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Summary of Position
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.
Essential Functions
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Work cross functionally to coordinate testing schedules and communications in support of the weekly production activities and ensure QC testing and maintenance activities are completed per requirements.
- Perform testing as assigned.
- Schedule and ensure testing of production, raw materials, components, stability, validation, and support of protocol/experimental samples.
- Verify, review, and make appropriate changes if needed, to any controlled document(s)pertinent to area of responsibility.
- Ensure team compliance with all policies, procedures, and site/company regulations.
- Support investigations of process or product failures and customer complaints. Author, and/or review all area quality and safety exceptions and investigation reports.
- Facilitate on time completion of all corrective action items assigned to area.
- Work safely with radioactivity and ensure all direct reports maintain radiological exposure to levels As Low As Reasonably Achievable (ALARA).
- Coach and develop the team to High Performance while fostering a culture of team ownership. Recognize and reward performance.
- Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
- Provide leadership for employees through effective communication, coaching, training and development and provide solutions for the success of the team.
- Conduct daily Huddle board meetings to update employees and track progress.
- Measure and communicate team progress against individual, team and site goals and Key Performance Indicators (KPI’s).
- Manage the department overtime (OT) and ensure that all exception reports are completed and submitted as required.
- Maintain an acceptable level of 5S in the area and promote proper maintenance and cleanliness of the department areas of responsibility.
- Assure 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.
- Ability to handle multiple priorities.
- Excellent conflict management skills.
- Builds positive relationships with others.
- Excellent time management skills.
