Quality Control Manager - Laboratory

Job Description Quality Control Manager - Laboratory The Quality Control Laboratory Manager report to the Associate Director, Quality Control Position Summary Come join a dynamic and rewarding Quality Control Group. The Quality Control Laboratory Manager is responsible for overseeing the commercial operation activities within the Quality Control department including raw material, in-process sample and finished product release to meet cGMP regulations and project timelines. Catalent's Winchester location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program. The Role Oversees daily aspects of QC laboratory including but not limited to testing and release of raw materials, in-process samples, finished products, cleaning verification samples, stability testing and protocol testing sample etc. Attain the strategic plans, establish goals and objectives, supervise work practices interprets and executes policies and procedures that typically affect organizational unit. Manages QC shift Supervisors, Principle Analysts, Senior Analysts and Analysts to follow cGMP regulations and meet the project timelines. Provides technical and compliance guidance to the QC laboratory with strong analytical techniques and troubleshooting skills in HPLC/GC/UV/IR/Dissolution etc. Manages and conducts Out of Specification, Out of Trend, Aberrant, deviation investigations including statistical analysis and risk assessment and supports audits in a timely manner. Manage QC laboratory CAPA implementations and the corresponding effectiveness checks to reduce the laboratory deviations. Responsible for the training (compliance and technical) and development of QC staff members.  Ensure all QC training records stay current. Provide effective leadership including staff recruiting, setting individual objectives, conducting employee performance reviews, recognizing employee contributions, coaching and developing staff. The Candidate Ph.D, or M.S.,or B.S., in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Chemistry). Work Experience -At least 1 years of pharmaceutical industry management experience, at least 5 years of chemistry laboratory experience withHPLC/GC/UV/IR/Dissolution etc. Must be able to interact with other departments within Catalent on daily basis and make extensive independent judgments Strong leadership skills, driving accountability, compliance and efficiency Solid knowledge of cGMP, ICH, FDA, EMA regulations or guidelines Be flexible on working hours and be able to be on call during off time since he/she manages four to five (4-5) QC shifts operations including weekend shifts. Position Benefits Works cross-functionally and receives exposure to several departments Medical, Dental, Vision and 401K are all offered from day one of employment 19 days of paid time off annually + 7 paid holidays Leadership Competencies for Performance and Development Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops About Catalent Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 
Salary Range: NA
Minimum Qualification
Not Specified years

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