Onsite QA Senior Associate – Manufacturing

Aequor; Holly Springs (NC); On-site; USD 55,000 - 83,000; Full time

Job summary

Aequor is seeking a Quality Assurance Senior Associate for a 12-month onsite contract in Holly Springs, NC. The role supports manufacturing, quality systems, and regulatory readiness across development, clinical, and commercial operations.

The Senior Associate on the plant QA team will facilitate real-time decision-making to ensure GMP compliance, coaching manufacturing staff, and driving CAPA closures, deviations, and audits as needed.

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.

Job description

Aequor is seeking a Quality Assurance Senior Associate for a 12-month onsite contract in Holly Springs, NC. The role supports manufacturing, quality systems, and regulatory readiness across development, clinical, and commercial operations.

The Senior Associate on the plant QA team will facilitate real-time decision-making to ensure GMP compliance, coaching manufacturing staff, and driving CAPA closures, deviations, and audits as needed.