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Manager/Senior Manager, QC Data Review, CMC Quality Control

Brisbane, MA 94005

Posted: 09/11/2023 Employment Type: Contract Job Category: Quality Job Number: 3661

Job Description

  • The QC Data Review Manager/Senior Manager, of QC CMC will work on one or more products.
  • Perform review of analytical release and stability data, data integrity, laboratory documentation, stability reports, specifications, specification setting reports and other QC/analytical documents.
  • Participate in the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
  • Generate QC documents including, but not limited to, CoAs, specifications, specification justification reports, reference standard qualification reports and risk assessment
  • Work within QC and with QA and other team members to address review comments on QC/analytical documents
  • Manage/assist the document creations and reviews via Veeva Document System
  • Create and update batch analysis tables for release data
  • Create Excel/JMP tables and graphs/charts for release and stability data trending
  • Initiate and manage change controls, deviations and CAPA with Veeva Document System
  • Assist in OOS/OOT/Deviation investigations
  • Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support lot release and stability testing.
  • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.

Requirements / Qualifications:
  • Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
  • Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Working experience and knowledge in a wide variety of quality control release and stability methodologies is highly desirable
  • Good oral and written communication skills and a fast learner
  • Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines
  • Proficiency in MS Office, Word and Excel
  • Proficient in statistical analysis software desired (Excel/JMP)
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