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

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

Job summary

Aequor is seeking a Quality Assurance Senior Associate for a 12-month, on-site role in Holly Springs, NC. You will work with plant manufacturing and quality teams to ensure GMP compliance across bulk drug substance operations and new product introductions.

The role requires hands-on PQA background, cGMP oversight, and experience driving deviations, CAPAs, and regulatory readiness. Shift work with weekends/nights may apply, and contract W2 terms are offered.

Qualifications

• Hands-on PQA experience on the manufacturing floor.
• Strong knowledge of GMP/GDP requirements and documentation practices.
• Experience supporting audits and regulatory 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.

Skills

Quality Assurance

GMP/GDP

PQA background

cGMP oversight

Manufacturing

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.