Quality Assurance Senior Associate
Aequor JD ·www.aequor.com
Apply direct
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.
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.
Frequently asked questions
Who is hiring for the Quality Assurance Senior Associate role?
Aequor JD is hiring for the Quality Assurance Senior Associate position, a Shazamme client. Apply directly on the employer's career site.
Where is the Quality Assurance Senior Associate job located?
The Quality Assurance Senior Associate role with Aequor JD is based in Holly Springs, NC, US.
Is the Quality Assurance Senior Associate role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Quality Assurance Senior Associate role?
The Quality Assurance Senior Associate position is aimed at senior-level candidates.
How do I apply for the Quality Assurance Senior Associate role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.