Ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards for the Company
Requirements
- A bachelor’s degree or higher in a scientific field (chemistry, biology, or life science)
- 3-5 years of experience in Quality Assurance within a laboratory or regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)
- Must have experience working in a GMP facility
- ISO 17025:2017 accredited lab experience preferred
- Moderate understanding of microbiology and/or chemistry-related terms and testing
- Moderate understanding of USP/EP/JP standards and guidelines
- Moderate understanding of laboratory regulations (FDA, ISO, GLP, GMP)
Responsibilities
- Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements
- Maintain the internal auditing program to ensure the established techniques are followed and understood
- Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings
- Maintain the Management Review process
- Maintain the laboratory proficiency testing program
- Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train laboratory personnel, as needed to help reduce quality events
Other
- A bachelor’s degree or higher in a scientific field (chemistry, biology, or life science)
- Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills
- Strong organizational skills, and ability to multitask in a dynamic, fast-paced environment
- Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills
