Biological Quality Assurance Manager

2 weeks ago

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

POSITION SUMMARY:

The Biological Quality Assurance Manager is tasked with guaranteeing adherence to environmental and quality regulations by conducting thorough research, analyzing relevant data, leading the quality assurance initiatives, providing expert technical assistance, overseeing the Quality team, and fostering ongoing enhancements within the organization's quality frameworks and standards.

KEY RESPONSIBILITIES:

  • Strategically plan, coordinate, and manage the quality assurance initiatives for the Biologicals division to ensure compliance with established benchmarks.
  • Champion and implement quality frameworks, standards, inspection protocols, and testing methodologies.
  • Develop, execute, and evaluate quality reporting metrics while addressing quality system challenges.
  • Offer technical guidance and support for product manufacturing, including documentation, process flow diagrams, and specifications for raw materials.
  • Ensure compliance with relevant regulations, including FDA and ISO standards.
  • Analyze data to identify root causes of issues and implement corrective actions.
  • Effectively manage multiple tasks with strong time management skills.
  • Promote the Quality System-Biologicals as part of the organization's commitment to continuous improvement and adherence to established 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 leadership 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, including 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 and deliver 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 quality standards (e.g., ISO 9001) is essential.

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Comprehensive understanding of scientific methodologies and laboratory processes, including testing and quality assurance protocols.
  • In-depth 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 protocols, and testing methodologies.
  • Proven ability to lead, supervise, and develop a team, including providing training and fostering a collaborative work environment.
  • Skilled in identifying problems, 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 level of ethics and integrity in all professional activities.
  • Ability to make rational, objective, and fact-driven 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 for the Biologicals Division is responsible for supervising the Quality Team in inspecting and testing procedures. This role will also require frequent interaction with co-workers, management, and external stakeholders.

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