Quality Control (QC) Laboratory Compliance Manager

At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. You’ll be joining a team of more than 700 passionate individuals committed to our cause of providing superior health solutions.

POSITION SUMMARY: : This position manages and supports the implementation of overall laboratory compliance including, but not limited to, GMP and data integrity programs for laboratory operations (sample receipt through sample disposition) and all laboratory systems as prescribed in Thorne’s policies and standard operating procedures. The QC Laboratory Compliance Manager works with QC Laboratory Management and Quality Assurance in activities to ensure that compliance is demonstrated to external regulators (FDA, TGA, NSF and other applicable agencies/organizations). This role is critical during regulatory audits/inspections for the execution of reviewing and producing timely objective evidence to show conformity to Thorne Quality Systems.

FLSA STATUS: Exempt

RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job

• Manages and leads activities to ensure that gaps in QC Laboratory procedures and practices are addressed as needed to be compliant with current and new/revised standards, regulations and policies.
• Manages the quality activities for laboratory compliance with cGMP, ISO 17025 and regulatory requirements including, but not limited to, method development, validation and verification, method transfer, method lifecycle management, instrument qualification, instrument software validation and lifecycle, reference standard program, and data integrity.
• Oversees the drafting of qualification/validation protocols and execution of protocols. Oversees the write-up of
  qualification and validation reports.
• Supports instrument laboratory software validation activities in the QC Laboratories.
• Ensures compliance with laboratory software testing and validation requirements.
• In conjunction with the QC Laboratory Manager, transfers methods from development to routine usage and ensures that methods are validated prior to transfer to routine analysis for use in releasing materials and finished goods.
• Performs periodic auditing of the laboratory systems (reference standards, chemicals, column management, etc).
• Performs and supports auditing of outside contract laboratories and oversees the qualification of labs, maintains the approved contract lab list and tests, and is responsible for the review and approval of the Quality Assurance Agreement.
• Monitors, trends and tracks QC laboratory metrics for Investigations (OOS), CAPAs, ETRs and other relevant quality
  systems to ensure their timely completion. Identifies trends in analytical and microbiological data.
• Actively participates in process improvement initiatives aiming for RFT on documentation and OOS/Deviation/NCM reduction in collaboration with Quality management.
• Responsible for escalation of OOS investigations within QC laboratory and will develop and implement long-term strategies and continuous improvements for QC Laboratory Compliance.
• Works with the QC Laboratory Manager in troubleshooting complex laboratory issues and demonstrates strong risk assessment skills and root cause analysis in support of ongoing laboratory investigations.
• Supports updates of QC Laboratory documents (SOPs, Wis, TMs), specifications (FPS and RMS) and LIMS requirements as needed. Oversees the review of stability protocols and reports.

What You Need:

• Bachelor’s degree (BS/BA) in chemistry, biochemistry, microbiology or related science discipline is required. An advanced degree is a plus.
• Prior supervisory and/or managerial experience in laboratory compliance in a cGMP or ISO laboratory environment is required.
• Prior experience in testing and release of chemicals/pharmaceuticals/dietary supplement products is desirable.

Physical Demands:

• Must be able to work in a stationary position for long periods of time as well as move about unassisted. Must be able to hear and converse with supervisors and other employees. Must be able to read large volumes of printed material. Must be able to work in a moderate noise level environment.

What We Offer:

A little bit more about us:

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

Thorne values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.