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Specialist Quality Assurance: Compliance

Woburn, MA 01801
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Job ID: R-101383
Location: Woburn, MA, US 01806

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.

As part of site Quality Compliance function, the Specialist Quality Assurance Compliance will be involved in the participation and leading of internal and external audits; utilizing experience in the auditing of oncolytic virus based end-to-end drug substance and drug products for the global market .

The Specialist Quality Compliance will coordinate and lead, or participate in, Quality Compliance audits of the Amgen Woburn site; including laboratories, manufacturing, service providers and quality systems. Position will apply knowledge of current regulatory regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOP's), in the conduct of these audits.

Responsibilities Include:
  • Review and assess new or revised regulations, standards, and guidelines as related to product testing; provide site with guidance on new regulatory compliance expectations and trends
  • Provide leadership toward resolving site compliance risks
  • Provide compliance support for product quality teams
  • Perform tasks and participate on project teams as assigned to assist in the completion of activities associated with the attainment of group, departmental, team and corporate goals
  • May provide support to inspection management or metrics

Basic Qualifications

Doctorate degree

Master's degree and 3 years of Regulatory Compliance or GMP experience
Bachelor's degree and 5 years of Regulatory Compliance or GMP experience
Associate's degree and 10 years of Regulatory Compliance or GMP experience
High school diploma / GED and 12 years of Regulatory Compliance or GMP experience

Preferred Qualifications
  • MS degree in Science
  • 5+ years of experience in a regulatory compliance position supporting the manufacture and testing of pharmaceutical products
  • Experience performing Good Manufacturing Practices (GMP) audits of manufacturers of biologic and small molecule Active Pharmaceutical Ingredients (API) and Drug Product (DP), and laboratories that perform testing for API and DP
  • Advanced knowledge of U.S. and European regulations, compendia, guidance and industry practice as they pertain to the manufacture and testing of biological products
  • Demonstrated advanced ability to evaluate and apply regulatory requirements and guidelines to applicable situations
  • Excellent verbal and written communication skills, including technical writing
  • Strong ability to lead teams and effectively utilize team resources

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Join Us

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.



Posted: 2020-07-08 Expires: 2020-08-08

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Specialist Quality Assurance: Compliance

Woburn, MA 01801

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