Pel-Freez, LLC

About Us

<div>JOB SUMMARY:The Biologicals Quality System Manager is responsible for ensuring environmental and quality compliance by conducting research, analyzing data, directing the quality assurance program, providing technical support, managing the Quality team, and promoting continual improvement within the company's quality systems and standards.ESSENTIAL DUTIES, FUNCTIONS, AND RESPONSIBILITIES:<ul><li>Plan, coordinate, and direct the quality assurance program (Biologicals division) to ensure products meet established standards.</li><li>Promote and execute quality systems, standards, inspection processes, and test methodologies.</li><li>Develop, execute, and analyze quality reporting measures and manage quality system issues.</li><li>Provide technical support and guidance for product production, including documentation, process flow charts, and raw material specifications.</li><li>Ensure compliance with applicable regulations, including FDA and ISO standards.</li><li>Analyze data to determine the root causes of problems and implement solutions.</li><li>Handle multiple tasks efficiently with effective time management skills.</li><li>Understand and promote the Quality System-Biologicals as part of the company's commitment to continual improvement and adherence to policies and procedures.</li><li>Act as the primary Management Representative for ISO and the company Quality System.</li><li>Participate in design development projects to represent Quality Systems.</li><li>Design, document, and implement methods for process control, improvement, testing, and inspection.</li><li>Report on quality system issues, trends, and losses to management.</li><li>Provide direction and support for internal Quality System development and maintenance.</li><li>Interface with the quality team on quality system problems.</li><li>Hire, train, and manage the Quality team, including handling promotions, demotions, transfers, and terminations.</li><li>Address product deficiencies, track corrective actions, and ensure timely and accurate customer communication.</li><li>Assist or lead internal and external audits and provide quality assurance training.</li><li>Determine product disposition and evaluate retained, returned, and released products.</li><li>Review and ensure accuracy of final release documents and customer complaints.</li><li>Verify product quality through daily control sheets and Quality shipping logs.</li><li>Guide laboratory personnel on quality and product/processes and support technical development activities.</li><li>Manage and control quality documents and maintain accurate inventory related to product release.</li><li>Perform any other related duties as assigned.</li><li>Exhibit exemplary attendance and punctuality.</li></ul> Based on the essential duties listed above, this position is considered safety-sensitive and therefore all work must be performed following quality standards and established safety procedures.EDUCATION & RELATED EXPERIENCE:<ul><li>A bachelor's degree or higher in science or a related field is required.</li><li>Experience with quality principles and the interpretation and application of quality standards of industry regulations (e.g., ISO 9001) is required.</li></ul>KNOWLEDGE, SKILLS, AND ABILITIES:<ul><li>Comprehensive understanding of scientific methods and lab processes, including testing and quality assurance procedures.</li><li>In-depth knowledge of industry standards, ISO programs, USDA regulations, and the company's biological products and processes.</li><li>Excellent communication and interpersonal skills, capable of effectively interacting with all levels of the organization and external stakeholders.</li><li>Strong technical skills in quality systems, inspection processes, and test methodologies.</li><li>Proven ability to lead, supervise, and develop a team, including providing training and fostering a collaborative work environment.</li><li>Skilled in identifying problems, analyzing root causes, and implementing effective solutions to improve processes and enhance efficiency.</li><li>Ability to drive continuous improvement initiatives and modernize existing quality systems, ensuring the company remains responsive to market needs.</li><li>Demonstrated a high level of ethics and integrity in all professional activities.</li><li>Ability to make rational, objective, and fact-driven decisions.</li><li>Meticulous attention to detail, ensuring accuracy and quality in all aspects of work.</li><li>Strong business acumen and understanding of the importance of quality management in supporting company profitability and customer satisfaction.</li><li>Ability to adapt to changing conditions and be flexible in optimizing and adjusting processes to meet evolving needs and customer feedback.</li></ul>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. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. <a rel="nofollow" href="https://pelfreez.isolvedhire.com/jobs/1317215-457037.html">https://pelfreez.isolvedhire.com/jobs/1317215-457037.html</a></div>