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Quality Assurance/Manufacturing Associate (Batch Records, cGMP Manufacturing)

Job

Aequor

Holly Springs, NC (In Person)

Full-Time

Posted 3 days ago (Updated 1 day ago) • Actively hiring

Expires 7/24/2026

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Job Description

Quality Assurance/Manufacturing Associate (Batch Records, cGMP Manufacturing) at Aequor Quality Assurance/Manufacturing Associate (Batch Records, cGMP Manufacturing) at Aequor in holly springs, North Carolina Posted in about 3 hours ago.
Type:
full-time
Job Description:
Job Title:
Quality Assurance Senior Associate Location:
Holly Springs NC (100% Onsite)
Duration:
12 Months with possible extension
Terms:
Contract W2
Description:
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 Let's do this. Let's change the world. The North Carolina (ANC) 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 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.