Quality Control Manager for Biological Products

2 weeks ago

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

POSITION SUMMARY:

The Biological Quality Assurance Manager plays a crucial role in maintaining environmental and quality standards by performing research, analyzing data, leading the quality assurance initiatives, offering technical assistance, overseeing the Quality team, and fostering continuous enhancement within the organization's quality frameworks and protocols.

KEY RESPONSIBILITIES:

  • Organize, manage, and oversee the quality assurance initiatives (Biologicals division) to guarantee that products comply with defined standards.
  • Implement and uphold quality systems, standards, inspection methodologies, and testing protocols.
  • Develop, execute, and evaluate quality reporting metrics and address quality system challenges.
  • Provide technical assistance and direction 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 execute corrective actions.
  • Effectively manage multiple tasks with strong time management capabilities.
  • Promote and support the Quality System-Biologicals as part of the organization’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 strategies for process control, enhancement, testing, and inspection.
  • Report on quality system challenges, trends, and losses to management.
  • Guide and support internal Quality System development and maintenance.
  • Collaborate with the quality team on quality system issues.
  • Recruit, train, and manage the Quality team, including overseeing promotions, demotions, transfers, and terminations.
  • Address product deficiencies, monitor corrective actions, and ensure timely and accurate communication with customers.
  • Assist or lead internal and external audits and provide quality assurance training.
  • Determine product disposition and assess retained, returned, and released products.
  • Review and verify the accuracy of final release documents and customer complaints.
  • Ensure product quality through daily control sheets and Quality shipping logs.
  • Guide laboratory personnel on quality and product/processes and support technical development initiatives.
  • Manage and oversee 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 required.

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Thorough understanding of scientific methods and laboratory processes, including testing and quality assurance procedures.
  • 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 levels of the organization and external stakeholders.
  • Strong technical expertise in quality systems, inspection methodologies, and testing protocols.
  • 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 improve efficiency.
  • Ability to drive continuous improvement initiatives and modernize existing quality systems, ensuring the organization remains responsive to market demands.
  • Demonstrated high ethical standards and integrity in all professional activities.
  • Ability 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 organizational 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-Biologicals Division is responsible for supervising the Quality Team in inspecting and testing procedures. Additionally, the role will be expected to frequently interact with co-workers, management, and the general public.

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