Quality Specialist I, cGMP Lab Testing
Overview
You own final approval and release of cGMP test results for biological samples at Creative Testing Solutions. You apply quality methodologies to ensure every batch meets FDA and CLIA standards before it reaches lab customers. You work with a team of quality specialists and lab personnel in Charlotte, NC. This role offers direct impact on patient safety and a clear path to Quality Specialist II and III.
What You'll Do10
- 1Review and approve quality control verifications for routine testing of biological samples, ensuring cGMP conformance before releasing results.
- 2Verify source data meets quality attributes and cGMP regulations, then approve final test results for laboratory customers.
- 3Maintain accurate records and documentation per good documentation practices, protecting donor, patient, and employee confidentiality.
- 4Support archival record organization and classification to preserve compliance and audit readiness.
- 5Ensure standard operating procedures (SOPs) are followed, resolving routine problems by escalations as needed.
- 6Analyze environmental monitoring data, investigating temperature and humidity issues within the lab.
- 7Review equipment re-qualifications and release instrumentation back into production, confirming acceptance criteria.
- 8Review and approve lab equipment calibrations and critical testing reagents for production use.
- 9Assist with lot changes, pack and ship supplies or specimens, and participate in performance improvement teams.
- 10Support internal audits, CAPA investigations, and data collection for un-assayed control lots.
Requirements10
- 1Bachelor's degree required; science degree preferred (biology, chemistry, or related).
- 20-2 years experience in cGMP regulated environment required for Level I.
- 32+ years for Level II; 4+ years for Level III with training experience.
- 4State licensure or certificate where applicable required.
- 5Strong critical thinking and problem-solving skills.
- 6Proficient in Windows and computer operations.
- 7Ability to work in a team and follow precise written and verbal instructions.
- 8Exposure to biological fluids, extreme cold (-20°C), and production chemicals; use of PPE required.
- 9Physical: standing, sitting, lifting up to 40 lbs, and fine motor skills.
- 10Shift: Tuesday to Saturday, 7:00 AM - 3:30 PM.
Salary Insight
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