Quality Assurance Analyst II

1 week ago

Summerville, South Carolina, United States Thorne Research Inc Full time
Position Overview

At Thorne Research Inc, we are dedicated to enhancing the health and well-being of individuals through our innovative products. Our mission is to empower people to achieve optimal health every day. As a Quality Assurance Specialist II, you will be an integral part of a dynamic team focused on delivering superior health solutions.

Role Summary: The Quality Assurance (QA) Specialist II is tasked with overseeing quality-related operations and ensuring compliance with industry standards. This role requires a comprehensive understanding of quality management principles and practices. Responsibilities include supporting the Change Control process, managing the Corrective and Preventive Action (CAPA) system, and overseeing the nonconforming material process. You will also be involved in supplier qualification, internal audits, and third-party audits.

Key Responsibilities:

  • Develop and maintain effective relationships with external manufacturers, ensuring clear communication regarding quality requirements.
  • Collaborate with cross-functional teams, including purchasing, engineering, and sales, to uphold supply chain integrity.
  • Conduct thorough audits of suppliers, including on-site evaluations of contract manufacturers.
  • Oversee the supplier qualification process, ensuring all suppliers meet established criteria before procurement.
  • Address and resolve supplier quality issues through detailed investigations and corrective actions.
  • Maintain supplier quality agreements and an updated approved supplier list in conjunction with procurement.
  • Lead customer complaint investigations, documenting findings and communicating necessary actions to relevant stakeholders.
  • Participate in Adverse Event board meetings to facilitate investigations when required.
  • Manage the stability program by analyzing stability data and reporting any anomalies to management.
  • Stay informed about Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs), adapting to procedural changes proactively.
  • Initiate and implement streamlined systems to identify and address quality issues effectively.
  • Coordinate internal audits and inspections, ensuring thorough planning, execution, and follow-up on findings.
  • Facilitate CAPA meetings and oversee documentation processes through EtQ, providing support for root cause analysis and corrective action development.
  • Evaluate raw materials to ensure alignment with specifications and identify potential quality risks.
  • Conduct Product Quality Reviews (PQR) for designated products as needed.
  • Execute mock recall exercises and compile comprehensive reports for quality management.
  • Assist during regulatory audits by documenting processes and gathering necessary documentation.
  • Review and revise SOPs and related documents to ensure alignment with best practices.
  • Engage in process improvement initiatives, providing quality insights and ensuring documentation of enhancements.
  • Offer ongoing support to employees regarding quality system requirements and problem-solving strategies.
  • Prepare and present periodic reports for management review.
  • Ensure compliance with cGMP, FDA, OSHA, and other regulatory standards as per company policy.
  • Adhere to all safety protocols established by the company.

Qualifications:

  • Bachelor's degree coupled with four years of relevant experience, or an equivalent combination of education and experience.
  • Proven ability to drive positive change and provide sound justification for technical and supplier requirements.
  • Strong organizational skills with the ability to manage multiple projects and meet deadlines.
  • Willingness to travel as required for supplier audits and evaluations.
  • Excellent interpersonal skills and a collaborative approach to working with others.
  • Meticulous attention to detail and strong verbal and written communication abilities.
  • Proactive in raising issues and proposing practical solutions.
  • Ability to document and present work clearly and concisely.

What We Offer:

Thorne Research Inc provides a supportive work environment with opportunities for professional growth. Our comprehensive benefits package includes:

  • Competitive salary
  • Comprehensive medical, dental, and vision insurance
  • Short- and long-term disability insurance
  • Life insurance coverage
  • 401k plan with employer matching
  • Gym membership reimbursement
  • Monthly allowance for Thorne supplements
  • Generous paid time off and holiday leave
  • Training and professional development opportunities
  • A safe and clean workplace

About Us:

Thorne Research Inc is committed to delivering personalized health solutions and superior supplements. We manage every aspect of our business, from research and development to customer service, ensuring the highest quality products for our customers.

Thorne is an equal opportunity employer. We value diversity and are dedicated to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any protected characteristic.

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