Lab Technical Supervisor: GMP/GLP Process Leader

Threshold Enterprises; Scotts Valley (CA); On-site; USD 75,000 - 85,000; Full time

Job summary

Threshold Enterprises in Scotts Valley, CA is seeking a Technical Supervisor to lead and support laboratory functions including out of spec investigations, process improvements and technical writing (SOPs). You will collaborate with R&D, Compliance, and FDA-related projects to ensure data integrity and regulatory readiness.

The role requires a B.S. in a related field, 4+ years supervising lab teams, and deep knowledge of GMP/GLP, QA systems, and CAPA.

Qualifications

• Minimum: B.S. degree in Food Science, Food Safety, Chemistry, Microbiology, Biology or related technical field with 4 years of experience or equivalent.
• Demonstrated knowledge of quality systems such as GMP, GLP, HACCP, or ISO, including laboratory compliance, auditing, or microbiology.
• 4+ years of experience Supervising, Managing or Developing Others or project management skills.

Responsibilities

• Ensure QC lab compliance with GMP, GLP, and internal SOPs.
• Manage instrument qualification, calibration, and maintenance programs.
• Lead high impact research initiatives for the Scientific Board and collaborate with R&D teams to resolve complex technical challenges.
• Lead OOS/OOT investigations; implement CAPA and effectiveness checks.
• Support audits and regulatory inspections; prepare documentation and responses, especially for FDA, UL and Kaizen activities.
• Review and approve analytical data and Certificates of Analysis (CoAs).
• Review FDA reports and support LIMS operations.
• Run Safety & onboarding training; maintain records and retraining triggers.
• Lead LAII team for OSI process improvement, documentation, compliance.
• Redesign OSI program and oversee OOS/OOT investigations, trending.
• Facilitate MRB meetings and lead lab investigations for MRB items.
• Own/coordinate compliance, data integrity, and process optimization projects.
• Draft/update SOPs, work instructions, and controlled forms, coordinate approvals.
• Statistically analyze quality data and identify potential problem areas to prevent issues.

Skills

GMP/GLP knowledge

Quality systems

Lab supervision

CAPA investigations

SOP writing

LIMS experience

Data analysis

Education

B.S. in Life Sciences or related field

Job description

Threshold Enterprises in Scotts Valley, CA is seeking a Technical Supervisor to lead and support laboratory functions including out of spec investigations, process improvements and technical writing (SOPs). You will collaborate with R&D, Compliance, and FDA-related projects to ensure data integrity and regulatory readiness.

The role requires a B.S. in a related field, 4+ years supervising lab teams, and deep knowledge of GMP/GLP, QA systems, and CAPA.