Quality Assurance Auditor - Parenterals - Full-time

Janssen Cilag LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Assurance Auditor, Parenteral to be located at Gurabo, PR!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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:

• Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to address potential compliance issues in a proactive way in order to deliver product on time. Make the appropriate recommendations and decisions to prevent process and/or product deviations.
• Perform and document Process and Facility Quality Audit in a Parenteral Manufacturing/ Packaging and Utility Areas according to established Procedures, cGMP and J&J Standards.
• 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/ Combination Product Products and oversight the inspection of materials and products to ensure finished product quality.
• 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.
• 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.
• 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.
• Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing and Packaging Materials according to the established standards.

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:

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

Preferred:

• Knowledge or experience in Pharmaceutical/Parenteral manufacturing and Packaging process
• Knowledge in current systems such as but not limited to SAP, Compliance Wire, Documentation System, Investigation System, LIMS
• Certified Quality Auditor (CQA), Yellow/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 second or third shift, including irregular (non-standard) shifts and weekends.
• This position may require up to 10% of domestic 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.

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.