Job Description
Quality Assurance QA Manager
Detroit, MI
Duration: Full Time
Job Description
Purpose:
Responsible for the direction and coordination of quality operations in support of meeting or exceeding cGMP and FDA requirements. Insures accordance with quality, safety standards and all regulatory requirements. Insures compliance of departmental procedures to cGMP’S, and provides training, of employees. Insures timely implementation of testing and in-process monitoring systems to ensure process control and product quality. Typically has one or more supervisors with direct reporting relationship. Typical span of control = 25+ employees.
Essential Duties:
Oversees and insures area operations are consistent with company policies and manages the application and administration of such polices in conformance with cGMP’S.
Directs and co-ordinates the activities of subordinate supervisors, and employees through the development of valid performance plans to ensure timely testing and measurement of products consistent with objectives. Establishes short-term performance goals, training plans, and competency development and insures results in a changing environment.
Establishes, maintains, and continually analyzes qa/qc operational procedures to assure departmental compliance with Good Manufacturing practices, improve yields, or reduce cost.
Ensure that all products are tested according to Quality standards and specifications through daily review and approval of appropriate records and oversees routine audits of quality systems.
Develop, train and motivate subordinate personnel to maximize job performance through skills development, and employee education.
Monitor and maintain employee absentee, tardiness and work rule policies. Recognize the roles and functions of peers and maximize the benefits of departmental inter-relationships to meet plant objectives. Provide an environment, which fosters involvement in total customer satisfaction by all department members, which results in an effective team effort achieving personal and company objectives.
Establish and maintain safe quality assurance/quality control environments and processes in compliance with regulatory and corporate policies. Conduct and participate in safety programs with subordinates. Establish and maintain adequate preparatory and sanitation programs to meet employee and product safety requirements and good manufacturing practices. Maintain an effective audit program to assure safe and sanitary conditions.
Required Skills
Job Qualifications:
Core Competencies
Ability ability to motivate others through forward looking practices in the quality field. Knowledge of employee practices and principles, knowledge of state and federal employment laws relating to key areas of responsibility, Analysis and Reporting, Communication and Presentation, Relationship Building, Information and Technology Proficiency, Function, Department and Company Representation, Problem Solving and Decision Making, basic MS Office, intermediate MS Excel, basic Lotus Notes.
Work Experience
Overall management of professional staff of 50+ and coordination of technical quality function; insure compliance with budget, quality, safety standards and all regulatory requirements; oversee QA & QC policies; manage application and administration of QA & QC policies in conformity with cGMPs; direct and coordinate activities of subordinate managers, supervisors, trainers and employees through development of valid performance plans to ensure m
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