KEY RESPONSIBILITIES
• Maintain the department procedures to ensure that process changes are documented
• Manage test schedules to ensure all operational tests are completed accurately and timely according to the department's policies and procedures
• Effectively communicate findings and remediation plans to both internal parties (senior management, business process owners, Compliance, Risk, Internal Audit, ) and external parties (e.g., clients, regulatory bodies, external auditors)
• Recommend and/or implement changes to existing operational test in order to increase efficiency, minimize operating expense or improve accuracy and timeliness of both process and system solutions
• Reviews production schedules and related information and confers with managers to plan and determine the quality control support required to support the flying hour program
• Conducts or directs training, and coordinates with unit managers and personnel as necessary to ensure implementation of policies and procedures
• Ensures sufficient manpower is available for planned work and shift coverage
• Conducts investigations into customer complaints relating to contractual deficiencies within the Quality Department
• Assesses inspection requirements and assign inspection projects and tasks to inspection personnel
ADDITIONAL ROLE INFORMATION:
Education and Professional Requirements:
• Bachelor's Degree, preferably in a related science or technical discipline, with 3+ years of experience in a regulated laboratory environment is required
• BS/MS in Microbiology, Chemistry, Food Technology or equivalent, with at least 3 year industry experience or similar in a GMP environment
Additional Skills / Competencies:
• Knowledgeable in HACCP, GMP's, MSDS now SDS CFR, and other state and federal regulatory requirements
• Leadership and supervisory skills.
• Excellent analytical and problem-solving abilities to address quality-related challenges.
• Good communication and interpersonal skills to collaborate with cross-functional teams and support quality initiatives.
• Detail-oriented with a focus on maintaining product quality and compliance