Senior Quality Assurance Specialist Contractor

Position Summary

We are looking for a Senior Quality Assurance Specialist to support quality assurance activities in support of the manufacture, testing, and release of clinical product. The QA Specialist will review manufacturing batch records, deviations, change controls and disposition of clinical drug product. The Senior Quality Assurance Specialist is responsible for ensuring reviews of Manufacturing and Quality Assurance records are certified for compliance to in-house specifications/standards and Good Manufacturing Practices. In addition, the Sr. QA Specialist will work to identify key continuous improvement opportunities to ensure quality systems are aligned with business strategy, industry standards and global regulatory expectations.

Primary Responsibilities

  • Reviews manufacturing and support records to certify compliance with specifications and procedures

  • Assists Quality Assurance Management with product disposition activities.

  • Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending

  • Works closely with Manufacturing and Analytical to resolve open issues resulting from record reviews and deviation issues

  • Work with all departments to ensure timely completion of manufacturing batch records, deviations, CAPAs, and change controls

  • Input batch/lot information into electronic databases and generate reports from these systems

  • Review Manufacturing batch records and completes required documentation for batch disposition

  • Create, revise and review Quality System documents, including Standard Operating Procedures, protocols, and reports

  • Performs data audits, as needed

  • Provide training to site personnel and contractors on GMP and quality system procedures, as needed

Competencies

  • Ability to prioritize daily activities in order to meet timelines in a fast-paced environment

  • Ability to monitor and report on assigned tasks, goals and objectives

Education & Experience Required

  • Bachelor’s degree in Life Sciences, or related field and 5 to 8 years experience in biopharmaceutical quality assurance

  • Excellent written and verbal communication skills

  • Experience with clinical product programs is required

  • Experience personalized medicine or cell therapy products is a bonus