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QC Scientist III - Microbiology- Investigations-8935131003
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QC Scientist III – Microbiology – Investigations – 2nd Shift, 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 QC Scientist III – Microbiology – Investigation will provide final review of all test samples (components, raw materials, in-process bulk, finished product, commercial stability, method transfer, method development and qualification, and cleaning validation) in the QC Microbiology Laboratory, 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.
The QC Scientist III – Microbiology – Investigation requires thorough knowledge of domestic and international requirements, the ability to interact with other departments, and excellent written and oral communication skills. This position authors, reviews and leads lab investigations. Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data, and laboratory investigations. This position also possess foresight to recognize task needs and performs the trained task without the request of management. Provide technical support and trouble-shooting for technical issues internally and externally. They will perform statistical analysis in support of APRs, Stability, and Product Release. They will also comply with cGMPs, safety training and regulations. This position maintains an environment of respect and teamwork with all coworkers, acts as technical advisor for testing issues and interacts with regulatory agencies as required. Substitutes for the supervisor in his/her absence.
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 in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required. A minimum 4 years of GMP/GLP quality control lab experience. A minimum of 6 years in a pharmaceutical and/or OTC and/or regulated environment is required. Capable of performing routine laboratory activities is required. Basic knowledge/exposure of a LIMS and/or an electronic data laboratory system is preferred. Demonstrated experience writing SOPs and protocols with a thorough knowledge of USP and other compendial methods is required. Experience conducting bioburden and microbial limit testing is required. Microbial effectiveness testing, environmental monitoring and cleaning validation experience are preferred. Previous QC microbiology lab experience is required. Previous lab investigations experience is required. Previous experience in OOS, OOT, non-conformance, CAPA is preferred. Previous experience writing investigations is required.
This candidate will be based in Fort Washington, PA and will be required to travel less than 10% domestically. This is a second shift position.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: Quality Control
Relocation: Eligible No
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.
QC Scientist III - Microbiology- Investigations-8935131003
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QC Scientist III – Microbiology – Investigations – 2nd Shift, 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 QC Scientist III – Microbiology – Investigation will provide final review of all test samples (components, raw materials, in-process bulk, finished product, commercial stability, method transfer, method development and qualification, and cleaning validation) in the QC Microbiology Laboratory, 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.
The QC Scientist III – Microbiology – Investigation requires thorough knowledge of domestic and international requirements, the ability to interact with other departments, and excellent written and oral communication skills. This position authors, reviews and leads lab investigations. Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data, and laboratory investigations. This position also possess foresight to recognize task needs and performs the trained task without the request of management. Provide technical support and trouble-shooting for technical issues internally and externally. They will perform statistical analysis in support of APRs, Stability, and Product Release. They will also comply with cGMPs, safety training and regulations. This position maintains an environment of respect and teamwork with all coworkers, acts as technical advisor for testing issues and interacts with regulatory agencies as required. Substitutes for the supervisor in his/her absence.
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 in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required. A minimum 4 years of GMP/GLP quality control lab experience. A minimum of 6 years in a pharmaceutical and/or OTC and/or regulated environment is required. Capable of performing routine laboratory activities is required. Basic knowledge/exposure of a LIMS and/or an electronic data laboratory system is preferred. Demonstrated experience writing SOPs and protocols with a thorough knowledge of USP and other compendial methods is required. Experience conducting bioburden and microbial limit testing is required. Microbial effectiveness testing, environmental monitoring and cleaning validation experience are preferred. Previous QC microbiology lab experience is required. Previous lab investigations experience is required. Previous experience in OOS, OOT, non-conformance, CAPA is preferred. Previous experience writing investigations is required.
This candidate will be based in Fort Washington, PA and will be required to travel less than 10% domestically. This is a second shift position.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: Quality Control
Relocation: Eligible No
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.