Quality Manager External Microbiology Laboratories-9410140714
Description
McNeil Healthcare PPC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Manager External Microbiology Laboratories, 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 Quality Manager External Microbiology Laboratories, QACO will support the contracted testing and/or storage of OTC Drugs and Medical Devices, including but not limited to release testing of raw materials, components, active pharmaceutical ingredients, finished products, stability testing, complaint sample assessment with focus on microbiology testing requirements. The QM-EML will represent QACO in the selection, management & control of Contract Laboratories. The QM-EML will be key to the identification, qualification & ongoing management of CLs used by McNeil sites through collaboration with procurement & sending sites. The QM-EML will participate in and/or evaluate cGMP audits and develop and negotiate Quality Agreements.
The Quality Manager External Microbiology Laboratories will provide MCH site support by identifying suitable laboratory(ies) for required testing, participating in change control activities to qualify the laboratory(ies), including review and approval of protocols & reports. The QM-EML will assist in the resolution of nonconformance events as needed, data review, and the review of regulatory submissions associated with testing activities or changes, as applicable. The QM-EML will further maintain the qualified material/product lists for each laboratory, maintaining up to date approved testing tables for each contract lab location. The QM-EML will drive compliance & quality improvement initiatives through reporting and assessment of cumulative performance metrics and conduct of management reviews.
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 a Bachelors degree in Microbiology, Life Science or a related discipline is required. An advanced degree is preferred. A minimum of 8 years Quality Assurance principles and practices experience in the pharmaceutical, biological and/or OTC Drug product area in an FDA-regulated industry is required. A minimum of 4 yrs within Microbiology Laboratory is required.
Expert Knowledge of cGMP requirements and current FDA enforcement issues, expert knowledge of microbiological testing requirements & laboratory instrumentation, method validation, and compendia requirements is required. Experience working on cross-functional Project teams is required. Understanding of product development and product stability is preferred.
Demonstrated ability to manage Quality issues and drive resolution is required. Work independently on complex issues; serving as a subject matter / technical expert within the laboratory functional area required. Excellent analytical, prioritization, communication, and strong leadership skills and the ability to communicate with and influence all levels of the organization is required. Experience negotiating requirements and developing win-win solutions across diverse functions required. Previous management experience is strongly preferred. Process Excellence/Six Sigma Certification, ASQ Certified Quality Engineer / Auditor preferred.
This position will be located in Fort Washington, PA. This candidate must be able to perform physical inspections and/or visits of laboratory facilities as part of facility audits and must be available to travel up to 20%.
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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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