Quality Assurance Manager - Healthcare jobs in Charleston, SC

We are looking for top of market talent to help grow and innovate our company. If you are someone who embraces challenge, fosters innovation, and desires to make a difference in the world, then let’s talk.

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. As a self-motivated Production Lead you’ll be joining a team of more than 650 passionate individuals committed to our cause of providing superior health solutions.

POSITION SUMMARY: The Quality Assurance (QA) QMS Specialist is responsible and accountable for completing quality related tasks in ETQ. The QA QMS Specialist is responsible for quality tasks related to active ETQ modules which include but not limited to: Change Management, Document Control, Quality Records, Corrective Action (CAPA), Deviations, Nonconforming Material, Assets, Calibration and Maintenance, Employee Training, and Complaints Handling. 

RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job. 

• Knowledgeable of and follows the applicable provisions of the QA department’s standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMPs). Remains knowledgeable on an ongoing and timely basis as changes in the SOPs and cGMPs occur. 
• Knows and follows the Quality department policies and procedures and Thorne Research policies and procedures as outlined in Thorne Research’s Employee Handbook. 
• Gets along with co-workers and supervisors. Responds appropriately to criticism and instructions from supervisors. Follows the Standards of Conduct as outlined in the most current version of Thorne Research’s Employee Handbook. 
• Takes initiative to make sound decisions within the guidelines provided, is consistent in their work, and sees projects through to a satisfactory end without supervision. 
• Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and finding innovative, well thought-out solutions to problems.
• Seeks formal and informal performance assessments of self, including performance versus expectations and goals, behaviors, and leadership potential. 
• Promotes the Company’s Mission and Values, including an accountable, innovative, and results-oriented culture promoting customer service, openness, teamwork, mutual trust, and respect.
• Receives, routes, and tracks Change Records through the Quality Management System. Implements approved changes and maintains the Change Records through the Quality Management System 
• Creates, formats, edits, routes, finalizes, files, and maintains all controlled documents within the Quality Management System. Coordinates with Subject Matter Experts (SMEs) to ensure document accuracy. 
• Ensures periodic document reviews are conducted per allotted time frames. 
• Provides support in answering questions about Quality Management System processes relating to Change Management and Document Control. 
• Troubleshoots and provides solutions to issues during the change management process.
• Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are released.
• Ensures all tasks for finalization of controlled documents are completed (SOPs, forms, WI, policies) in the Quality Management System. 
• Coordinates with various departments within the organization to understand needs, requirements, and actively participates in the development, testing and deployment of solutions. 
• Partners with Human Resources, Organizational Development, and Information Technology departments on employee’s quality system access, training, and password resets. 
• Assists in the gathering and analysis of requirements, demonstrations, execution, implementation, validation testing, and training of quality management systems. 
• Assists in the creation of project documentations, such as: Requirements, Configuration, Testing, and Validation material. 
• Updates and completes steps in all relevant product checklists and routes to respective personnel for implementation and completion.

What You Need: 

• Experience and/or Education: By training, education and/or experience, employee must be able to perform the essential duties of the job. High school diploma or general education degree (GED) is required. 3 years of Business/Technical analyst experience in a FDA regulated environment manufacturing environment, 2-3 years of experience in document control and/or configuration management systems. 
•  Experience in a FDA regulated environment and familiarization with Quality Management processes, systems and terminology preferred. 
•  Experience with software development life cycle 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. 

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.

**This is a Non-Exempt (hourly) position**

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.