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Senior Manufacturing Investigators (2 openings)-2504130228
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting two (2) Senior Manufacturing Investigators, located in Las Piedras, Puerto Rico.
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, MOTRIN® IB, ROLAIDS® antacid products, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J's Family of Companies or beyond, or whether this is your entry to the J&J's Family of Companies, we invite you to join us…. Creating the future of McNeil.
The selected person will be responsible for performing investigations Level I, Level 2 and Customer Complaint. This individual will author investigations (deviation/nonconformance and/or complaint) and formulate CAPA's associated with the event, if required. Ensure and coordinate involvement of cross functional teams with appropriate expertise. The Investigator will work closely with cross functional partners to remediate events and/or CAPA's necessary to close out the investigation. The Investigator will ensure all investigations are drafted to meet site specified timelines and are completed prior to release of associated product(s), if product impacted. When necessary based on the investigation to be performed, this individual will ensure and coordinate involvement of cross functional teams with appropriate expertise. The Investigator will ensure site SOPs accurately reflect the investigation process and update as necessary; assist in resolution of roadblocks that prevent optimal effectiveness of the investigation process; and will work with other corporate units as required. 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.
A minimum of a Bachelor's Degree is required, a major in Science is highly preferred. Must have at least five (5) years of overall experience within the pharmaceutical industry. A minimum of two (2) years of experience working in a similar role (performing investigations) is required. Strong knowledge of solid dosage process is required. Must have experience in customer complaints. Fully Bilingual (English & Spanish) is required. Must be knowledgeable in GMP and pharmaceutical industry applicable regulations. Strong experience in MS Office software applications (MS Outlook, Excel, PowerPoint & Word) is a plus. Knowledge in SAP is preferred. Must be able to travel in and outside of Puerto Rico, work extra hours and to respond to emergency calls that require returning to the company after regular working hours, if necessary.
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Primary Location: North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Travel: Yes, 10% of the time
Job Function: Process Engineering
Johnson & Johnson Family of Companies - 9 months ago
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