Specialist QA - AML 6 Quality Systems

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Job description

Specialist QA AML 6 Quality Systems

Live

What you will do

Lets do this. Lets change the world! In this vital role you will oversight quality systems, you will be responsible to ensure that pharmaceutical products are manufactured, tested, stored and distributed according to cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products. Specific responsibilities include but are not limited to:

• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
• Performs review, approval and tracking of cGMP processes, procedures, assays, documents, and records, including Nonconformances, CAPAs, Change Control, Validation, Periodic Reviews, Risk Assessments, Electronic Batch Records, Work Orders, and Job Plans.
• Supports Continuous Improvement initiatives, programs, and projects.
• Ensures that deviations from established procedures are investigated and detailed per procedures.
• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in alignment with established procedures
• Alerts senior management of quality, compliance, supply, and safety risks.
• Supports internal/external audits and inspections as part of the audit/inspection management team as needed.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients!

The Specialist Quality Assurance professional we seek is an individual contributor leader with these qualifications.

Doctorate degree

or

Masters degree and 3 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment

or

Bachelors degree & 5 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment

What we expect of you

• Educational background in Life Science and/or Engineering.
• Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
• Hands on experience in electronic systems for instance: Documentations platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
• Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.