QC LAB COMPLIANCE SPECIALIST

Company: Thorne
Location: Summerville
Posted on: June 13, 2022

Job Description:

POSITION SUMMARY: Provides support for all compliance functions within the QC Laboratory. The role will work
with QC Lab Management and Quality Assurance in activities surrounding compliance to corporate policies,
demonstration of compliance internally through Management Review, and 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

RESPONSIBILITIES:

• Works with QC Laboratory Management and Quality Assurance 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.
  
• Coordinates QC Laboratory training with QC Laboratory Management.
  
• Writes and updates QC Laboratory documents (SOPs, WIs, TMs) and specifications (FPSs and RMSs) as needed.
  
• Collaborates with Laboratory Management to drive consistency of intradepartmental practices and consistency with
  GLP. This may require the use of discretionary decision-making and/or collaboration with QC Laboratory
  Management.
  
• Works with LIMS Administrator in ensuring changes and updates to QC Laboratory documents and procedures are
  updated in the LIMS.
  
• Participates in technical advisory roles as needed.
  
• Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing
  goals and finds innovative, well thought-out solutions to problems.
  
• Adheres to company safety requirements.
  
• Seeks formal and informal performance assessments, including performance versus expectations and goals, behaviors,
  and leadership potential.
  
• Actively participates in required training and development programs and electives as suits one's needs, and support
  colleagues, trainers, and management as appropriate with these efforts.
  
• Promotes the Company's Mission and Values, including an accountable, innovative, and results-oriented culture that
  promotes customer service, openness, teamwork, mutual trust, and respect.
  
  • What You Need:
    
    
    • Education and Experience: By training, education, and/or experience, must be able to perform the essential duties of
      the job.
      a. B.S. degree in chemistry or science-related field with a minimum of 12 hours credit in college chemistry is
      required. A minimum of 5 years of analytical laboratory experience is also required.
      b. Relevant analytical laboratory experience along with demonstrated aptitude for carrying out responsible
      technical assignmentsis desirable. Technical writing experience and experience in an FDA regulated
      environment is a plus.
      
    • 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.
          
          THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

Keywords: Thorne, Summerville , QC LAB COMPLIANCE SPECIALIST, Healthcare , Summerville, South Carolina