POSITION TITLE: Laboratory QA Specialist
REPORT TO: 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 audit to ensure accuracy.Maintain QA records (i.e. logbooks, equipment records, specifications, procedures).
- 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 an 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.
- 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 email@example.com .