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 per business need.
- Providing input during the revision process of SOPs to cover the work required in the facility.
- Provide support for Label Cage personnel per business need.
- Provide support for Returns per business need.
- Provide initial GMP/Safety training for new hires per business need.
- File training records accordingly.
- 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
- 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
- Provide support/coverage for QA personnel per business need.
- Perform other assigned duties as may be required in meeting company objectives
Two years' experience in the pharmaceutical or dietary supplement manufacturing environment preferred. Auditing experience and troubleshooting 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.