Laboratory QA Specialist

POSITION TITLE: Laboratory QA Specialist

REPORT TO: Senior Laboratory QA Manager


Responsible for QA related projects that vary in scope, complexity and size. Oversee QC laboratory data to ensure compliance with current GMPs.


  • Review laboratory data and reports to ensure accuracy.
  • Maintain QA records (i.e. logbooks, equipment records, specifications, procedures).
  • Review procedures, SOPs, instrument IQ / OQ protocols and reports, method validation and implementation protocols and reports, and other documentation for regulatory compliance.
  • Coordinate responses to internal, customer and regulatory inspection observations.
  • Coordinate and perform internal audits.
  • Monitor inspection trends for impact on laboratory operations.
  • Ensure the proper storage of controlled documentation like archives and back-ups.
  • Maintain documentation, certifications, and training records.
  • Establish, institute and provide new employee orientation for QA related activities.
  • Perform other related duties and responsibilities as assigned.


  • Bachelor’s Degree in Chemistry, Biology, or Biochemistry and two (2) to five (5) years of experience in the same or closely related cGMP environment.
  • Demonstrated competence in QA related activities through education and experience.
  • Demonstrated ability to work under minimum supervision; exhibit leadership skills to coordinate personnel and projects on various levels.
  • Excellent oral and written communication skills are required.
  • Experience in sterile product manufacturing is a must.

To apply for this position, please email your resume with cover letter to .