Quality Assurance Generalist (3rd Shift)
- Reputable manufacturer of specialty health products who are industry leaders in setting and adhering to high standards in manufacturing and quality control.
- Company focuses on researching and developing products to promote consumer health and is highly regarded in the industry for their advancements in the medical space.
SCOPE OF THE ROLE:
· The Quality Assurance Generalist I (QAG I) reports to the Quality Assurance Supervisor.
· This position is 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.
· 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.
- 2+ years’ experience in the pharmaceutical or dietary supplement manufacturing environment preferred.
- Auditing experience and troubleshooting is a plus.
- High School Diploma or equivalent required.
- Great enthusiasm and hard work ethic is a must.
- The ability to lift 50lbs.
- Detail oriented and team centered approach is required.
- Good computer skills on all general software is needed MS Excel, MS Word, Lotus Notes, etc.