Quality Associate II

Thorne•Summerville, SC

14h•Onsite

About The Position

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. 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 at every age and life stage. The Quality Associate is responsible and accountable for various quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Manages product certification process and supports the following process: Change Control, Corrective and Preventive Action (CAPA) system, deviation process, customer complaints, nonconforming material process, and internal audit process. Coordinates with third party certifying bodies, internal resources, and outside contract manufacturers on product information and certification testing. Must be able to lead and work with cross-functional teams and track projects to completion.

Requirements

By training, education, and/or experience, must be able to perform the essential duties of their job.
Minimum of a high school diploma required.
Employee is able to read and understand at a highly technical and proficient level.
The employee follows instructions, both verbal and written, and communicates effectively with supervisors and fellow employees.
Employee can use the equipment and software required to accomplish the responsibilities of the position.
Ability to effect change in a positive environment.
Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.
Initiate and complete reports in a timely manner.
Work independently with little direction in a fast-paced environment.
Possesses good interpersonal skills and engages with others in a positive manner.
Schedule projects and meet tight deadlines.
Develop and deliver on assigned objectives within requested timeframes.
Possess strong attention to detail.
Possess strong verbal and written communication skills.
Raise issues and concerns promptly and offers pragmatic solutions for consideration.
Document and present work in a clear, accurate and concise manner.
Associates must be able to complete all tasks listed above with no assistance or guidance from others to advance to a Quality Associate II.

Nice To Haves

Preference of a college degree.

Responsibilities

Build a strong working relationship with third party certification entities and manage certification program.
Coordinate information between third party certification entities, internally at Thorne, and outside contract manufacturers to certify products.
Provide and maintain status reports.
Assist with customer complaint investigations as necessary.
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.
Manage the Deviation and the Nonconforming Material process through EtQ.
Support the stability program by coordinating sample submission to the lab for internal and/or external testing.
In addition, coordinate meetings and approvals for review of stability data.
Create and compile stability data results and final reports.
Proactively initiate the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.
Participate in internal audits and inspections of various departments/processes.
Write, revise, and review SOPs, controlled forms, and related documents to ensure best practices and current operations.
Demonstrate knowledge of department procedures and company policies, pay attention to detail in all aspects, and complete all paperwork accurately, neatly, and fully.
Participate on process improvement teams to provide quality input and direction.
Ensure that documentation of improvements is completed and approved as needed.
Provide quality review and feedback on new products and processes.
Provide ongoing support to all employees on quality system requirements and problem solving.
Compile and create monthly KPI reports and/or periodic reports for management.
Complete ERP functions as related to the NCM process.
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.
Promote the Company’s Mission and Values, including an accountable, innovative, and results-oriented culture promoting customer service, openness, teamwork, mutual trust and respect.
Actively participate in all required training and development programs and electives as may suit one’s needs, and support colleagues, trainers, and management as appropriate with these efforts.
Ability to be available for other duties as assigned.
Seek formal and informal performance assessments of self, including performance versus expectations and goals, behaviors, and leadership potential.