Sr. Associate Plant QA Night Shift

Sr. Associate Plant QA Night Shift What you will do

In this role as Senior Associate Plant QA you will work in a shift system, primarily providing QA guidance and support to AOH production. You will perform Quality Batch Record Review of all commercial batches labeled and packed at AOH, and support various QA related projects and systems. You will also establish effective working relationships with production operators, line leads, shift supervisors, warehouse, facilities, maintenance, and engineering.

• Provide daily guidance and support to production staff regarding compliance with SOPs and Work Instructions.
• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
• Act as first point of contact for production queries (quality related) during packaging and labeling operations.
• Lead, mentor, and coach operations and support personnel on quality matters, driving the site quality culture.
• Review and approve batch production records and other GMP documentation; manage data entries before production activities.
• Perform finished product checks during commercial production runs.
• Compile and review batch records for lots assembled, packaged, and labeled at AOH in preparation for batch disposition.
• Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms.
• Review and approve Deviation, CAPA, and Change Control records.
• Participate in self‑led inspections and support internal/external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives.
• Adhere to safety rules and maintain a safe work environment in line with EHSS corporate and site goals.

Basic Qualifications:

• High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• OR Associate’s + 2 years of Quality and/or GMP Manufacturing experience
• OR Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
• OR Master’s degree

Preferred Qualifications:

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
• Experience in GMP/GCP operations or similar regulated industry
• Affinity with digital innovation, data sciences, and Quality engineering
• Experience with raw material receipt, inspection & sampling
• Excellent verbal and written communication skills and strong interpersonal skills
• Great attention to detail and high accuracy in task execution and GMP documentation
• Ability to work autonomously, providing updates to senior management and identifying potential issues
• Strong organizational skills, following assignments through to completion
• Direct experience with ERP software (SAP), Track Wise, CDOCS, etc.

Amgen offers a Total Rewards Plan that includes health and welfare plans, retirement and savings plans with company contributions, group medical, dental, vision, life and disability insurance, flexible spending accounts, discretionary annual bonus, stock‑based incentives, award‑winning time‑off plans, and flexible work models such as remote and hybrid arrangements where possible.

Sponsorship for this role is not guaranteed.

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, disability status, or any other basis protected by applicable law.

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.