Supervisor Analytical Laboratory-5131140227
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Supervisor Analytical Laboratory, located in Fort Washington, Pennsylvania.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The Supervisor Analytical Lab supervises the activities of all laboratory personnel and substitutes for the Manager in his/her absence. Performs final review of all test samples (components, raw materials, method transfer, method development and qualification, and cleaning validation) so as to provide a high degree of assurance that all data is handled, managed, and released in a technically competent, compliant and efficient manner. This position requires thorough knowledge of domestic and international requirements, the ability to interact with other departments, and excellent written and oral communication skills. This position interacts with various internal departments and external divisions on a routine basis to coordinate manufacturing, release, stability, development, and validation efforts. Provides technical support and trouble-shooting for technical issues internally and externally. Authors, reviews and leads lab investigations. Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and analysis of data, and laboratory investigations. Ensures compliance with cGMP's and safety training and regulations. Maintains an environment of respect and teamwork with all coworkers. Acts as technical advisor for testing issues. Interacts with regulatory agencies as required
The Supervisor Analytical Labcollects and provides required APR/PQR quality attribute data and an analysis of the data per established templates and work instructions. Utilize tools within MS office and other systems to improve business effectiveness. Exposure to & working knowledge of electronic batch records and/or other automated processes/systems (labs). Working knowledge of SAP or ERP system; including other relevant systems per role. Working knowledge of an automated system. Be the Analytical Lab SME to understand the critical aspect of product, component and labeling requirements. Point of reference for Audit and acts as SME. Understanding of product family, product size and put-up, and product characteristics (color, viscosity) associated active and excipient. Critical parameter associated with all processing steps.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of Bachelor’s degree is required. A focus degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology or related science is preferred. Minimum 4 years of GMP quality lab experience is required. Experience in finished product testing, cleaning development/validation testing & stability program experience is required. Experience in troubleshooting laboratory equipment is preferred. Prior supervisory experience is preferred. Basic knowledge/exposure of a LIMS system, SAP and Chromatographic system software is preferred.
This candidate will be based in Fort Washington, PA and will be required to travel less than 10% domestically. For the year 2014 this position will be 1st shift and starting in 2015 this position will be 2nd shift.
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Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Control
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