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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Senior Associate, Quality Assurance
Posted: 03/10/2025
2025-03-10
2025-04-17
Employment Type:
Contract
Job Category: Quality
Job Number: 4335
Job Description
The Sr. Associate, Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for ongoing 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:
Requirements / Qualifications:
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 production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
- 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), change control records and validations
- Oversee and provide guidance during on-the-floor analytical testing
- 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.
Requirements / Qualifications:
- High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree
- Knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required.
- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment?. Strong GMP and GDP Behaviors.
- Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with deviations.
- Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.
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