Specialist Quality Assurance - Night Shift
The AR30 Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, launch and commercial operations. The PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction in regard to deviations, quality systems and compliance.
The Plant Quality Assurance team shift structure aligns with Manufacturing, which is a 12-hr rotating shift work schedule. For this specific D shift role, the shift pattern will be a 7PM 7AM structure with a rotation that offers an average of 14 days on shift per month with every other weekend off.
- Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.
- 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.
- 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.
- 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.
- 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, as needed.
- Drive operational improvement initiatives, programs and projects.
- Doctorate degree, OR
- Masters degree and 3 years of Quality experience, OR
- Bachelors degree and 5 years of Quality experience, OR
- Associates degree and 10 years of Quality experience, OR
- High school diploma / GED and 12 years of Quality experience
- 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
Join UsIf 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.