Sr. Associate Plant QA 12 Day Shift (6am- 6pm)

Join Amgen’s mission of serving patients. At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines.

About the role

As Senior Associate Plant QA, you will work in a shift system, 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. This role involves direct collaboration with a wide range of stakeholders, including production operators, line leads, shift supervisors, warehouse, facilities, maintenance, and engineering.

Responsibilities

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
• Act as the 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 while driving the site Quality culture.
• Review and approve batch production records and other GMP documentation in support of daily operations, including 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 Standard Operating Procedures (SOPs), Work Instructions, and Forms.
• Review and approve Deviation, CAPA, and Change Control records.
• Participate in self-led inspections and provide support during internal/external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives.
• Adhere to safety rules and maintain a safe work environment by supporting EHSS corporate and site goals.

Requirements

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

Qualifications

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
• Experience in and knowledge of GMP/GCP operations or similarly regulated industries.
• Affinity with digital innovation, data sciences, and Quality engineering.
• Experience with raw material receipt, inspection, and sampling.
• Highly effective verbal and written communication skills, with strong interpersonal abilities.
• Great attention to detail and high degree of accuracy in task execution and GMP documentation.
• Ability to complete tasks autonomously, provide updates to senior management, and identify potential issues.
• Strong organizational skills, including the ability to follow assignments through to completion.
• Direct experience with Enterprise Resource Management software (e.g., SAP), TrackWise, CDOCS.

Benefits

Amgen supports your professional and personal growth with a competitive benefits package and collaborative culture. The Total Rewards Plan may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted on Amgen’s careers site. Actual salary will vary based on relevant skills, experience, and qualifications.

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. Individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.