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

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.