Johnson & Johnson Careers

Microbiology Laboratory Manager

Las Piedras, Puerto Rico
Biology


Job Description

Requisition ID: 0558180123

McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Microbiology Laboratory Manager. 

McNeil Consumer Healthcare markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products; BENADRYL®, ZYRTEC® and ZYRTEC®-D allergy medicines; IMODIUM® A-D anti-diarrheal; MOTRIN® IB; and SUDAFED® and SUDAFED PE® nasal decongestants.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

As the Microbiology Laboratory Manager, you will: 
• Manage the Microbiology Laboratory of the McNeil Las Piedras facility.  This includes microbiological testing of bulk or finished product, raw materials, packaging components, water, compressed air, cleaning validation or monitoring samples, stability samples, technology transfer samples and when required, investigational samples. 
• Control and assure that the Microbiology Laboratory conforms to the appropriate standards of quality and purity, including compliance with current Good Manufacturing Practices (cGMPS), current Good Laboratory Practices (cGLPs) and safety requirements.  You will manage procedures, systems and practices to ensure compliance with all regulatory requirements.
• Ensure that timely reports related to the laboratory activities are prepared, submitted and approved. Approve procedures and relevant quality documentation.  Serve as Subject Matter Expert and responsible for review and sign-off of relevant documentation.
• Interact with Regulatory Health Authorities in representation of the Microbiology Laboratory function during inspections. When required, provide input for responses to audit observations.
• Represent the Microbiology Laboratory in diverse company forums, and in the absence of Senior Laboratory Manager, represent Quality Control management. Act in accordance to the principles expressed in Our Credo in all activities within and outside the company. 
• Jointly with the Laboratory Integrator, manage the schedule and planning of the laboratory for maximum effective utilization of resources, to budgetary and quality standards and target cycle times.
• Serve as liaison to United States Over-The-Counter Senior Plant Hygienist for evaluation and proposal of methods to improve laboratory processes and procedures or for discussion of complex investigations.
• Provide support to laboratory equipment qualification, calibration and preventive maintenance programs.
• Notify management of atypical trends, discrepancy or non-compliance issues. As well as, ensure adequate resources to support investigations, oversee investigations for timely notification to management of results and resolution of issues, provide input for risk assessments, and when delegated, approve investigations as Functional Area Manager. 
• Drives improvements towards efficiency and simplified processes balanced with compliance.  Ensures team actively participates and applies learning of process excellence program.  Acts as champion for process excellence program applied to Microbiology Laboratory.

Qualifications
• A minimum of a bachelor’s degree is required, preferably in Natural Science with a degree focus in Microbiology.
• At least eight (8) years of experience in the manufacturing regulated environment (Pharmaceutical, Medical Device or Consumer) is required. 
• Microbiology laboratory experience and in-depth knowledge is required. 
• A minimum of four (4) years of supervisory experience is required.  
• Knowledge of current Good Laboratory Practices (cGLP) and current Good Manufacturing Practices (cGMPs) is required.
• Knowledge of water systems, preferably purified water systems, is highly desirable.
• Proven leadership, initiative and interpersonal skills are required, as well as the ability to administer team building strategies. 
• Computer literate in the use of Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required. Experience with LIMS or SAP is preferred. 
• Proficiency in English and Spanish (oral and written) is required. 
• This position is located in Las Piedras, PR and requires up to ten percent (10%) of travel. Ability to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business is required.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-Puerto Rico-Las Piedras
Organization
McNeil Healthcare LLC (7598)
Job Function
Biology
Requisition ID
0558180123