Sr. Associate Quality
The Sr. Associate will be responsible for Quality On the Floor in support of Manufacturing activities. This position 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. Shift 5 Sat-Mon (12 Hrs). This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems.
Responsibilities include the following:
Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
Performs review and approval of cGMP processes, procedures, documents, and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),
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.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Alerts senior management of quality, compliance, supply and safety risks.
Completes required assigned training to permit execution of required tasks.
Drive operational improvement initiatives, programs and projects.
Bachelors degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Associates degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
High school diploma / GED and 8 years of Quality, Manufacturing, Validation, 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 investigations, change controls, and CAPAs 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 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
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 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.
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.