Onsite Quality Assurance Lead - GMP/PQA, Floor Operations

Aequor; Holly Springs (NC); On-site; USD 95,000 - 135,000; Full time

Job summary

Aequor in North Carolina is seeking a Sr. Associate Plant Quality Assurance to provide on-the-floor quality oversight for on-going bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations.

You will coordinate with Manufacturing and support groups to ensure GMP/GDP compliance and real-time decision making. The role involves driving CAPA closures, reviewing deviations and change controls, supporting audits, and coaching

Qualifications

• Manufacturing and PQA background required.

Responsibilities

• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP and other applicable regulations.
• Ensure facilities, equipment, materials, organization, processes, and procedures comply with GMP, GDP, safety and other controls.
• Drive closure/completion of cGMP processes, procedures, documents and records, including deviations, investigations, corrective actions/preventive actions (CAPA).
• Ensure production and testing records/results are complete, accurate, and documented per procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure changes that could impact product quality are assessed per procedures.
• Investigate and document deviations from established 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.
• Identify and implement continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may interact with regulatory agencies during on-site inspections.

Skills

PQA background

Manufacturing background

Job description

Aequor in North Carolina is seeking a Sr. Associate Plant Quality Assurance to provide on-the-floor quality oversight for on-going bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations.

You will coordinate with Manufacturing and support groups to ensure GMP/GDP compliance and real-time decision making. The role involves driving CAPA closures, reviewing deviations and change controls, supporting audits, and coaching