QUALITY ASSURANCE 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.
At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions.
POSITION SUMMARY:


The Manager, Quality Assurance (QA) is responsible and accountable for all aspects of cGMP compliance and quality systems in relation to QA Document Control (QADC), Quality Associate, and Quality Specialist positions.
Provides general supervisory support to quality personnel in a cGMP manufacturing environment.
Possesses and applies a broad knowledge of Quality principles, practices, and procedures.
Manages and supports a variety of processes including material and Finished Goods Release process, Document Control process, Change Control process, and investigations.
Must be able to lead and work with cross-functional teams and track projects to completion.
Requires experience in cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures
RESPONSIBILITIES
• Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.
Become thoroughly knowledgeable of the applicable portions of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) and maintain knowledge base on an ongoing, timely basis as procedural changes occur without relying on management intervention or direction.
Provide project direction, coaching and mentoring for company personnel.
Proactively initiate the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.
Demonstrate knowledge of and teach department procedures and company polices, pay attention to detail in all aspects, and complete all paperwork accurately, neatly, and fully.
Supervise QA Document Control, QA Associate, and QA Specialist personnel.
Develop and train QA personnel in applicable procedures and processes.
Ensure training is reasonably continuous, timely, and conducted before employee begins new tasks.
Participate in internal audits and inspections of various departments/processes including execution, preparation and communication of audit reports, and follow-up on audit findings.
Oversee QA Document Control activities including processing of change requests, manufacturing records, and other documents.
Acts as an Authorized Person to certify that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorization and any other regulations relevant to the production, control and release of medicinal products
Write and revise SOPs and controlled forms and related documents to ensure best practices and current operations.
Responsible for overseeing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
Addresses observations or recommendations as well as implement corrective/preventive actions as needed.
Responsible for ensuring the maintenance of applicable quality system tracking logs.
Participate in process improvement teams to provide quality input and direction.
Ensure that documentation of improvements is completed and approved as needed.
Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements in accordance with company policy.
Adhere to company safety requirements.
Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
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 make 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.
Ability to effect change in a positive environment.
Must be able to provide constructive arguments and sound justification as it pertains to technical and compliant requirements when QA decisions are required.
What You Need:


Experience and Education:


Education and Experience:
By training, education, and/or experience, must be able to perform the essential duties of their job.
Supervisory experience required.
4+ years college degree with six years related experience in a cGMP regulated environment; or equivalent combination of education and experience.
Food or pharmaceutical experience preferred.

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.
Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer.
As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life.
Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy.
Thorne is the only supplement manufacturer that collaborates with Mayo Clinic on health and wellness research and content and is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S.
National Teams, and more than five million consumers.
For more information, visit Thorne.com
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