Cold Chain Manager - Quality Assurance

Posted 2 days ago

revere transportationNorton (OH)

SENIORITY

Mid

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About the role

TITLE: Cold Chain Manager - Quality AssuranceREPORTS TO: VP, High Value ServicesJOB PURPOSE: Establish, implement and manage the company's Cold-Chain Quality Program. Provide knowledge, experience and training to drive Cold-Chain excellence throughout the organization. Develop and implement industry best practices to achieve and maintain cGMP standards compliance.
PRIMARY RESPONSIBILITIES: Ensures Cold-Chain quality assurance system is in place that meets all required regulations. Develop processes and manages all documentation for Cold-Chain quality assurance program, including but not limited to: standard operating procedures, training documentation, corrective actions, change control, equipment qualification and software validations. Establish and maintain standards for trailers, calibration, validation and mapping protocols. Provides oversight for all equipment mapping, validation and equipment calibration. Define roles and responsibilities for all employees involved in Cold-Chain process. Responsible for compliance and to drive the execution of all Cold-Chain quality assurance processes to ensure an efficient and effective Cold-Chain operation. Hosts and facilitates all audits performed by clients. Ensures all internal audits are performed per schedule and all findings are communicated with department managers and senior management. Audit and qualify any vendors that are utilized for Cold-Chain services. Responsible for coordinating the investigation of any Cold-Chain quality complaint and report the results and the corrective action. Manages the department resources to execute the Cold-Chain quality assurance program and support the daily operations.
EDUCATION: Minimum High School Diploma Bachelor's degree preferred Knowledge of cGMP, PDA, 21 CFR and understanding of Quality Systems Knowledge of ISO 9001 requirementsKEY SKILLS and COMPETENCIES:Strong communication, organizational and customer service skills. Strong attention to detail, follow through and the ability to communicate and control activities through third party providers. Ability to write, and maintain Cold-Chain SOPsEffective analytical and project management skills. To apply, please email recruiting@reveretransport.com.

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