Job ID: #8565

Senior QC Manager

Cambridge, MA
Science Science
QA / QC

 

Responsibilities of the Senior QC Manager:

  • Function as lead for stability, method qualification and validation programs.
  • Develop, review and approval procedures, protocols and reports.
  • Technical review of QC data associated with batch records, deviations, change controls and reports
  • Lead the Method Validation team to collaborate cross- functionally on internal and external Method development, validation, optimization and Method life cycle initiatives.
  • Write, review, and approve Standard Operating Procedures (SOPs)
  • Ensure all documentation complies with GXP regulations and industry guidelines
  • Track and document all Quality Control activities such as stability, reference standard inventory, method validation status
  • Facilitate review, revision, and approval activities of QC documents ensuring both internal and external systems comply with regulatory requirements
  • Manage all OOS investigations and drive to closure
  • Trend and report QC related metrics (testing turn-around times, investigations, stability, reference standard inventory) both internally and from external vendors

Requirements of the Senior QC Manager:

  • BS degree in science and 5+ years experience in Quality Control in a GMP environment
  • Experience managing Contract Testing Organizations
  • Prior QC experience in pharmaceutical/biotech environment
  • Knowledge of FDA/EMA/ICH regulations and experience with GMP guidelines
  • Excellent attention to detail, project and time management skills, and the ability to manage people, multiple priorities with aggressive timelines
  • Demonstrated proficiency with Quality System Records, OOS, Deviations, Change Controls and CAPAs

 

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.

Commonwealth Sciences, Inc.

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Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering 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.