External Supply Quality Specialist QA

Career Category

Quality

Job Description

The External Supply Quality Specialist QA is a Deviation SME, representing External Supply as Global Network SME. This role supports the team that uses such Systems or Processes (transactional activities, training, and project management).

Key Responsibilities

• Represent External Supply at the Deviation network as Deviation SME
• Ensure External Supply execution of Deviation Systems and Processes is in alignment with Operating Standards
• Own and Author External Supply trend reporting process using Natural Language Processing (NLP) and statistical tools
• Act as Contract Manufacturing Deviation system owner and grant system access
• Act as SME for Deviations within External Supply, including Identifying key issues, needs, constraints of the External Quality/Supply organization and drive Continuous Improvement solutions for resolution
• Understanding and interpreting of applicable GMP Regulations pertaining to the System or Process of which the SME is representing
• Communicate and ensure alignment on priority decisions
• Perform ownership and QA support of deviation TrackWise records
• Support External Supply staff to resolve questions regarding internal and external deviations /SME
• Provide tactical information to the networks (i.e., metrics to QMR, MR, data analysis, trending, APR)
• Provide Project Management support and ensure teams remain on target with key milestone due dates
• Perform SAP data entry and own Change Controls
• Support audits of internal Systems and Processes
• Drive timely decision making using DAI principles
• Drive Lean continuous improvements and Amgen first mindset

Basic Qualifications

Doctorate degree

OR

Master’s degree & 3 years of Quality or Manufacturing Experience

OR

Bachelor’s degree & 5 years of Quality or Manufacturing experience

OR

Associate degree & 10 years of Quality or Manufacturing experience

OR

High school diploma / GED & 12 years of Quality or Manufacturing experience

Preferred Qualifications

• 4+ years of deviation ownership, quality and/or manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• cGMP Experience
• Ability to oversee multiple projects simultaneously
• Ability to successfully manage workload to timelines
• Familiarity with statistical analysis and basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed and team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to travel up to 10% of time to domestic and international Amgen sites

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.

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 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.

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