Lab Quality Manager (ISO 17025)
$90kTruSource Lab
Laboratory Quality Manager (ISO 17025)
Compensation: Starting at $90,000 annually; compensation commensurate with experience and qualifications.
About TruSource Analytics Laboratory
TruSource is an independent analytical testing laboratory currently preparing for launch and focused on scientific verification, transparency, and product authentication. We provide third-party testing services for nutraceuticals, dietary supplements, and specialty compounds through rigorous analytical science and quality-driven processes.
As part of its growth strategy, TruSource is expanding its analytical capabilities to support the rapidly growing longevity and research sectors, including specialized testing programs for research-use-only (RUO) peptides and related compounds. We are seeking an experienced Laboratory Quality Manager (LQM) to play a foundational role in laboratory launch, quality system implementation, and long-term compliance leadership.
Position Summary
The Laboratory Quality Manager serves as the primary quality and compliance leader supporting both existing analytical laboratory operations and the launch of TruSource Analytics Laboratory.
This hands-on leadership role is responsible for developing, implementing, and maintaining the laboratory quality systems, including SOPs, training programs, document control, chain-of-custody procedures, CAPA processes, quality investigations, laboratory information management workflows, and compliance activities.
The Laboratory Quality Manager will oversee quality systems supporting sample intake, analytical testing, data integrity, reporting workflows, and customer-facing quality documentation. The role includes supervision and development of laboratory personnel and support of day-to-day laboratory operations across multiple analytical testing programs.
During the initial launch phase, the Laboratory Quality Manager will also support accreditation-related initiatives in collaboration with external consultants.
Key Responsibilities
- Lead implementation and ongoing management of the laboratory Quality Management System (QMS).
- Develop, maintain, and control SOPs, Quality Manuals, training records, and quality documentation.
- Manage CAPA, deviations, investigations, change control, and document control processes.
- Develop, implement, and maintain procedures governing sample receipt, accessioning, chain-of-custody, sample traceability, storage, retention, disposition, and data integrity throughout the sample lifecycle.
- Support analytical method validation and laboratory quality oversight.
- Support quality review of analytical data, chromatograms, calculations, validation reports, and laboratory records to ensure scientific accuracy and defensibility.
- Review and approve laboratory reports, Certificates of Analysis (COAs), and related quality documentation while maintaining quality controls for report generation, approval, and release.
- Monitor equipment maintenance, calibration schedules, and laboratory readiness.
- Support testing operations utilizing HPLC, UPLC, LC-MS/MS, HPTLC, ICP-MS, and related analytical instrumentation.
- Support implementation and ongoing management of laboratory workflow systems, sample tracking processes, and digital quality records.
- Recruit, train, supervise, and develop laboratory analysts and technical staff.
- Conduct performance evaluations, identify training needs, and facilitate professional
- development opportunities for laboratory staff.
Technical Knowledge
- Analytical chemistry quality systems
- Method validation and verification
- HPLC, LC-MS/MS, HPLC-UV, ICP-MS, or related analytical techniques
- Chain-of-custody and laboratory data integrity controls
- Root cause analysis and quality investigations
- Laboratory documentation and records management
Education
- Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
Experience
- 5+ years of laboratory quality, regulatory, or analytical chemistry experience
- 3+ years in a quality leadership or laboratory management role
- Direct experience with ISO 17025 quality systems and accreditation
- Experience developing and managing SOPs, quality manuals, CAPA systems, and validation programs
- Experience managing quality programs within analytical testing laboratories.
- Ideally would have experience in using a variety of laboratory
- equipment, including Waters UPLC, Shimadzu LCMS, and Camag TLC
Preferred Qualifications
- Advanced degree (MS or PhD) in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline
- Experience with peptide testing, pharmaceutical analysis, nutraceutical testing, or contract laboratory operations
- Experience managing ISO 17025 accreditation projects
- Experience interacting with A2LA or comparable accreditation organizations
- Experience within regulated laboratory environments
- UPLC: 2 years (Preferred)
- ICP-MS: 2 years (Preferred)
- HPTLC: 2 years (Preferred)
Skills
- Strong knowledge of ISO 17025 quality systems, laboratory compliance, and quality management principles.
- Experience developing and maintaining Quality Manuals, SOPs, CAPA systems, and controlled documentation.
- Understanding of analytical laboratory operations, method validation, data integrity, and laboratory quality controls.
- Experience conducting audits, managing corrective actions, and leading continuous improvement initiatives.
- Strong problem-solving, organizational, and project management skills.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with laboratory personnel, consultants, and leadership.
- High attention to detail and commitment to scientific integrity.
Schedule
- Full time, 8 hours Monday - Friday, onsite
Benefits
- Health Insurance
- Paid Time Off (PTO)
Why Join This Opportunity
This is a unique opportunity to play a leadership role across both an established analytical laboratory environment and the launch of TruSource Analytics Laboratory.
- Work alongside experienced scientific, operational, and executive leadership.
- Lead quality and compliance programs across nutraceutical, dietary supplement, and emerging peptide testing services.
- Contribute to the development of innovative testing programs within the rapidly growing longevity and research sectors.
- Make a meaningful impact on transparency, scientific integrity, and consumer trust through independent analytical verification.
Application Question
What is your expected salary for this position?
If you are qualified and passionate about the opportunity, please apply via LinkedIn or submit your resume to Hayley Veal at ***email_hidden***.
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