Specialist Quality Assurance
The Quality Assurance Specialist will be accountable ARI site Change Control Business Process Owner (BPO) and PQA Production Floor (Administrative shift). The focus of this role will be to support the change control network as the ARI site change control BPO and support PQA Production Floor activities.
The PQA Production Floor provides mentor, mentorship 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 the change control network and Global Process Owner (GPO) on change control process changes, ARI site management reviews metrics, develop and deliver learning group trainings. Additionally, this position also provides opportunities to work with Manufacturing, Quality control (QC), Facilities/Engineering and Process Development on major deviations, change controls, CAPAs, New Product Introductions/Reintroductions and Site projects etc.Responsibilities:
- ARI site Change Control Business Process Owner (BPO), work with the change control network and Global Process Owner (GPO) on change control process changes, global and site MR metrics, develop and deliver learning groups trainings, support ARI site with change control process questions.
- 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.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products stay in sync with cGMP practices and other applicable regulations.
- Perform QA review, and approval of cGMP processes, procedures, documents and records, including but not limited to Deviations, Corrective Action/Preventative Actions (CAPA), Change Control records, validations, and Raw Materials and Drug Substance documentation.
- Establish and enable LEAN practices.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Ensure that deviations from established procedures are investigated and detailed per procedures.
- Alert senior management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit roll out of required tasks.
- 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 change controls, deviation investigations, and CAPAs processes system knowledge
- Ability to evaluate compliance issues and harmonize with regulatory inspectors
- Experience and training in Trackwise, CDOCS, Maximo, LIMS, MES
- 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
- Excellent skills 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 sophisticated problems and make scientific risk-based decisions
- Experience representing Amgen while interacting with representatives of regulatory agencies
- Experience of trending analysis
- Proficient 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 sophisticated 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 uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.#Operation21
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.
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.