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Quality Control Specialist

4 months ago

Ayer, United States Mastech Digital Full time

TITLE: Quality Control Specialist (Pharma)

LOCATION: 45 Jackson Road Ayer MA 01432 (100% onsite)

DURATION: 6 months + CTH


  1. Conduct and review investigations of lab deviations and client exceeded concern levels.
  2. Possess the knowledge and ability to conduct and host client and regulatory audits professionally, ethically, and objectively.
  3. Assume the role of the CAPA coordinator. Responsible for overseeing the conduct of the CAPA and organizing meetings and updates as necessary.
  4. Assist the change control coordinator and will assume a role where needed.
  5. Maintain training records and documentation.
  6. Conduct review of internal methods and protocols.
  7. Review documentation such as raw data and reports, quality control records, quality assurance records, and reports for completeness, accuracy, and compliance with methods, protocols, guidelines, and regulations and FDA regulations
  8. Assure proper control of laboratory documentation.
  9. Responsible for the implementation, maintenance, and improvement of quality systems.
  10. Collaborate with managerial reports and trends.
  11. Provide guidance to peers regarding quality and regulatory issues.
  12. Problem-solve quality issues to preserve the original timeline for various projects; tracking progress while accountable for quality system deliverables.
  13. Accountable for overseeing the lab’s adherence to all relevant quality requirements.
  14. Analyze and identify opportunities to reduce process variation.