Quality Assurance Auditor- Parenterals, 3Rd Shift

Janssen Cilag LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Assurance Auditor- Parenterals!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and sophisticated diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients encourage us. We collaborate with the world for the health of everyone in it.

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

As the QA Auditor, you will be accountable for ensuring the compliance with material specifications, current Good Manufacturing Practices, written procedures, Company Global Standards and Quality Agreements during batch record review related to the manufacturing and/or packaging of a product, comprehending raw materials, drug substances, finished product, and packaging components for Parenteral-Large Molecules Area.

Key Responsibilities:

• Assure, prior conducting certification of a batch, that all regulated items established by current procedures, current specifications, quality agreements or customers are considered. Ensure all related documentation and samples for the specific stage have been taken and been indicated accordingly in Batch record documentation.
• Coordinate and conduct AQL Inspection to finish Parenteral Products and oversight the inspection of materials and products to ensure finished product quality.
• Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing Materials according to the established standards.
• Support the cycle time reduction in batch records review and release. Assure that products are approved on time and to minimize product backorder situations related to Product Disposition performance and to optimize quality oversight and production activities.
• Perform and document Process and Facility Quality Audit in a Parenteral Manufacturing and Utility Areas according to established Procedures, cGMP, and J&J Standards.
• Provide immediate actions and support in the timely resolution of quality and compliance matters that may include product segregation, product recalls and product approval/rejection.
• Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to address potential compliance issues in a proactive way to deliver product on time. Make the appropriate recommendations and decisions to prevent process and/or product deviations.
• Provides compliance support to Manufacturing and Packaging Operations to assure execution in compliance with cGMPs, Company J&J Global Standards, Company Policies, Quality Agreements, Batch Records, current specifications, and current procedures.

Qualifications

Education:

• A minimum of Bachelor's degree is required. Focused degree in Microbiology, Biology, Chemistry, or related science is preferred

Experience and Skills:

Required:

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint)
• Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols
• Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost, and critical success factors.
• At least 2 years of overall work experience

Preferred:

• Knowledge in current systems such as but not limited to SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), LIMS
• Knowledge or experience in Parenteral manufacturing process
• Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications

Other:

• Proficiency in both languages English and Spanish (oral and written) is required.
• This position requires availability for working third shift, including irregular (non-standard) shifts and weekends.
• Ability to travel domestic up to 10% of the time

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 .]