Manager Quality Control

* ** Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines.**
* ** Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications.**
* ** Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements.**
* ** Maintain accurate records of all QC activities, including test results, deviations, and corrective actions.**
* ** Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality.**
* ** Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).**
* ** Prepare for and participate in internal and external audits, including regulatory inspections.**
* ** Oversee calibration, validation, and maintenance of laboratory instruments.**
* ** Provides subject matter assistance for LIMS, methods, testing, and validation.**
* ** Manages QC testing group to achieve compliant testing in a timely manner.**
* ** Manages Lab investigations and OOSs including remediation of potential compliance concerns.**
* ** Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement.**
* ** Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation.**
* ** Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions.**
* ** Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations.**
* ** Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades.**
* ** Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory.**
* ** Ensures key turnaround timelines for customer service and compliance requirements are achieved.**
* ** Performs as a subject matter expert during customer and regulatory audits.**
* ** Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle.**
* ** DEPARTMENT SPECIFIC/NON
- ESSENTIAL FUNCTIONS:

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* ** Develops and coaches to build talent.**
* ** Participate in a 5S Workplace System to ensure good housekeeping and organization.**
* ** Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.**
* ** Effectively trains others in a positive manner.**
* ** Other duties as assigned with or without accommodation.**
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* MINIMUM REQUIREMENTS:

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* Education:

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* ** B.S. /B.A. in Physical Science required.*
* ** Master’s Degree preferred.*
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* Experience:

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* ** 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements*
* ** Preferred Skills/

Qualifications:

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* ** Other Skills/

Competencies:

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* ** Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories*
* ** Experience with testing API or Pharma products*
* ** Experience leading a group of up to 20 people with 24/7 shift operations*
* ** Excellent written and verbal communication and leadership skills*
* ** Ability to work in and promote a team environment*
* ** Working knowledge of Six Sigma and/or Lean manufacturing tools*
* ** Sense of urgency.*
* ** Action oriented/drives for results*
* ** Excellent communication and interpersonal skills*
* ** Team orientation/strong team player*
* ** Ability to coach, mentor and teach*
* ** Excellent decision making, problem solving and analytical skills*
* ** Strong managerial courage*
* ** Ability to influence change at all levels of the organization*
* ** Detail-oriented with the ability to work under tight deadlines*
* ** Excellent…