Líder Johnson & Johnson Consumer Healthcare is recruiting for a QA Operations Associate II, 3rd Shift to be located in Las Piedras, Puerto Rico.
Johnson & Johnson Consumer Inc., based in Las Piedras, PR, is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Understanding of all applicable McNeil processes, specifications, and Quality functions, the QA Operations Associate II provides daily quality support to the Manufacturing floor. Executes on line quality review of electronic batch records (e-BR) and GMP documentation. Pursues solutions of situations following procedures and cGMPs. Identifies, notifies and supports the settle of Shop Floor issues. Maintains the highest level of compliance with cGMPs and McNeil’s standards and procedures. Dispatches and Returns printed material label. Monitors storage conditions and maintenance of the Label Room area.
You will:
• Review the electronic manufacturing and packaging controlled documentation and supporting documents to ensure procedural and cGMP compliance.
• Identify and resolve situations related to batch record review in a timely manner.
• Provide cGMP mentorship at the Shop Floor including the Participates in projects and special company activities in representation of the Quality Unit as delegated. Prepare, keep records, and document required information and or activities following established procedures.
• Develop and revise operational procedures as the need arises.
• Conduct cGMP walkthrough audits as per established procedure.
• Provides follow up on corrective and preventive actions related to Quality Assurance. Provide ideas and improvements supporting the prevention of undesired situations.
• Execute post-production and investigational statistical sampling.
• Communicate direct (primary in English) with regulatory agencies to discuss procedures, e BRR or SAP transactions.
• Update and perform product status changes in the electronic inventory control system and assigns disposition to the product between the assigned stages.
• Serve as a back-up for the disposition of packaging components.
Qualifications
• A minimum of a Bachelor’s of Science in Chemistry, Pharmacy, Microbiology, Biology or Engineering is required.
• A minimum of two (2) years of experience in quality assurance, quality control or solid dosage manufacturing is required.
• Ability to interpret and apply current Good Manufacturing Practices.
• Mathematics skills and analytical ability is required.
• Basic computer knowledge (MS software - Excel, PowerPoint, Word) is required.
• Basic skills in SAP inventory system transactions is required.
• Knowledge and skills in validation processes and statistical process control, detection, correction and error prevention, process system challenges, knowledge of sampling process, audits, root cause analysis and risk management is preferred.
• Takes decisions based on available facts while meeting established date and priorities. Validated leadership.
• Proficient in the latest quality assurance techniques. Works with minimum supervision and under stressful. Takes initiative and makes good judgment in the performance of duties. Communicates efficiently with personnel.
• Bilingual (English and Spanish) with excellent verbal, writing and technical writing skills in both languages is highly preferred.
• Available to work third (3rd) shift and in other areas, according to business strategies.
• Able to work extra hours and to respond to emergency calls that require returning to the company, and to work alternate shifts.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location
United States-Puerto Rico-Las Piedras- Organization
McNeil Healthcare LLC (7598)
Job Function
Quality
Requisition ID
2105892295W
