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QC Scientist II-8717140114
Description
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. is currently recruiting a QC Scientist II, to be located in Fort Washington, PA.
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 provides testing, technical and troubleshooting support in the QC laboratories. 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). 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. Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data. Performs statistical analysis in support of APRs, Stability, and Product Release. Complies with cGMPs, safety training and regulations. Performs more advance technical projects under the supervision of management. Maintains an environment of respect and teamwork with all coworkers.
The QC Scientist II will perform under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines. The will provide support during regulatory inspections /audits as directed. Support may be in the form of scribes, runner, and document gathering. He/she will attend GMP training on the schedule designated for the role and as appropriate for the role. The QC Scientist may provide statistical analysis in support of the APR and Stability processes. The individual will embrace a behavior of employee involvement and commitment to doing the job right the first time. He/she will have a strong working GMP knowledge. Communicates and identifies GMP gaps and can participate in all types of audits & Inspections. The QC Scientist II leads areas in ensuring all operations (processes) are completed in a compliant and safe manner and assists in coordination efforts in case of emergency- spill, fire etc. The individual will take necessary action to eliminate and immediately address safety hazards. Communicate any observed unsafe behaviors immediately. He/she will understand the safety concerns and promotes a safety conscience culture for their job function and wear the appropriate PPE when working in manufacturing and other hazardous working environments and advocates standards of safety. The individual will contribute to and attend all EHS programs as assigned, promptly communicate deficiencies to management, maintain facility and work area in good working condition and work with team to ensure all aspects of business remain compliant. The QC Scientist II will edit documentation (i.e. Standard Operating Procedures, work instructions) as necessary. He/she will perform/assist in the completion and documentation of the process steps as per the documentation directives; complete visual verification of the process and document these steps in the appropriate system and document all activities per the GMP requirements.
Qualifications
A Bachelor’s Degree in Chemistry, Biology or related science is required. A minimum of 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required. Knowledge/exposure of a LIMS system is preferred. Experience with Annual Product Reviews is required. Experience with statistical analysis and metrics is required. Proficiency with Microsoft Office – Word, Excel – is required. Experience with an electronic tracking system is required. Exposure to and a working knowledge of electronic batch records and/or other automated processes/systems is required. Working knowledge of SAP or ERP system is preferred.
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-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: 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.
QC Scientist II-8717140114
Description
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. is currently recruiting a QC Scientist II, to be located in Fort Washington, PA.
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 provides testing, technical and troubleshooting support in the QC laboratories. 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). 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. Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data. Performs statistical analysis in support of APRs, Stability, and Product Release. Complies with cGMPs, safety training and regulations. Performs more advance technical projects under the supervision of management. Maintains an environment of respect and teamwork with all coworkers.
The QC Scientist II will perform under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines. The will provide support during regulatory inspections /audits as directed. Support may be in the form of scribes, runner, and document gathering. He/she will attend GMP training on the schedule designated for the role and as appropriate for the role. The QC Scientist may provide statistical analysis in support of the APR and Stability processes. The individual will embrace a behavior of employee involvement and commitment to doing the job right the first time. He/she will have a strong working GMP knowledge. Communicates and identifies GMP gaps and can participate in all types of audits & Inspections. The QC Scientist II leads areas in ensuring all operations (processes) are completed in a compliant and safe manner and assists in coordination efforts in case of emergency- spill, fire etc. The individual will take necessary action to eliminate and immediately address safety hazards. Communicate any observed unsafe behaviors immediately. He/she will understand the safety concerns and promotes a safety conscience culture for their job function and wear the appropriate PPE when working in manufacturing and other hazardous working environments and advocates standards of safety. The individual will contribute to and attend all EHS programs as assigned, promptly communicate deficiencies to management, maintain facility and work area in good working condition and work with team to ensure all aspects of business remain compliant. The QC Scientist II will edit documentation (i.e. Standard Operating Procedures, work instructions) as necessary. He/she will perform/assist in the completion and documentation of the process steps as per the documentation directives; complete visual verification of the process and document these steps in the appropriate system and document all activities per the GMP requirements.
Qualifications
A Bachelor’s Degree in Chemistry, Biology or related science is required. A minimum of 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required. Knowledge/exposure of a LIMS system is preferred. Experience with Annual Product Reviews is required. Experience with statistical analysis and metrics is required. Proficiency with Microsoft Office – Word, Excel – is required. Experience with an electronic tracking system is required. Exposure to and a working knowledge of electronic batch records and/or other automated processes/systems is required. Working knowledge of SAP or ERP system is preferred.
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-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: 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.