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QC Scientist II - Microbiology Method Qualifications-8889131004
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QC Scientist II – Microbiology Method Qualification, 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 II will provide testing, technical and troubleshooting support in the QC
Microbiology Laboratory. These functions include: Collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs).
This position will have thorough knowledge of SOPs, USP and other applicable pharmacopeia. Possess foresight to recognize task needs and performs the trained task without the request of management. They will review and/or write the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data. They will also perform statistical analysis in support of APRs, Stability, and Product Release. This position complies with cGMPs, safety training and regulations. Performs more advance technical projects under the supervision of management. Maintain an environment of respect and teamwork with all coworkers.
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. Minimum 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required. Experience performing routine laboratory activities is required. Basic knowledge/exposure of LIMS and/or an electronic data laboratory system is preferred. Demonstrate experience writing SOPs and protocols for method qualification 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. The ideal candidate will preferably possess previous lab start-up experience and be able to perform statistical analysis in support of APR, stability and product release. The ability to work independently, manage timeline and decision making is required.
This candidate will be based in Fort Washington, 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.
J2W:LI
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: Quality Control
Relocation: Eligible No
Travel:Yes, 10 % of the Time
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 II - Microbiology Method Qualifications-8889131004
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QC Scientist II – Microbiology Method Qualification, 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 II will provide testing, technical and troubleshooting support in the QC
Microbiology Laboratory. These functions include: Collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs).
This position will have thorough knowledge of SOPs, USP and other applicable pharmacopeia. Possess foresight to recognize task needs and performs the trained task without the request of management. They will review and/or write the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data. They will also perform statistical analysis in support of APRs, Stability, and Product Release. This position complies with cGMPs, safety training and regulations. Performs more advance technical projects under the supervision of management. Maintain an environment of respect and teamwork with all coworkers.
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. Minimum 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required. Experience performing routine laboratory activities is required. Basic knowledge/exposure of LIMS and/or an electronic data laboratory system is preferred. Demonstrate experience writing SOPs and protocols for method qualification 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. The ideal candidate will preferably possess previous lab start-up experience and be able to perform statistical analysis in support of APR, stability and product release. The ability to work independently, manage timeline and decision making is required.
This candidate will be based in Fort Washington, 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.
J2W:LI
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: Quality Control
Relocation: Eligible No
Travel:Yes, 10 % of the Time
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.