Specialist Quality Assurance
Job ID: R-101821
Location: West Greenwich, RI, US 02817
The Specialist Quality Assurance will be responsible to support PQA Off the Floor and on the floor activities. The role may include Quality Validation, Raw Materials and Drug Substance Disposition activities as required by the needs of the department. The PQA off the floor team provides coaching, guidance and direction to Manufacturing, Quality Control, Process Development, Supply Chain and Facilities & Engineering staff regarding compliance and quality systems. This position provides the opportunity to work directly with Manufacturing and other support groups on major deviations, change controls, CAPAs, New Product Introductions/Re-introductions, Site projects etc.
The focus of this role will be to support PQA Off the Floor activities but may include PQA On the Floor and Quality Validation activities as required by the needs of the department. This position also provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations on the floor.
- Perform ownership, QA review, and QA approval of cGMP processes, procedures, documents and records, including but not limited to Deviations, Corrective Actions/Preventative Actions (CAPA), Change Control records, Protocols, Engineering Test plans and Validation documents.
- Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
- Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
- Establish and enable LEAN practices.
- Oversee and provide guidance during on-the-floor analytical testing.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Elevate to Senior management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit execution of required tasks.
- Drive operational improvement initiatives, programs and projects.
- Doctorate degree
- Master's degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience
- Bachelor's degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience
- Associate's degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
- High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering 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 deviation investigations, change controls, and CAPAs and EV processes system knowledge
- Direct Validation experience with pharmaceutical or biopharmaceutical processes
- Ability to evaluate compliance issues and interact with regulatory inspectors
- Experience and training in CDOCS, 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
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.