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Director, Quality Assurance

Company: Thorne
Location: Summerville
Posted on: November 22, 2021

Job Description:

POSITION SUMMARY: The Director, Quality Assurance (QA) is responsible and accountable for all aspects of document control and Quality Control (QC) inspection. Provides general supervisory support to the QA, Product Data, and QC Inspection departments in a cGMP manufacturing environment. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Manages and supports the Material and finished Goods Release process, Document Control process, Change Control process, Corrective and Preventive Action (CAPA) system, deviation process, nonconforming material process, calibration, supplier qualification process and internal audit process. 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. * Becomes 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. * Provides project direction, coaching and mentoring for company personnel. Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities. * Leads, manages, and establishes quality department objectives, goals, and plans. * Demonstrates knowledge of department procedures and company polices, pays attention to detail in all aspects, and completes all paperwork accurately, neatly, and fully. * Ensures that QA/QC personnel are trained in applicable procedures. Ensures training is reasonably continuous, timely, and conducted before employee begins new tasks. * Verifies compliance for investigations and status of customer complaints. * Verifies compliance of quality systems and processes. * Provides and supports training of personnel. Ensures that cGMP training is completed annually. Provides ongoing support to all employees on quality system requirements and problem solving. Responsible for ensuring that training is complete on all new and revised procedures prior to implementation. * Oversees and manages cGMP training for all company employees. * Coordinates and participates in internal audits of various departments/processes including planning of audits, execution, preparation and communication of audit reports, and follow-up on audit findings. * Ensures that performance appraisals for direct reports and department personnel are conducted in a thorough and timely manner. * Oversees the approval or rejection of all components, product containers, closures, in-coming and /or in-process materials, packaging materials, labeling and finished products, including out-sourcing products, based on conformance to established specifications. * Oversees QA Document Control activities including processing of change requests, updates to bills of materials, manufacturing records, and other documents, and maintenance of product master and history files, validation files, and QA electronic databases. * Responsible for approval of procedures, specifications, forms, work instructions, and any other controlled documentation. Ensures documents meet cGMP requirements. * Oversees QC Inspection activities including the sampling, inspection, testing, and examination of components, mixtures, in-process materials, finished product and production areas. * Writes and revises SOPs and controlled forms and related documents to ensure best practices and current operations. * Reviews cGMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, stability studies, validation protocols and reports, deviation and investigation reports, labels, product specifications, monographs and other documentation. * Responsible for deviation review, CAPA, associated change control, change implementation and final corrective action review. * Leads the Corrective and Preventive Action (CAPA) team. Works with CAPA team members to determine root cause and develop action plans. Follow up on action plan implementation to ensure plans are effective and timely closure. * Responsible for ensuring the maintenance of applicable quality system tracking logs including, but not limited to, deviation, CAPA, nonconforming material, customer complaints, document control, and change control. Responsible for the maintenance of quality records. * Addresses observations or recommendations as well as implements corrective/preventive actions as needed. * Serves as a member of the audit team during external audits and inspections in accordance with applicable procedures. * Serves as a member of the Material Review Board and has final approving authority for material dispositions. * Coordinates and ensures maintenance of third-party quality certifications, as required. * Participates in process improvement teams to provide quality input and direction. Ensures that documentation of improvements are completed and approved as needed. * Coordinates the completion of periodic product reviews when required. * Oversees the implementation and maintenance of an automated electronic Quality Management System * Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy. * Adheres to company safety requirements. Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations. What You Need: By training, education, and/or experience, must be able to perform the essential duties of their job. 5+ years supervisory experience required. 4-year college degree in related field with four to eight years related experience is required. 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

Keywords: Thorne, Summerville , Director, Quality Assurance, Executive , Summerville, South Carolina

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