Job Description

Job Title: Quality Assurance Senior Associate

Duration: 12 Months

Location: Holly Springs, NC 27540

Note : Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule.

Must have : Manufacturing and PQA background

Summary:

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. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance

Responsibilities :

• 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 relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.

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

• 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; may directly interact with regulatory agencies during on-site inspections.

Requirements:

Previous work on GNP Facilities

PQA or Mfg preferably Drug Substance Experience

Previous work with Batch records/Deviations/Qa Oversight

Nice to have: B.S. degree

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