3-4 years of directly related experience Relevant Experience • 1-2 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production and testing experience preferred.

Competencies / Skills • Should have knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods. • Experience with Quality Control testing and laboratory operations for common pharmacopeia testing methods and equipment (HPLC, wet chemistry, spectrophotometry (NIR, FT-IR), pH, conductivity, TOC) • GMP laboratory operation including conducting sample management and data management • Good communication skills (technical writing and verbal communication/presentation) • Interact effectively with variety of communication and working styles and ability to work well in teams • Ability to manage multiple simultaneous activities in a rapidly changing environment • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to assay suitability and comparability.


Job Description

QA Analyst (Quality Management System)


Role Description Responsible for Document management system (EDMQ) project update and health of quality system • Assist to manage project update and complete assigned project tasks • Provide assistance to site users in processing documents in the system • Troubleshoot system-related issues with network team

Record creation and maintenance for document archival system for site generated paper records • Create electronic record in Infolinx for each document to be archived • Assemble scanned/recorded documents for off-site storage • Retrieval of records for destruction or inspection readiness purpose

Other administrative /clerical tasks • Assist with Infolinx training and registration for new hire • Assist with document coordination workflows • Inventory / requisitions manamgent for project

Education / Licenses • Degree in Science OR • Diploma / NITEC in Biomedical Sciences / Biotechnology or related technological field with 2-3 related working

experience

Relevant Experience • Project management experience • Has knowledge of 5s / process improvement • Familiar with quality system such as documenet management and archival system • Proficient in MS office

Competencies / Skills • Demonstrated ability to coordinate multi-functional teams. • Excellent interpersonal relationship skills • Excellent oral and written communication skills. • Ability to work independently and as a team player. • Ability to manage multiple simultaneous activities in a rapidly changing environment

Additonal Requirements NA

Public Information

Analyst, Quality Assurance (PQA)

Responsible for providing oversight for Quality on-the-floor and operations support, the

Associate QA will support manufacturing operations and IPC testing through purposeful presence

on the floor, and support of complex manufacturing investigations, change control, and

unexpected result investigations.

Responsibilities include:

• Support the maturation and continuous improvement of Amgen quality systems, including On-the-floor

quality oversight, raw materials release, non-conformances, change control and CAPA and ensure that the

systems are managed in compliance with cGMP expectations

• Participate in root cause investigations for non-conformances

• Review of nonconformance investigations, change controls, and other quality records (with focus on highly

complex records) such as electronic batch records, SOPs, logbooks and work orders

• Support in regulatory inspections, and interact directly with regulatory inspectors

• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality,

stability program, product quality review, customer complaint investigation


Doctorate degree in Science and 1 years of directly related experience

OR

Master’s degree in Science and 1-2 years of directly related experience

OR

Undergraduate degree in Science and 1-3 years of directly related experience

OR

Undergraduate diploma in Science and 5 years of directly related experience


• Fluency in written and spoken English

• 1-3 years related work experience (manufacturing, process development, or quality assurance) in the

pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and

demonstrated experience in quality assurance, and quality systems.

• Direct experience with bulk manufacturing of biopharmaceuticals preferred.

• Demonstrated proficiency of written and verbal communication skills (including technical writing and

presentations) with ability to communicate and collaborate effectively with technical and senior

management staff

Job Description

Associate Compliance


Role Description: • Inspection -

o Execute Inspection Readiness Plan for Domestic and International Regulatory Inspections o Follow up on Site Inspection Commitments to ensure timely closure and adequacy

• Audits –

o Execute Internal Audit program through participating in site specific or multisite internal audits o Follow up on Internal Audit Commitments to ensure timely closure and adequacy

• Management Review –

o Maintains Site performance metrics

• Annual Product Quality - o Consolidate Product Quality reports for Product Quality Lead

• General -

o Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply

o Provides evaluation and delivery of compliance input on site nonconformance investigations, change controls and/or CAPAs. In addition, review of cGMP documents to ensure changes cause not impact to site regulatory commitments

o Participate in global networks and initiatives

Education / Licenses • Degree in Chemistry, Chemical Engineering Science or related technological field OR • Diploma and 3-4 years of directly related experience

Relevant Experience • NA

Competencies / Skills • Demonstrated ability to coordinate multi-functional project teams and deliver on schedule. • Excellent interpersonal relationship skills • Excellent oral and written communication skills. • Ability to work independently and as a team player. • Ability to manage multiple simultaneous activities in a rapidly changing environment


Public Information Job Description

Analyst QA (Incoming Materials)


Role Description: • Perform routine incoming QA disposition for incoming raw materials and cell banks • Provide quality oversight in operations related to incoming raw materials, warehouse, procurement and shipping

which may include (but not limited to) - Review and approve standard operating procedures / documents related to Warehouse, Procurement, Incoming Material Sampling, Shipping Operations - Review non-conformances, corrective action / preventive actions (CAPA) and change controls associated with SAP ERP Material Master Data, Warehouse Operations and Shipping Operations - Review and approve relevant commissioning and qualification / validation documents for warehouse operations

Education / Licenses • Degree in Chemistry, Chemical Engineering Science or related technological field OR • Diploma and 3-4 years of directly related experience

Relevant Experience • NA

Competencies / Skills • Demonstrated ability to coordinate multi-functional project teams and deliver on schedule. • Excellent interpersonal relationship skills • Excellent oral and written communication skills. • Ability to work independently and as a team player. • Ability to manage multiple simultaneous activities in a rapidly changing environment


job description mfg process technician- bio · instrument technician is responsible for the daily...

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