HireDiversity

Lancaster, PA, US

Microbiology Lab Manager - Lancaster, PA-0000033A

Description

McNeil Consumer Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Microbiology Lab Manager located in Lancaster, 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, PediaCare® upper respiratory medicines for infants and children, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants.

McNEIL-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J family of companies or beyond, or whether this is your entry to the J&J family of companies, we invite you to join us….

Creating the future of McNeil.

The Microbiology Lab Manager manages the Quality Control Microbiology Laboratory staff at JJMCP-Lancaster. These functions include the testing of: chemical components, bulk and finished products, packaging materials, scale-up samples, process validation samples, cleaning validation samples, marketed stability samples, development samples, and Investigational samples. This individual will review and approve: SOPs, testing protocols, laboratory investigations, laboratory equivalency protocols and method qualification protocols. This individual will provide and/or manage cGMP and safety training to the QC-Microbiology Staff. The Microbiology Lab Manager will provide information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries. This individual will develop and implement procedural guidelines within the Quality Control Unit in conjunction with J&J and McNeil Central Quality Assurance. This individual represents the department internally and externally in matters relating to the Microbiology QC Laboratory, cGMPs and general quality. In addition, the Microbiology Lab Manager is responsible for hiring, firing, disciplining and rewarding of employees.

Qualifications


A Bachelors degree is required. A degree in Microbiology or related discipline is required. A minimum of 7 years of professional experience is required. A minimum of 5 years of experience in a regulated QA environment is required. A minimum of 3 years of supervisory experience is required. Broad-based experience, or combination of experience, in pharmaceutical manufacturing or OTC is preferred. Significant knowledge of FDA Regulations, specifically 21 CFR 210 and 211 as they apply to a microbiology lab environment is required. Experience with current Good Manufacturing Practices is required. Experience with Good Laboratory Practices regulations is preferred. Thorough understanding of QA/QC systems and manufacturing processes is required.

Strong written and verbal communication skills are required. This candidate will have solid influencing skills to drive process and technical improvements and must have the ability to drive innovation within their functional area.

This position will require up to 10% travel and is based in Lancaster, PA.

Assignment duration of the Microbiology Lab Manager to last approximately three years.

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.

Be Vital in your career, Be Seen for the talent you bring to your work. Explore opportunities in the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Relocation: Eligible
No
Job Function: Quality Control