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 team is comprised of over 650 enthusiastic professionals who are committed to pushing the limits of health solutions.

ROLE SUMMARY: The Quality Assurance (QA) Specialist II plays a critical role in ensuring the integrity of our quality processes and operations. This position requires a comprehensive understanding of quality management principles and practices. The QA Specialist II will oversee the Change Control process, the Corrective and Preventive Action (CAPA) system, and manage nonconforming materials. Additionally, this role involves the qualification of suppliers, conducting internal and external audits, and collaborating with various departments to resolve product-related issues.

KEY RESPONSIBILITIES:

  • Establish and maintain effective relationships with external manufacturers, ensuring clear communication regarding quality requirements.
  • Conduct thorough audits of suppliers, including onsite evaluations of contract manufacturers and key suppliers.
  • Oversee the supplier qualification process, ensuring compliance with established procedures and standards.
  • Address and resolve supplier quality concerns through investigation and corrective action implementation.
  • Manage supplier quality agreements and maintain an updated list of approved suppliers.
  • Lead customer complaint investigations, providing detailed reports on findings and corrective actions.
  • Participate in meetings to address adverse events and coordinate investigations as necessary.
  • Review stability data and inform management of any potential issues.
  • Stay informed on Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs), adapting to changes as needed.
  • Initiate improvements to streamline quality processes and enhance operational efficiency.
  • Coordinate internal audits and inspections, ensuring thorough documentation and follow-up on findings.
  • Facilitate CAPA meetings and manage documentation through the EtQ system.
  • Evaluate raw materials to ensure alignment with specifications and identify quality risks.
  • Conduct Product Quality Reviews (PQR) for various product lines as required.
  • Perform mock recall exercises and prepare comprehensive reports for management.
  • Support regulatory audits by providing necessary documentation and assistance.
  • Maintain a high level of attention to detail in all tasks and documentation.
  • Engage in process improvement initiatives, ensuring proper documentation of enhancements.
  • Provide quality insights on new products and processes as needed.
  • Compile and present periodic quality reports to management.
  • Ensure compliance with all regulatory requirements, including cGMP and FDA standards.
  • Adhere to safety protocols within the workplace.

QUALIFICATIONS:

  • Bachelor's degree with a minimum of four years of relevant experience, or an equivalent combination of education and experience.
  • Ability to drive positive change and provide well-reasoned arguments regarding technical and supplier requirements.
  • Proficient in managing multiple projects and meeting deadlines in a fast-paced environment.
  • Excellent interpersonal skills and the ability to engage collaboratively with others.
  • Strong attention to detail and effective verbal and written communication skills.
  • Willingness to travel as required for supplier audits and inspections.

WHAT WE OFFER:

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

  • Competitive salary
  • Comprehensive medical, dental, and vision insurance
  • Company-paid disability and life insurance
  • 401k plan with employer matching
  • Gym membership reimbursement
  • Monthly allowance for Thorne supplements
  • Generous paid time off and holiday leave
  • Ongoing training and development opportunities
  • A safe and supportive 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 standards. We are proud to partner with esteemed organizations and maintain a leading position in the supplement industry.

Thorne is an equal opportunity employer, valuing diversity and inclusion in the workplace.



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