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Quality Analytical Laboratory Manager
McNeil Healthcare LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Analytical Laboratory Manager!
Johnson & Johnson Consumer Inc. 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.
Are you interested in joining a team that is helping improve customer care and drive innovation? Apply today!
Responsible for ensuring that the operations of the Analytical Laboratory and the Stability Group comply with company and regulatory agencies’ regulations regarding the manufacturing of our products.
Coordinates the most effective use of the laboratory resources to manage the analysis of raw materials, water, bulk intermediates, stability and final product.
Coordinates the most effective use of the Stability Group to manage the Marketed Product Stability (MPS) Program.
Develops, coordinates and controls the budget of the Analytical Laboratory.
Provides technical leadership towards the identification of the causes for non-conformances and process’ failures, and for the implementation of the remedial, corrective and preventive actions.
Supports the review and approval of investigations, Change Control or technical documents when required.
Prepares, maintains and reports metrics at site/external forums such as Quality Council, Governances, etc. Assists in resolution of roadblocks that prevent optimal effectiveness of assignments.
Actively participates in regulatory inspections and internal audits.
Serves as back-up to the Microbiology Laboratory Manager as required.
Bachelor’s or higher degree in Chemistry is required. A post-graduate study is preferable.
Experience and Skills:
A minimum of 8 years of overall working experience
At least 5 years of working experience in a Quality Assurance and/or Quality Control department in the pharmaceutical industry
PR Chemist License or other national certification
Knowledge in solid dosage process in pharmaceutical industry
Experience in the review/approval of Investigations and Change Control.
Knowledge in GMPs, analytical techniques, stability programs and working in manufacturing areas of a pharmaceutical company
Knowledge of the HPLC, GC, and UV technologies
Experience in operation of contracted laboratory services and the manufacturing of solid dosage in a regulated environment
Green Belt Certification
Project Management, JJPS and/or Process Excellence knowledge
Experience in regulatory audit management
Computer and laboratory equipment validation knowledge
Proficiency in computerized systems (Excel, PowerPoint, Word, LIMS, SAP)
Able to travel in and outside of Puerto Rico approximately 10% of the time
Able to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business
Able to support other departments and/or projects according to business needs
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
Primary Location United States-Puerto Rico-Las Piedras- Organization McNeil Healthcare LLC (7598) Job Function Quality Requisition ID 2206079165W