Quality Assurance Generalist - Pharmaceutical
We are looking for a Quality Assurance Generalist I (QAG I) who will report to the Quality Assurance Supervisor and be responsible for the daily Quality Assurance support in the Manufacturing and Packaging process on site. They will be required to review all appropriate documents during the production process. In this role, the QAG I will be readily available to support the production process; therefore, this position requires that the associate stays on the production floor for the majority of the work day.
Roles and Responsibilities:
- Providing Quality Assurance presence in the manufacturing and packaging areas through the execution of daily Packaging line and room clearances, In-process inspections, and issuing and tracking of Batch Records.
- Providing input during the revision process of SOPs to cover the work required in the South Carolina facility
- Assisting in the investigation and closing of deviations
- Providing impact on issues that could affect product quality, safety and purity
- Reviewing the preventative maintenance, pest control and calibration records, etc.
- Assisting with the trending and developing metrics to indicate quality system health of the organization
- Assisting Quality Assurance management with the daily operation of the QA Hold area.
- Must be able to effectively communicate with other departments and function within a team environment
- Training on all SOPs, safety procedures and cGMPs as required
- Evaluate and process returned products.
- Other duties as assigned.
This position will be closely associated and work with the following:
- Manufacturing and Packaging Operators
- Quality Associates (QAG II, QA Supervisor, QC, Label Issuance, and Document Control Center)
- Safety, Security and Environmental Services Manager
- Training Coordinator
- Supply Chain Team
- Product Development
- Perform other assigned duties as may be required in meeting company objectives
- Regular attendance is required.
- Communicate effectively with other departments within the organization and function within a team environment.
Minimum Requirements :
- Two years' experience in the pharmaceutical or dietary supplement manufacturing environment preferred. Auditing experience and trouble shooting is a plus.
- Great enthusiasm and hard work ethic is a must. Detail oriented and team centered approach is required. Good compute skills on all general software is needed MS Excel, MS Word, Lotus Notes, etc.
- The ability to lift 50lbs
Education and Experience: This position requires a High School Diploma or equivalent
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