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Senior QA Specialist, Manager
This position will establish and maintain quality engineering methodologies such as design control, change control, quality planning, complaint handling, auditing, CAPA and supplier management. Provide quality engineering support/product risk management and technical problem-solving.
- Review and approval of facility, equipment and manufacturing process/change control documentation.
- Ensure that product and process changes are properly qualified prior to becoming effective. Review validation activities (IQ/OQ/PQ) including protocols and final reports related to manufacturing processes including inspection equipment and analytical test methods.
- Establish and manage the design and development process.
- Manage Product risk management file updates, risk assessments to support complaints, CAPAs, and related product risk assessments.
- Perform training to support compliance to internal procedures and external regulations.
- Develop and enhance measurement, inspection and test systems for existing products and processes. Maintain and develop quality assurance inspection and test procedures and work instructions.
- Coordinate and perform audits of both internal and external operations. Identify compliance risks and report findings to appropriate management with recommendations for resolution.
- Design History Record/Batch record review and product release including review of analytical test data.
- Minimum 5+ years in drug delivery or combination (drug/device) products.
- BA/BS Degree in scientific discipline.
- Strong knowledge of both drug and device cGMP (21 CFR Parts 210, 211 and 820)
- Excellent written and verbal communication skills.
- Experience with analytical and statistical techniques such as DOE.
- Ability to critically evaluate and troubleshoot complex problems is essential. Must take initiative and be solution oriented.
- Must be able to work in a team oriented, fast paced environment with multiple priorities.
If interested, please send your resume and cover letter to Quality@forsightv5.com.