HireDiversity

Lancaster, PA, US

DEVIATION INVESTIGATOR II-7338121016

Description

McNeil Consumer Healthcare, a member of Johnson & Johnson's Family of Companies, is recruiting for a Deviations Investigator 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, PediaCare® upper respiratory medicines for infants and children, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants.

Deviation Investigator will ensure compliance assurance by leading investigations, and determining corrective actions for site manufacturing operation departments. As part of this role, the investigator will review training records, calibration records, PM records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents. Assist other Deviations Investigators with data collection, data review, process improvements.

The Deviation Investigator will be responsible to author deviation investigations, and formulate CAPA's associated with the event. Ensures all investigations are drafted to meet site specified timelines and are completed prior to release of associated product(s). Will perform and understand investigation trending in order to determine appropriate CAPA's in response to trends. Ensures investigation metrics and trends are available for presentation during regulatory inspections and inclusion in APRs.

The Deviation Investigator will assist in managing all level 2 manufacturing operation deviation investigations and CAPA implementations. 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. Participates in daily event meetings providing updates and follow-ups to manage process & schedule. Must build relationships with the QA Release group and Operations to determine/understand their needs and build trust/confidence in order to resolve investigations. Will assist in the site internal audit program when required. Works 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. Ensures site SOPs accurately reflect the investigation process and update as necessary. Assists in resolution of roadblocks that prevent optimal effectiveness of the investigation process.

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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 B.S or B.A degree is required, preferably in a technical discipline such as Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy or related major. At least 1 year experience in a pharmaceutical and/or biological manufacturing operation is required. Experience investigating manufacturing deviations, investigations and events either in a QA or manufacturing role is preferred. Working knowledge in one or all of the following is required: pharmaceutical facilities, equipment, laboratories and systems.

Experience with LIMS, SAP-QM, is an asset. EtQ and/or Trackwise experience is preferred.

Demonstrated Lean / Six Sigma knowledge is preferred. Experience with Microsoft based Office applications is required. Strong written communication skills desired. Root Cause Analysis experience is desired.

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)