Quality Assurance Validation Specialist III

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Validation Specialist III!

 

Johnson & Johnson Consumer Inc., based in Skillman, N.J., 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.

 

The QA Validation Specialist III is responsible for overseeing validation activities associated with manufacturing and lab equipment, mixing processes, packaging, cleaning, computer systems and lab methods to ensure all necessary procedures and regulatory guidelines are being followed. They are responsible for providing Quality Assurance leadership for lab and engineering projects through the validation lifecycle and work with the project teams to address any issues. They will also act as a QA lead to deliver site improvements, process efficiencies and new agile ways of working.

 

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

 

Key Responsibilities:

• Provide quality oversight to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, cleaning and laboratory method validation.
• Lead in the development, review and implementation of validation documents, quality and engineering procedures.
• Review and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes.
• Be the Quality lead in the development of the Master Validation Plans, Project Plans, and Test Plans.
• Provide guidance and oversee the maintenance of the validated state including periodic reviews and requalification/revalidation of equipment and processes.
• Initiate, review, and approve change controls/engineering change notices, investigations, discrepancies/deviations, and audit responses.
• Be the QA Validation SME (Subject Matter Expert) to understand the critical aspect of product, component and labeling requirements.
• Review and sign off on relevant documentation per the function (i.e. QA validation) as required by the quality process in the execution of the relevant work.
• Participate in internal and external site audits and audit preparation in support of validation documentation discussions.

Qualifications

• A minimum of a Bachelor’s degree (or equivalent degree) is required
• A minimum of 4 years of related experience within a GMP environment is required
• Ability to interpret and apply GMP requirements is required
• Strong knowledge of multiple validation disciplines is required
• Strong knowledge/understanding of the product development life cycle is required
• Strong knowledge/understanding of drug manufacturing and packaging processes from sampling and inspection through warehouse distribution is preferred
• Intermediate/Expert user in various computer systems: ERP, LIMS, MES and Microsoft Office (including Outlook, Word, Project, Excel, PowerPoint) is preferred
• A degree focused in Science, Computer Science or Engineering is preferred
• Intermediate understanding of PLC programs and manufacturing/laboratory system software applications is preferred
• This position will be located in Fort Washington, PA and may require up to 5% travel

 

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.

Primary Location
United States-Pennsylvania-Fort Washington-7050 Camp Hill Road
Organization
Johnson & Johnson Consumer Inc. (6101)
Job Function
Quality
Requisition ID
2105990088W

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