Job Information
Robert Half Manager of Quality Assurance - Manufacturing Product in Mayfield, Kentucky
Description
The individual who assumes this role will be responsible for supervising quality operations, ensuring safe and high-quality product output that is consistent in manufacturing due to specified methods and processes. This individual will serve as a strategic guide, technical specialist, and the leader for MCP's Quality Department. They will be tasked with supervising precise and swift analytical data compilation, adhering to Good Manufacturing Practices (cGMP), and ensuring the punctual and suitable release of Raw Material (RM) lots, Bulk Formula (BF) batches, and Finished Goods (FG) lots.
Position Title: Manager of Quality - Manufacturing Products
OVERALL PURPOSE/FUNCTION: We are seeking a dedicated Quality Manager with experience in quality assurance and control to ensure our products meet high-quality standards. This role involves managing our Quality Management System (QMS), inspecting products, providing guidance to team members, and liasing with project managers and customers to meet their expectations. This role also includes overseeing quality operations to ensure materials and methods produce a consistent, safe, high-quality product.
Responsibilities:
Monitor, manage, and encourage the growth of staff through collaborative growth plans.
Establish open communication for routine information sharing and open discussion with staff.
Develop processes for product quality inspection to meet company and customer standards.
Resolve issues through advanced problem-solving skills and implementation of corrective action plans.
Manage project completion within timeframe and budget.
Support operational functions while ensuring compliance with regulatory protocols.
Review testing data and authorize release of product lots.
Write, review, and/or approve documents including SOPs and Work Instructions.
Oversee the execution of validation protocols.
Act as Lead or Associate Investigator for deviation and OOS investigations.
Assist as a primary resource during outside audits and regulatory inspections.
Perform and assist with internal audits of company departments and systems.
Requirements:
At least five years of experience in a quality or life science role within a manufacturing environment.
Knowledge and experience with FDA\EPA regulatory standards.
Competency in computer skills, including MS Office.
ASQ, CQE, Six Sigma Belt or Certified Quality Auditor Certifications are a plus.
History of successful and strong leadership, detail-orientation, adaptability, resilience, creativity, and emotional intelligence.
Analytical, Mathematical, and a great communicator (verbal and written).
This position offers an excellent opportunity to apply your quality assurance and management skills in a dynamic and rewarding environment. This role is pivotal in maintaining high-quality standards in products and services, offering the chance to contribute to the success and growth of the company.
Requirements Atlassian Jira, Bug Tracking, Database, EO/IR systems, HP Quality Center, AB Testing, Automation, Defect Management, Design, Integration, ASQ Certified Quality, Raw Materials, Raw Material Inventory, Finished Goods, Formulary, FDA GMP, FDA 21 CFR, GxP FDA, Cost Savings, Continuous Process Improvement, Drive Continuous Improvement, Business process improvement, Operational improvement, Performance Improvement Plans, Customer satisfaction improvement, Process Improvement, Process Improvement Initiatives, Process Improvement Projects, Quality Improvement, Recommend Improvements, GMP, Current Good Manufacting Practice Regulations (CGMP), CGLP, Process Documentation, Support documentation, User Documentation, Department SOP's, Work Instructions, CAPA, Budget allocations, Budget monitoring, Budgeting, Regulatory Agencies, Regulatory Audits, Regulatory Compliance, Regulatory Documents, Regulatory Examinations, Regulatory Inspections, Regulatory Policies, Regulatory Standards, Quality Engineering, Supplier Quality Engineering, Six Sigma, Quality Audits Technology Doesn't Change the World, People Do.®
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