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The Supervisor Quality Control is responsible for leading the Quality Control team to ensure compliance with all Corporate and local policies, procedures, and regulations. The Supervisor Quality Control will also schedule laboratory testing and provide resource and instrumentation allocation, conducts laboratory investigations, and implements and monitors corrective actions. This role provides timely testing and notification of any aberrant occurrence to Management that presents potential negative impact to manufactured or marketed product. The Supervisor will monitor and maintain quality programs that provide assurance that test specifications are met for raw materials, components, finished products, intermediates, stability, and validation testing.
Job Responsibility:
Leading the Quality Control team to ensure compliance with all Corporate and local policies, procedures, and regulations
Scheduling laboratory testing and providing resource and instrumentation allocation
Conducting laboratory investigations
Implementing and monitoring corrective actions
Providing timely testing and notification of any aberrant occurrence to Management
Monitoring and maintaining quality programs that provide assurance for raw materials, components, finished products, intermediates, stability, and validation testing
Maintaining operational compliance with US and international regulatory agencies and guidelines (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Working cross functionally to coordinate testing schedules and communications
Performing testing as assigned
Scheduling and ensuring testing of production, raw materials, components, stability, validation, and support samples
Verifying, reviewing, and making appropriate changes to controlled documents
Ensuring team compliance with all policies, procedures, and site/company regulations
Supporting investigations of process or product failures and customer complaints
Authoring and/or reviewing all area quality and safety exceptions and investigation reports
Facilitating on time completion of corrective action items
Working safely with radioactivity and ensuring direct reports maintain radiological exposure to ALARA levels
Coaching and developing the team to High Performance
Setting clear vision and managing performance
Providing leadership through effective communication, coaching, training and development
Conducting daily Huddle board meetings
Measuring and communicating team progress against goals and KPIs
Managing department overtime
Maintaining an acceptable level of 5S in the area
Assuring compliance with department training and qualification
Requirements:
Bachelor Degree in Chemistry, Science or related field required. Work experience is considered in lieu of degree
10 or more years of relevant experience required with previous supervisory experience preferred
Proficiency in cGMP laboratory testing and major laboratory instrumentation
Ability to interpret laboratory data and make sound compliance decisions based on such interpretations
Excellent communication and interpersonal skills
Ability to coach, mentor and teach
Excellent decision making, problem solving and analytical skills
Change agent with the ability to influence at all levels of the organization
Detail-oriented with the ability to work under tight deadlines