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
We are looking for a Quality Assurance Specialist who will 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 QA Specialist will be readily available to support the Quality Department and the production process; therefore, this position requires the QA Specialist to be flexible based on business need to support QA and business operations hours.
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 computer skills on all general software are 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.