Westaff is looking for a direct hire of a Director of Quality Assurance to coordinate all phases and duties of quality control for overseeing the manufacturing and distribution of products, overseeing activities of quality control laboratories, documentation control department and all regulatory functions.
Essential Duties and Responsibilities:
- Plan, direct or coordinate quality assurance programs and formulate quality control policies.
- Oversee compliance and implementation of the FDA Current Good Manufacturing Practices.
- Promote cGMP compliance through training and monitoring SOP effectively.
- Provide training for new and existing personnel in FDA cGMP 21 Part 111 and other regulations required.
- Meet with production manager, department supervisors and production personnel to review SOPs, training and implement cGMP compliance and improvements.
- Issue Corrective and Preventative Action's to applicable departments as required, as well as reviewing/completing CAPA's and implementing improvements such as updating SOP's and training sessions.
- Manage internal audit programs and participate in audits.
- Continue to train/lead for improvements.
- Review SOPs for completeness and compliance to cGMP regulations.
- Represent on all company safety committees.
- Manage Document control activity-including raw material and finished good specifications, training documents, environment control, product test results and releases.
- Review and filing of batch records, specifications and product approval of all companies
- Insure appropriate laboratory testing is completed and expanded when necessary.