What are the responsibilities and job description for the Manufacturing Quality Assurance Specialist position at UPM Pharmaceuticals?
Manufacturing Quality Assurance Specialist
UPM Pharmaceuticals, Inc., a mid-sized contract drug development and manufacturing company, located in Bristol, Tennessee is seeking a Manufacturing Quality Assurance Specialist.
Key Responsibilities:
- Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in real time during operations.
- Evaluates deviations through notice of event reports and investigations; assigns and communicates corrective and preventative actions (CAPA) to responsible departments; provides follow-up on CAPA and assesses effectiveness of CAPA.
- Assign disposition to bulk, intermediate, finished product and components based on batch record review for compliance to the current Good Manufacturing Practices, compendia standards, and company specifications. This activity provides authorization for the transfer or use of product or components at significant evaluation points in the manufacturing process and ultimately for the release to distribution. It involves review of the batch record for the completeness and accuracy of entries, adequacy of investigation of deviations and conformance to test results with the established standards.
- Makes decisions of acceptability/rejectability of investigations from operations and the laboratory.
- Evaluate and approve in-process data in accordance with the established specifications to measure conformance of final container contents to label claim. Make decisions concerning out of limits or out of trend in-process situations.
- Determine need, schedule, prepare protocols, and evaluate attribute inspections associated with batch deviations. Evaluate attribute failures. Recommend product disposition from attribute evaluation.
- Leads or responds to quality audits when applicable to assure conformance with regulatory and internal requirements. Has the skills necessary to conduct own internal audits.
- Participates in and provides leadership for Projects as designated by upper management.
- Revises, evaluates, and approves SOPs, as necessary.
- Compile Annual Product Reviews for the commercial market, and evaluate stability data and trends; identify any preventative or corrective actions that would lead to product quality improvements and report them to upper management.
- Participate in customer complaint investigations, as necessary.
- Maintain a working knowledge of government and industry Quality standards.
Knowledge necessary to perform the job:
- Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine disposition of product batches and raw materials.
- Knowledge of manufacturing and laboratory operations, company business plan, validation plan and financial plan.
Education / Experience:
Bachelor's degree in a technical field, i.e., Biology, Chemistry, Engineering, or Pharmacy and six to eight years of related experience and/or training; or equivalent combination of education and experience. Pharmaceutical experience preferred.
Job Type: Full-time
Benefits:
- Employee assistance program
- Employee discount
- Flexible spending account
- Referral program
- Relocation assistance
- Retirement plan
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: In person