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Amgen Senior Associate Quality Assurance- Third Shift in West Greenwich, Rhode Island

The Quality Assurance Sr Associate will be responsible for PQA On the Floor in support of Manufacturing activities. Amgen’s Quality Assurance On-the-Floor position Shift 3 schedule is 4 days a week Tuesday through Friday 10 hours per day 10pm – 8am

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. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff and provide coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff regarding compliance and quality systems!

Responsibilities include the following:

  • 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 follow 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.

  • Lead all aspects of and provide guidance during on-the-floor analytical testing.

  • Ensure that changes that could potentially impact product quality are assessed according to procedures.

  • Ensure that deviations from established procedures are investigated and documented per procedures.

  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

  • Alert senior management of quality, compliance, supply and safety risks.

  • Complete required assigned training to permit execution of required tasks.

  • Drive operational improvement initiatives, programs and projects.

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree and 2 years of Quality/Manufacturing experience

OR

Associate’s degree and 6 years of Quality/Manufacturing experience

OR

High school diploma / GED and 8 years of Quality/Manufacturing experience

Preferred Qualifications:

  • Master's Degree & 1 year of Quality/Manufacturing experience

  • cGMP Experience

  • Experience in general compendia testing

  • Experience using LIMS and/or SmartLab

  • Experience and knowledge of Data Integrity Requirements of QC Systems

  • Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)

  • Excellent problem-solving capabilities and attention to detail

  • Experience of collaboration within and across functional areas and outstanding customer service focus

  • Excellent written and verbal communication skills

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.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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 you without regard to your 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 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.

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.

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