On-the-Floor QA Lead - GMP Compliance & Improvement

Planet Pharma; Holly Springs (NC); On-site; USD 85,000 - 115,000; Full time

Job summary

Planet Pharma is seeking a Senior Associate Plant Quality Assurance (PQA) on-the-floor in North Carolina to partner with Manufacturing and Quality teams on bulk drug substance manufacturing and new product introductions, ensuring GMP, GDP and regulatory adherence.

The role focuses on real-time decision making, deviations, CAPAs, document control, and audits, with potential interaction with regulatory agencies during inspections.

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

Planet Pharma is seeking a Senior Associate Plant Quality Assurance (PQA) on-the-floor in North Carolina to partner with Manufacturing and Quality teams on bulk drug substance manufacturing and new product introductions, ensuring GMP, GDP and regulatory adherence.

The role focuses on real-time decision making, deviations, CAPAs, document control, and audits, with potential interaction with regulatory agencies during inspections.