Job ID: #8775

QC Manager

Cambridge, MA
Work For Us
Management

 

Responsibilities of the 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
  • 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
  • Interface with business partners and external vendors in ensuring quality control activities are prioritized and completed on time and with a high degree of quality
  • Contribute to the development of new quality Control systems and standards
  • Manage operating cost for outsource testing as required

Requirements of the QC Manager:

  • BS degree in science or engineering with a minimum of 5 years of Quality Control experience 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

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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.