Johnson & Johnson companies are equal opportunity employers.
QC Microbiology Laboratory Manager-0258140128
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Microbiology Laboratory 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 and SUDAFED® nasal decongestants.
The QC Microbiology Lab Manager manages the QC Microbiology testing laboratory for the McNeil Lancaster facility. These functions include the microbiological 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. Review and approval of: SOPs, testing protocols and method qualifications protocols. Provide and/or manages cGMP and safety training to the QC Micro staff. Provide information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries. Develop and implement procedural guidelines within the Quality Control Microbiology laboratory in conjunction with Central Quality Assurance and other plant sites. Represents the department internally and externally in matters relating to the Microbiology Laboratory, cGMPs and general quality. Responsible for hiring, firing, disciplining and rewarding of employees.
The QC Microbiology Lab Manager controls and assures that the Microbiology Laboratories conform to the appropriate standards of quality and purity for chemical components, bulk and finished products, packaging materials, scale-up samples, process validation samples, cleaning validation samples and marketed stability samples. Administers training and development of Team Leaders and Senior Microbiologists. Facilitates team building and meetings with the entire Micro Lab. Manages the laboratory equipment qualification, calibration and Preventive Maintenance programs. Audits the laboratory for compliance to cGMPs and safety requirements. Manages and develops procedures, systems and practices to ensure compliance to all regulatory requirements. Manages all laboratory projects from internal and external departments, suppliers and subcontractors. Develops and implements systems and training to ensure successful completion of these projects. Manages the planning and scheduling of the laboratory areas for maximum effective utilization of employees, equipment and material within budgetary and quality standards. Appraises the Director, Site Quality in employee promotions, merit increases, transfers, leaves of absence and other personnel changes required. Represents the Micro laboratories during FDA, DEA, other regulatory agencies and Corporate audits. Develops and implements policies and procedures specific to the Microbiological laboratory. Participates in the development and implementation of national laboratory policies and procedures. Forecast the need for new equipment and personnel to serve expanding operational and regulatory requirements sufficiently in advance of the need. Requisitions and selects qualified employees necessary to perform work. Administers the objectives and goals of the department. Performs other duties as required.
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 Bachelors of Science degree in Microbiology, Biology, Chemistry, Natural Sciences or equivalent combination of education and experience is required. A minimum of 8 years of QC/R&D Microbiology Laboratory experience in a pharmaceutical/OTC industry environment is required. A minimum of 3 years of supervisory experience is required. Experience in the application of cGMPs in the pharmaceutical industry is required. Basic knowledge of Pharmaceutical Manufacturing & cGMPs is required. Basic knowledge of Microbiological techniques and applications is required. Basic knowledge of Statistics and Quality Engineering principles is preferred. Ability to administer team building strategies is required. Demonstrates good interpersonal skills is required.
This candidate will be based in Lancaster, PA and will be required to travel less than 10% domestically.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Control
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
QC Microbiology Laboratory Manager-0258140128
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Microbiology Laboratory 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 and SUDAFED® nasal decongestants.
The QC Microbiology Lab Manager manages the QC Microbiology testing laboratory for the McNeil Lancaster facility. These functions include the microbiological 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. Review and approval of: SOPs, testing protocols and method qualifications protocols. Provide and/or manages cGMP and safety training to the QC Micro staff. Provide information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries. Develop and implement procedural guidelines within the Quality Control Microbiology laboratory in conjunction with Central Quality Assurance and other plant sites. Represents the department internally and externally in matters relating to the Microbiology Laboratory, cGMPs and general quality. Responsible for hiring, firing, disciplining and rewarding of employees.
The QC Microbiology Lab Manager controls and assures that the Microbiology Laboratories conform to the appropriate standards of quality and purity for chemical components, bulk and finished products, packaging materials, scale-up samples, process validation samples, cleaning validation samples and marketed stability samples. Administers training and development of Team Leaders and Senior Microbiologists. Facilitates team building and meetings with the entire Micro Lab. Manages the laboratory equipment qualification, calibration and Preventive Maintenance programs. Audits the laboratory for compliance to cGMPs and safety requirements. Manages and develops procedures, systems and practices to ensure compliance to all regulatory requirements. Manages all laboratory projects from internal and external departments, suppliers and subcontractors. Develops and implements systems and training to ensure successful completion of these projects. Manages the planning and scheduling of the laboratory areas for maximum effective utilization of employees, equipment and material within budgetary and quality standards. Appraises the Director, Site Quality in employee promotions, merit increases, transfers, leaves of absence and other personnel changes required. Represents the Micro laboratories during FDA, DEA, other regulatory agencies and Corporate audits. Develops and implements policies and procedures specific to the Microbiological laboratory. Participates in the development and implementation of national laboratory policies and procedures. Forecast the need for new equipment and personnel to serve expanding operational and regulatory requirements sufficiently in advance of the need. Requisitions and selects qualified employees necessary to perform work. Administers the objectives and goals of the department. Performs other duties as required.
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 Bachelors of Science degree in Microbiology, Biology, Chemistry, Natural Sciences or equivalent combination of education and experience is required. A minimum of 8 years of QC/R&D Microbiology Laboratory experience in a pharmaceutical/OTC industry environment is required. A minimum of 3 years of supervisory experience is required. Experience in the application of cGMPs in the pharmaceutical industry is required. Basic knowledge of Pharmaceutical Manufacturing & cGMPs is required. Basic knowledge of Microbiological techniques and applications is required. Basic knowledge of Statistics and Quality Engineering principles is preferred. Ability to administer team building strategies is required. Demonstrates good interpersonal skills is required.
This candidate will be based in Lancaster, PA and will be required to travel less than 10% domestically.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Control
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement