Deviation Investigator II Job
Company Name:
McNeil-PPC, Inc. (6101)
Lancaster, PA, US
Johnson & Johnson companies are equal opportunity employers.
Deviation Investigator II
Description
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Deviation Investigator II located in Lancaster, 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 Deviation Investigator II will ensure compliance assurance by leading Level II investigations, Level I investigations with mentoring, determine corrective actions for site manufacturing operations and quality systems operations. The Deviation Investigator Level II will also author compliant investigations to help drive root cause and meet due dates. The Deviation Investigator author's level II deviation investigations, Level I investigations with mentoring, complaint investigations and formulate CAPA's associated with the event. Assist other deviation investigators with data gathering and review to meet investigation timelines. Ensure all investigations are drafted to meet site specified timelines and are completed prior to release of associated product(s). Perform and understand investigation trending in order to determine appropriate CAPA's in response to trends. Assist in managing all manufacturing operation deviation investigations and CAPA implementations. Initiates manufacturing deviations, performs root cause analysis, conduct investigations to assess impact on products and process, recommends product disposition and recommends change controls and CAPA's as needed. Participate in daily event meetings providing updates and follow-up to manage process & schedule. Build relationships with the QA Release group and Operations to determine/understand their needs and build trust/confidence in order to resolve investigations. Assist in the site internal audit program when required. Work closely with the QA CAPA specialists to remediate events and/or CAPA's necessary to close out the investigation. When necessary based on the investigation to be performed, ensure and coordinate involvement of cross functional teams with appropriate expertise. Ensure site SOPs accuratelyreflect the investigation process and update as necessary. Assist in resolution of roadblocks that prevent optimal effectiveness of the investigation process.
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 B.S or B.A in a technical discipline is required. A focus degree is Microbiology, Biology/Virology, Biochemistry, Chemistry is preferred. A minimum of 1 year experience in a pharmaceutical and/or biological manufacturing operation investigating manufacturing deviations, investigations and events either in a QA or manufacturing role required. A working knowledge of one of these areas is required: pharmaceutical, equipment, laboratories and systems . Experience with LIMS, EtQ and Trackwise is preferred. Demonstrated Lean / Six Sigma knowledge preferred. Previous work experience with pharmaceutical and/or sterile dosage forms and/or manufacturing packaging is required. Previous experience with a pharmaceutical and/or biologics manufacturing facility is also required. Experience with Microsoft based Office applications required. Strong written communication skills required. This position will be located in Lancaster, Pa.
Primary Location:
North America-United States-Pennsylvania-Lancaster
Organization:
McNeil-PPC, Inc. (6101)
Job Function:
Quality Assurance
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 SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
McNeil-PPC, Inc. (6101)
Lancaster, PA, US
Johnson & Johnson companies are equal opportunity employers.
Deviation Investigator II
Description
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Deviation Investigator II located in Lancaster, 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 Deviation Investigator II will ensure compliance assurance by leading Level II investigations, Level I investigations with mentoring, determine corrective actions for site manufacturing operations and quality systems operations. The Deviation Investigator Level II will also author compliant investigations to help drive root cause and meet due dates. The Deviation Investigator author's level II deviation investigations, Level I investigations with mentoring, complaint investigations and formulate CAPA's associated with the event. Assist other deviation investigators with data gathering and review to meet investigation timelines. Ensure all investigations are drafted to meet site specified timelines and are completed prior to release of associated product(s). Perform and understand investigation trending in order to determine appropriate CAPA's in response to trends. Assist in managing all manufacturing operation deviation investigations and CAPA implementations. Initiates manufacturing deviations, performs root cause analysis, conduct investigations to assess impact on products and process, recommends product disposition and recommends change controls and CAPA's as needed. Participate in daily event meetings providing updates and follow-up to manage process & schedule. Build relationships with the QA Release group and Operations to determine/understand their needs and build trust/confidence in order to resolve investigations. Assist in the site internal audit program when required. Work closely with the QA CAPA specialists to remediate events and/or CAPA's necessary to close out the investigation. When necessary based on the investigation to be performed, ensure and coordinate involvement of cross functional teams with appropriate expertise. Ensure site SOPs accuratelyreflect the investigation process and update as necessary. Assist in resolution of roadblocks that prevent optimal effectiveness of the investigation process.
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 B.S or B.A in a technical discipline is required. A focus degree is Microbiology, Biology/Virology, Biochemistry, Chemistry is preferred. A minimum of 1 year experience in a pharmaceutical and/or biological manufacturing operation investigating manufacturing deviations, investigations and events either in a QA or manufacturing role required. A working knowledge of one of these areas is required: pharmaceutical, equipment, laboratories and systems . Experience with LIMS, EtQ and Trackwise is preferred. Demonstrated Lean / Six Sigma knowledge preferred. Previous work experience with pharmaceutical and/or sterile dosage forms and/or manufacturing packaging is required. Previous experience with a pharmaceutical and/or biologics manufacturing facility is also required. Experience with Microsoft based Office applications required. Strong written communication skills required. This position will be located in Lancaster, Pa.
Primary Location:
North America-United States-Pennsylvania-Lancaster
Organization:
McNeil-PPC, Inc. (6101)
Job Function:
Quality Assurance
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 SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
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