Quality Assurance Specialist II

11 hours ago

Summerville, South Carolina, United States Thorne Research Inc Full time
Job Title: Quality Assurance Specialist II

Thorne Research Inc is seeking a highly skilled Quality Assurance Specialist II to join our team. As a Quality Assurance Specialist II, you will be responsible for ensuring the quality of our products and processes, and for maintaining compliance with regulatory requirements.

Key Responsibilities:
  • Manage working relationships with outside manufacturers and suppliers to ensure quality and compliance.
  • Coordinate and perform audits of suppliers, including onsite audits of contract manufacturers and other key suppliers.
  • Manage the supplier qualification process, ensuring procedures are executed accordingly and all suppliers are approved prior to purchasing from them.
  • Coordinate and resolve supplier quality issues, including investigation, resolution, follow-up, and corrective actions.
  • Coordinate and maintain supplier quality agreements.
  • Responsible for approval and disapproval of suppliers.
  • Initiate and complete customer complaint investigations, communicating details, root cause, and CAPAs (when applicable) to appropriate parties.
  • Participate in Adverse Event board meetings to coordinate investigation of Adverse Events when applicable.
  • Oversee the stability program, reviewing stability data on normal and accelerated studies, and informing Quality Management and stakeholders of any anomalies or potential stability issues.
  • Become thoroughly knowledgeable of applicable portions of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs), and maintain knowledge base on an ongoing, timely basis.
  • Proactively initiate the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.
  • Coordinate and participate in internal audits and inspections of various departments/processes, including planning of audits, execution, preparation and communication of audit reports, and follow-up on audit findings.
  • Coordinate CAPA meetings and oversee CAPA documentation through EtQ, providing support and leading when necessary, root cause analysis, and development of corrective and preventive actions.
  • Conduct raw material evaluations to provide feedback on alignment between supplier's specification and Thorne's specification, identifying any quality risks and communicating to Purchasing, Medical, and Engineering as necessary.
  • Conduct Product Quality Reviews (PQR) for Australia products and for Thorne core products as directed.
  • Conduct mock recall exercise and provide a final report to Quality management.
  • Provide support during regulatory audits through note taking and serving as a runner to gather required documents, writing, revising, and reviewing SOPs, controlled forms and related documents as needed to ensure best practices and current operations.
  • Demonstrate knowledge of department procedures and company policies, paying attention to detail in all aspects, and completing all paperwork accurately, neatly, and fully.
  • Participate on process improvement teams to provide quality input and direction, ensuring that documentation of improvements is completed and approved as needed.
  • Provide quality review and feedback on new products and processes as required.
  • Provide ongoing support to all employees on quality system requirements and problem solving.
  • Compile and create periodic reports for management.
  • Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
  • Adhere to company safety requirements.
Requirements:
  • Bachelor's degree with four years of related experience; or equivalent combination of education and experience.
  • Ability to effect change in a positive environment, providing constructive arguments and sound justification as it pertains to technical and supplier requirements.
  • Initiates and completes reports in a timely manner.
  • Works independently with little direction or oversight, in a fast-paced environment.
  • Schedules projects and meets tight deadlines.
  • Ability to travel more than 50% of time.
  • Develops and delivers on assigned objectives within requested timeframes.
  • Possesses good interpersonal skills and engages others in a positive manner.
  • Possesses strong attention to detail.
  • Possesses strong verbal and written communication skills.
  • Raises issues and concerns promptly and offers pragmatic solutions for consideration.
  • Documents and presents work in a clear, accurate, and concise manner.
What We Offer:

At Thorne Research Inc, 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, including:

  • 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

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.

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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