Reporting directly to the Director of Quality, this Specialist works closely with the Quality Control group to coordinate the timely release of materials and goods in support of manufacturing and business needs.
Responsibilities include:
- Support manufacturing by monitoring processes and performing in-process Quality Assurance checks to ensure product conformity to specifications.
- Work with management to ensure current Good Manufacturing Practices (cGMP) are followed.
- Release/approve raw materials for production.
- Perform Final Inspection, documentation review and Finished Goods release activities.
- Assist with corrective action investigations and nonconforming product reports.
- Assist with Quality Systems maintenance and continuous improvement activities.
- Monitor QA metrics and frequently reporting to QA management.
- Assure that products, processes, facilities and systems conform to quality standards ISO 9001 & 13485, cGMP and governmental regulations.
- Author and review specifications and operating procedures with Manufacturing, Engineering and Quality Assurance departments.
- Review Validation protocols and reports for equipment, computerized systems and manufacturing process for compliance to requirements
- Support implementation of MasterControl modules including execution of test scripts
- Participate in/complete projects as assigned
Requirements:
The successful candidate must be able to work overtime and be flexible in start times to support manufacturing and business needs. Good written and verbal communication skills are required. Must be detail oriented.
Education/Experience
QA Specialist position requires BA/BS in Life Sciences or chemistry, and a minimum of 3 years related experience in a cGMP Quality Assurance, Quality Control or production environment. Validation experience preferred.