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Jobs · Quality Assurance · Ohio

Sr. Associate Plant QA 12 Hour Day Shift (6am - 6:30pm)

BioSpace · New Albany, OH · 1 mo ago
Quality AssuranceFull-time

About the role

At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. 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.

Qualifications

Basic Qualifications:

  • 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

Preferred Qualifications:

  • Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
  • Experience in and knowledge of GMP/GCP operations or similarly regulated industry.
  • Affinity with digital innovation, data sciences, and Quality engineering.
  • Experience with raw material receipt, inspection, and sampling.
  • Highly effective verbal and written communication skills, strong interpersonal skills.
  • 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 (SAP), TrackWise, CDOCS, etc.

Benefits

  • 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.
    • 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 the careers site. Actual salary will vary based on relevant skills, experience, and qualifications.

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