Overview
Quality Assurance Compliance Specialist Jobs in Los Angeles, CA at BioTrace Labs
Title: Quality Assurance Compliance Specialist
Company: BioTrace Labs
Location: Los Angeles, CA
About BioTrace Scientific
BioTrace Scientific Inc is a new analytical testing laboratory launching in North Hollywood, California. We are building a state-of-the-art ISO/IEC 17025 laboratory from the ground up, specializing in the analytical testing of dietary supplements, nutraceuticals, and botanical raw materials. This is a rare opportunity to join a small, motivated team at the very beginning and help shape the Quality function as the laboratory scales.
About the Role
The Quality Assurance & Quality Control Specialist is responsible for upholding the integrity, compliance, and technical accuracy of laboratory activities at BioTrace Scientific Inc. The role combines hands-on review of analytical data — including chromatographic and mass spectrometric data, calibration curves, reference standard documentation, and laboratory QC reports — with ownership of the laboratory's Quality Management System, internal audit program, nonconformance management, and personnel training. This position supports the ISO/IEC 17025 accreditation process and ensures alignment with 21 CFR Part 111 (Dietary Supplement cGMP).
Key Responsibilities
- Perform secondary review of analytical data packages, including chromatographic (HPLC, HPTLC, GC) and mass spectrometric (LC-MS/MS, GC-MS/MS, ICP-MS) data, calibration curves, peak integration, system suitability, and quantitative calculations
- Review laboratory QC reports, control charts, and instrument performance data to verify methods remain within acceptance criteria
- Verify reference standard documentation, including certificates of analysis, lot traceability, expiration dates, and proper storage of standards and reagents
- Prepare, review, and approve Certificates of Analysis (CoAs) prior to release to customers
- Identify out-of-specification (OOS), out-of-trend (OOT), and anomalous results and initiate investigations as appropriate
- Maintain and continuously improve the laboratory's QMS in alignment with ISO/IEC 17025 and 21 CFR Part 111
- Author, review, and revise SOPs, work instructions, forms, and quality records under controlled documentation procedures
- Maintain the Master Document Register, including version control, periodic review, and document retirement workflows
- Plan and conduct internal audits across laboratory functions and track findings through to closure
- Support ISO/IEC 17025 accreditation activities including application, assessment, and ongoing maintenance
- Investigate and document nonconformances, deviations, and OOS/OOT results, leading structured root cause analyses using tools such as 5-Why and Fishbone diagrams
- Track Corrective and Preventive Actions (CAPA) through to closure and verify effectiveness
- Develop and maintain personnel training programs, competency assessments, qualification records, and onboarding documentation
- Review incoming sample submissions for completeness — verify batch numbers, lot numbers, sample size, container integrity, and customer specifications
- Communicate professionally with customer QA contacts regarding sample documentation, specifications, and test results
Required Qualifications
- Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Microbiology, or related scientific field
- Minimum 2+ years of Quality Assurance or Quality Control experience in a regulated analytical laboratory (food, dietary supplement, pharmaceutical, or nutraceutical industry)
- Demonstrated ability to read, interpret, and critically review chromatographic and mass spectrometric data
- Working knowledge of ISO/IEC 17025 and 21 CFR Part 111
- Experience with internal audits, deviation investigations, CAPA systems, and SOP authorship
- Strong attention to detail with the ability to identify discrepancies in raw data, calculations, and documentation
- Excellent written and verbal communication skills
- Proficiency in Microsoft Office (Excel, Word, Adobe Acrobat) and LIMS
Preferred Qualifications
- Hands-on familiarity with chromatography data systems (e.g., Agilent OpenLab CDS, Empower, Chromeleon, MassHunter, Simplicity 3Q, or similar)
- Direct experience supporting an ISO/IEC 17025 accreditation, application, or maintenance cycle
- Familiarity with USP, AOAC, and AHP compendial methods and acceptance criteria
- Experience with structured root cause analysis tools (5-Why, Fishbone, Fault Tree Analysis)
- Experience supporting FDA or third-party accreditation audits
Additional Requirements
- Ability to work full-time on-site at the North Hollywood laboratory
- Strong organizational and time management skills
- Ability to manage multiple priorities and meet deadlines
- US work authorization
What We Offer
- Hourly rate: $28.00 – $38.00 per hour
- Overtime pay per California labor law
- Paid time off and holidays
- Opportunity to grow with a new laboratory and shape the Quality function from the ground up
