iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.
With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. What You Will Do The QA Associate III - Investigations is accountable
to support the investigation and CAPA process that pertains to the QC laboratories, facilities, manufacturing and packaging operations in addition to guidance on compliance and Good Manufacturing Practice (GMP) to meet company procedures, standards and regulatory expectations.
This position provides daily direction, planning, decision making and compliance focus for the site consistent with Supply Chain Goals while meeting the compliance goals of Quality Assurance. Supports multiple functions in providing sound and timely decision making by utilizing root cause analysis, statistical, and problem-solving tools. Through the investigation process, this position will identify significant
compliance issues and prioritize for action. Lead and implement improvement opportunities and problem solutions.
Responsible for reviewing, approving, and ensuring investigations and CAPA are completed timely and in alignment with standard operating procedures. Responsible for the administration of investigation and CAPA systems, effectiveness, and continuous improvement of the Investigation /CAPA system at the Fort Washington site and Network / Global levels, as required. Responsible for administration of Investigation and CAPA metrics management and review board. Measures, tracks, trends and promotes improvement of process metrics. Ensures Investigation / CAPA Corrective and preventative Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (c GMP) regarding quality methods and manufacturing and packaging processes and procedures.
Ensures that the process meets all internal and regulatory quality standards. Key Responsibilities • Lead and facilitate investigations and relative improvement projects and initiatives identified root cause analyses. • Evaluate non-conformance investigations provided by functional areas assuring that all appropriate investigation steps were conducted and that appropriate corrective actions were devised where applicable.
• Consult with the functional areas to align c GMP requirements, company, and regulatory guidelines. • Maintain knowledge of regulatory environment, c GMPs, FDA policies and current industry trends. • Prepare and present written and verbal reports to upper management pertaining to investigation and CAPAs. • Participate in cross functional meetings related to investigations and CAPA and product disposition as applicable to identify daily challenges on compliance that affect the quality of the product. • Engage vendors in investigations that pertain to the quality of finishing supplies or raw materials and assure that corrective actions are devised where applicable.
• Author investigations and investigational protocols as required. • 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. • Ensure investigation metrics and trends are available for presentation during regulatory inspections and inclusion in APRs. • Author Annual Product Review contributions related to investigations and CAPA.
Review and approve APR contributions as required. • Assist in managing investigations and CAPA implementations. • Initiates deviations, performs root cause analysis, conduct investigations to backss impact on products and process, recommends product disposition and recommends change controls and CAPA's as needed. • Participate in daily/weekly event meetings providing updates and follow-up to manage process & schedule. • Interacts with QA Release group and Operations to determine/understand their needs in order to resolve investigations.
• Assist in the site internal audit program when required. • Work closely with the correction/CAPA owners to remediate events and/or corrections /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 accurately reflect the investigation process and update as necessary. • Assist in resolution of roadblocks that prevent optimal effectiveness of the investigation process. • Work with other corporate units as required. Qualifications What We Are Looking For Required Qualifications • B.
S or B. A is required. Degree in Microbiology, Biology, Virology, Biochemistry, Chemistry, Engineering or shop 3 years experience in a medical, OTC and/or biological manufacturing operation investigating manufacturing deviations, investigations and events either in a QA or manufacturing role is required. Working knowledge of medical facilities, equipment, laboratories and systems is required. Experience with statistical analyses tools is required. • Experience with Microsoft based Office applications is required. Desired Skills: • Strong written communication skills required • Demonstrated Lean / Six Sigma knowledge is preferred.
• Experience with LIMS, SAP-QM, and Et Q is preferred What's In It For You • Competitive Benefit Package • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More! • Learning & Development Opportunities • Employee Resource Groups Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
