Manager of Quality Systems in Biologicals

2 weeks ago

Rogers, Arkansas, United States Pel-Freez, LLC Full time
Job Overview

POSITION SUMMARY:

The Biological Quality Assurance Manager plays a pivotal role in ensuring compliance with environmental and quality standards. This position involves conducting thorough research, analyzing critical data, leading the quality assurance initiatives, providing essential technical support, overseeing the Quality team, and fostering a culture of continuous improvement within the quality systems and standards of Pel-Freez, LLC.

KEY RESPONSIBILITIES:

  • Plan, coordinate, and oversee the quality assurance program for the Biologicals division to guarantee that products align with established standards.
  • Implement and promote quality systems, standards, inspection protocols, and testing methodologies.
  • Develop, execute, and assess quality reporting metrics while managing quality system challenges.
  • Offer technical support and guidance for product manufacturing, including documentation, process flow diagrams, and raw material specifications.
  • Ensure adherence to relevant regulations, including FDA and ISO standards.
  • Analyze data to identify root causes of issues and implement effective solutions.
  • Manage multiple tasks efficiently, demonstrating strong time management skills.
  • Champion the Quality System-Biologicals as part of the company's commitment to continuous improvement and compliance with policies and procedures.
  • Serve as the primary Management Representative for ISO and the company’s Quality System.
  • Engage in design development projects to advocate for Quality Systems.
  • Design, document, and implement methodologies for process control, enhancement, testing, and inspection.
  • Report on quality system challenges, trends, and losses to management.
  • Provide direction and support for the development and maintenance of internal Quality Systems.
  • Collaborate with the quality team on quality system issues.
  • Recruit, train, and manage the Quality team, overseeing promotions, transfers, and terminations.
  • Address product deficiencies, monitor corrective actions, and ensure timely and accurate communication with customers.
  • Assist or lead internal and external audits while providing quality assurance training.
  • Determine product disposition and evaluate retained, returned, and released products.
  • Review and ensure the accuracy of final release documents and customer complaints.
  • Verify product quality through daily control sheets and Quality shipping logs.
  • Guide laboratory personnel on quality and product/processes while supporting technical development activities.
  • Manage and control quality documentation and maintain accurate inventory related to product release.
  • Perform any other related duties as assigned.
  • Exhibit exemplary attendance and punctuality.

EDUCATION & EXPERIENCE:

  • A bachelor’s degree or higher in a scientific discipline or a related field is required.
  • Experience with quality principles and the interpretation and application of industry regulations (e.g., ISO 9001) is essential.

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Thorough understanding of scientific methods and laboratory processes, including testing and quality assurance protocols.
  • Extensive knowledge of industry standards, ISO programs, USDA regulations, and the company’s biological products and processes.
  • Exceptional communication and interpersonal skills, capable of effectively engaging with all organizational levels and external stakeholders.
  • Strong technical expertise in quality systems, inspection processes, and testing methodologies.
  • Proven ability to lead, supervise, and develop a team, including providing training and fostering a collaborative work environment.
  • Skilled in identifying issues, analyzing root causes, and implementing effective solutions to enhance processes and efficiency.
  • Ability to drive continuous improvement initiatives and modernize existing quality systems to meet market demands.
  • Demonstrated high ethical standards and integrity in all professional activities.
  • Capacity to make rational, objective, and fact-based decisions.
  • Meticulous attention to detail, ensuring accuracy and quality in all aspects of work.
  • Strong business acumen and understanding of the significance of quality management in supporting company profitability and customer satisfaction.
  • Ability to adapt to changing conditions and be flexible in optimizing and adjusting processes to meet evolving needs and customer feedback.

SUPERVISORY RESPONSIBILITIES:

The QA Manager for the Biologicals Division is responsible for supervising the Quality Team in inspection and testing procedures. This role requires frequent interaction with co-workers, management, and external stakeholders.

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