Asepsis, Auditing, Corrective Action, Data Analysis, Documentation, Environmental Work, GMP (Good Manufacturing Practices), Problem Solving Skills, Quality Assurance, Quality Management, Regulatory Compliance, Regulatory Requirements, Sanitation, Standard Operating Procedures (SOP), Startup, Test Program
Description
The Quality Assurance Specialist is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Promote and observe enforcement of Good Manufacturing Practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs) in the facility.
- Perform daily Sanitation Pre-operational Inspections and provide corrective action.
- Assist QA Inspectors in resolving quality issues on the Production floor.
- Assist QA inspectors on the production start up
- Assist in the scheduling and training of QA Inspectors.
- Perform quality checks on return products.
- Act as liaison between QA Inspectors and the Quality Assurance Manager and/or Supervisor
- Maintains time and testing records, reporting weekly.
- Follow Hold procedures when placing or removing product from hold
- Maintains non-conformance and rejection procedures and forms
- Aseptic product and environmental sampling techniques. Maintain plant environmental testing program. Implement and follow-up on corrective actions.
- Maintains and review HACCP SOPs on annual basis or when changes happens
- Other duties as assigned.
- Overtime will be required on an as needed basis.
$19 per hour