Sr. QA Specialist
Responsibilities of the Sr. QA Specialist:
- Act as QA Lead for tech transfer, process development, and process validation.
- Quality Assurance Lead for external collaborations to provide quality system expertise and help identify solutions and ensure compliance to GMP.
- Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
- Support External Quality partnerships as required in the initiation and follow up of deviations, CAPAs, and change controls.
- Build on relationships within our CTOs and CMOs ensuring issues impacting quality control testing are tracked and resolved in a timely manner.
- Support projects, and global processes alignment as well as continuous improvement and initiatives.
- Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
- Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
Requirements of the Sr. QA Specialist:
- A Bachelor’s or Master’s degree in biology, chemistry or other life science and at least 5 years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment.
- A solid understanding of applicable regulations and guidelines pertaining to pharmaceutical product development, testing, and clinical operations.
- Experience with GMP’s in a working manufacturing environment strongly preferred.
Certified Quality Auditor (CQA) would be a plus.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.