Quality Assurance Senior Associate

Aequor; Holly Springs (NC); Presencial; USD 95.000 - 135.000; Jornada completa

Descripción de la vacante

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

Formación

• Manufacturing and PQA background required.

Responsabilidades

• 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.

Conocimientos

PQA background

Manufacturing background

Descripción del empleo

Note: The role will be sourced at open market rate***

Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights)

Shift will be determined once identified, 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.