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Sr Associate Quality Assurance

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Amgen

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Location:
United States , Holly Springs

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

86928.00 - 106536.00 USD / Year
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Job Description:

In this vital role you will be the Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements.

Job Responsibility:

  • Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
  • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
  • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements
  • Drive closure/completion of cGMP processes, procedures, documents and records
  • Ensure production and testing records/results are complete, accurate, and documented according to procedures
  • Oversee 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
  • Alert senior management of quality, compliance, supply and safety risks
  • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
  • Identification and implementation of continuous improvement opportunities within our processes and systems
  • Support and represent PQA during audits and inspections

Requirements:

  • High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience
  • Associate’s + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience
  • Bachelor’s + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience
  • Master's
  • Strong cGMP and GDP behaviors
  • Experience in biotechnology or pharmaceutical plant start up
  • Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
  • Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
  • Demonstrated experience with deviations records
  • Experience supporting GMP testing laboratories
  • Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines
  • Strong communication skills, both written and oral
  • Demonstrated ability to work as a team player and independently

Nice to have:

  • Experience in biotechnology or pharmaceutical plant start up
  • Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
  • Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
  • Demonstrated experience with deviations records
  • Experience supporting GMP testing laboratories
  • Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines
  • Strong communication skills, both written and oral
  • Demonstrated ability to work as a team player and independently
What we offer:
  • 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
  • Stock-based long-term incentives
  • Award-winning time-off plans

Additional Information:

Job Posted:
March 21, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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