Specialist Quality Assurance - Day Shift (Chepachet)
Employment Type: Full-Time
The Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and engineering staff during the AR 30 startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations. The PQA position will facilitate real-time decision making to ensure adherence to Good Manufacturing Practices (GMP) quality requirements. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing, Facilities & Engineering and Quality staff providing coaching, guidance and direction in regards to deviations, quality systems and compliance.
The initial focus of this role will be on the AR 30 startup during Admin Day shift to prepare the new facility for Operational Readiness. After the facility startup phase, the successful incumbent will be expected to transition to a 12-hour rotating shift work schedule. The shift pattern will be a 7AM - 7PM structure with a rotation that offers an average of 14 days on shift per month with every other weekend off.Responsibilities
- Quality oversight of AR 30 startup activities for facilities, utilities, equipment, systems and process with alignment and integration into the Amgen Quality Systems, including:
- Interview candidates to build the AR 30 PQA team
- Author/review/approve quality documents, such as: Standard Operating Procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports
- Oversee execution of and change management related to the following: factory acceptance, commissioning tests, facility qualifications and validation activities
- Establish and enable LEAN practices
- Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
- Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations
- Oversee and provide guidance during on-the-floor analytical testing
- Audit and inspection support
- Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
- Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
- Assess changes that could potentially impact product quality
- Provide management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks
- Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks
- Perform training activities
- Drive operational improvement initiatives, programs and projects
Master's degree and 3 years of Quality or Manufacturing experience
Bachelor's degree and 5 years of Quality or Manufacturing experience
Associate's degree and 10 years of Quality or Manufacturing experience
High school diploma / GED and 12 years of Quality or Manufacturing experiencePreferred Qualifications
- Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
- Previous QA oversight of manufacturing, analytical and engineering activities
- Experience in investigations, change controls, and CAPAs processes system knowledge
- Experience and training in EDMQ, Trackwise, Maximo, LIMS
- Experience in managing multiple, competing priorities in a fast-paced environment
- Experience leading and/or managing teams
- Direct bulk drug substance and drug product experience
- 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
- Ability to solve complex problems and make scientific risk-based decisions
- Experience representing Amgen while interacting with representatives of regulatory agencies
- Experience of trending analysis
- Demonstrated proficiency using Excel, Word and Power Point
- Open to travel
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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