Quality Control Laboratory Compliance Manager - Summerville, United States - Thorne Research Inc

Thorne Research Inc Summerville, United States

2 weeks ago

Description

Job Description

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:

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:

Competitive compensation
100% company-paid medical, dental, and vision insurance coverage
Company-paid short- and long-term disability insurance
Company- paid life insurance
401k plan with employer matching contributions up to 4%
Gym membership reimbursement
Monthly allowance of Thorne supplements
Paid time off, volunteer time off and holiday leave
Training, professional development, and career growth opportunities
A safe and clean work environment

A little bit more about us:

We are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. To do that, Thorne owns every step of its business, from R&D to product delivery and customer service. Currently, we are:

The only company with exclusive partnerships with the Mayo Clinic and U.S. Olympic teams.
The #1 prescribed practitioner brand to 30 to 40-year-olds.
The #2 most dispensed supplement brand.
The fastest growing supplement company with sales on Amazon; the #1 practitioner brand; with an average ranking of 4.42 of 5 stars.

If you want to make a difference in the lives of others consider becoming part of the Thorne team.

Must be able to safely work with ingredients and products that are derived from possibly allergenic sources including, but not limited to, nuts, soy, dairy, fish, and shellfish.

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.

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