POSITION SUMMARY: The Quality Assurance (QA) Specialist II is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Supports
Change Control process, Corrective and Preventive Action (CAPA) system, nonconforming material process, supplier qualification process, internal audit process and third-party audit process. Schedules, coordinates, and conducts audits of suppliers including, but not limited to, contract manufacturers and raw material suppliers. Works with the Material Review Board, Purchasing, and Suppliers to resolve product issues. Coordinates and manages relationships with outside contract manufacturers. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in a cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.
FLSA STATUS: The U.S. Fair Labor Standards Act (FLSA) requires employers to classify their employees as being either exempt or non-exempt for the purpose of being paid overtime wages. The essential duties of this job are such that
the employee is classified according to the FLSA as an EXEMPT employee.
TRAVEL REQUIREMENTS: Minimal (<5%) to Extensive (>50%)
To perform the job successfully, the employee must be able to perform each essential duty of the job in a satisfactory manner, with or without a reasonable accommodation. The essential duties of the job include the Responsibilities,
Competencies, Experience, Proficiencies, Physical Demands, and Desired Leadership Behaviors outlined below.
RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.
- Manage working relationships with all Thorne Research outside manufacturers. Coordinate with contract
manufacturers to ensure adequate communication on requirements.
- Build a strong working relationship with purchasing, engineering, quality, planning, research and development, and
the sales team when dealing with requirements for contract manufacturing and supply chain integrity.
- Coordinate and perform auditing of suppliers. Including onsite audits of contract manufacturers and other key
suppliers.
- Manage supplier qualification process ensuring procedures are executed accordingly and all suppliers are approved
prior to purchasing from them.
- Coordination and resolution of supplier quality issues. Includes investigation, resolution, follow-up and corrective
actions.
- Coordinate and maintain supplier quality agreements.
- In conjunction with procurement, maintain approved supplier listing.
- Responsible for approval and disapproval of suppliers.
- Initiate and complete customer complaint investigations. Communicate complaint investigation details, root cause,
and CAPAs (when applicable) to appropriate parties.
- Participate in Adverse Event board meetings to coordinate investigation of Adverse Events requiring when applicable
- Oversee the stability program by reviewing stability data on normal and accelerated studies. Inform Quality
Management and stakeholders of any anomalies or potential stability issues.
- Become thoroughly knowledgeable of the applicable portions of Standard Operating Procedures (SOPs) and Good
Manufacturing Practices (GMPs) and maintain knowledge base on an ongoing, timely basis as procedural changes
occur without relying on management intervention or direction.
- 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. Provide support and lead 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. Identify any quality risks and communicate to Purchasing, R&D, 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.
- Write, revise, and review SOPs, controlled forms and related documents as needed to ensure best practices and current
operations. Review and approve documents through the change control process.
- Demonstrate knowledge of department procedures and company policies, pay attention to detail in all aspects, and
complete all paperwork accurately, neatly, and fully.
- Participate in process improvement teams to provide quality input and direction. Ensure that documentation of
improvements are 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 GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company
policy.
- Adhere to company safety requirements.
- Demonstrate initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing
goals and finds innovative, well thought-out solutions to problems.
- Take initiative and makes sound decisions within the guidelines provided, and is willing, if necessary, to
stop a procedure or process when SOP or product quality is in question.
- Other duties as may be assigned.
What You Need:
- By training, education, and/or experience, must be able to perform the essential duties of
their job. 4-year college degree with four to eight years related experience; or equivalent combination of education
and experience.
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
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Schedule:
- 10 hour shift
- 8 hour shift
Work setting:
Education:
Experience:
- Quality assurance: 4 years (Required)
- FDA regulations: 4 years (Required)
Work Location: In person