Job Description
North Carolina - Fully Onsite - Mon-Friday - Flexible shift schedule (daytime)
Ideal Candidate: Associates' degree and a certificate such as Bioworks and 3-4 YOE or B.S. and 1-2 YOE in a manufacturing or quality assurance (QA) background in a manufacturing environment.
Nice to have: Able to work both independently and within a team environment.
Preferred experience: 1-2 years of start-up or greenfield site experience
Job Details
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.
The PQA team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations.
* Staff for the PQA team are on-site workers.
Primary responsibilities of this position include:
•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 manufacturing process and 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.
Skills: 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 minor deviations
•Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.
Day to Day
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.
•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.
•Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
Job Tags
Flexible hours, Shift work,