Sr. Specialist, External QCApply Now
Location: Norwood, Massachusetts 02139
Employment Type: Contract
Contract Length: 9+ months
Job Summary: This individual will support External QC testing for outsourced commercial manufacturing testing and will support QC administrative functions with contract testing laboratories and contract manufacturing organizations.
- Assist in testing program support at contract manufacturing organizations and contract laboratories for raw materials, drug substance and drug products
- Participate in cross-functional project teams to lead Quality Control related activities
- Provide QC support for method transfers and validations projects as required
- Troubleshoot and provide further technical support for method, material, and instrument related issues
- Review/approve procedures, protocols and reports
- Support technical assessments of quality events such as deviations, investigations, and change controls
- Bachelor’s degree in a relevant scientific discipline
- Minimum 5+ years in a cGMP laboratory and/or GMP manufacturing with focus in analytical chemistry or Biochemistry
- Knowledge of compendia and analytical test methods, technical writing, and knowledge of the QC requirements
- Experience/Knowledge of Veeva and Lab Vantage LIMS
- Knowledge of method transfers and qualifications
- Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively
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