QA Auditor - Parenterals

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for QA Auditor, Parenterals to be located at Gurabo, PR.

The QA Auditor Parenterals ensures that the product or service meets the established standards of quality in areas such as reliability, usability, and performance. Additionally, ensures that the performance of Process and Facility Quality Audits in Parenteral Manufacturing and Utility Areas is documented in accordance with established procedures, cGMP, and J&J standards.

Key Responsibilities:

• Perform and document Process and Facility Quality Audits in Parenteral Manufacturing and Utility Areas according to established Procedures, cGMP, and J&J Standards.

• Evaluate audit findings and collaborate with supervisor to implement appropriate corrective actions.

• Coordinate and conduct AQL Inspections to ensure the quality of finished Parenteral Products, monitoring testing and inspection of materials and products.

• Review batch records, in-process documents, analytical data, and other regulatory documentation to ensure compliance with Procedures, cGMP, and J&J Standards.

• Organize and maintain filing of batch records, in-process documents, analytical data, checklists, etc. for easy retrieval.

• Collect and compile statistical quality data as requested by the QA Supervisor.

• Review and/or approve Quality Assurance, Manufacturing, and Engineering SOPs, WIs, and Forms using the Documentation Management System.

• Perform SAP transactions to ensure proper inventory practices of Parenteral Manufacturing Materials according to established Procedures, cGMP, and J&J Standards.

• Promote a safe environment by ensuring equipment and process designs comply with Janssen Gurabo quality and safety procedures, as well as national and local regulations.

• Collect related product samples according to batch record requirements.

• Support the Quality Assurance Sr. Supervisor in achieving Company and QA Area/Department goals and objectives.

• Provide compliance support to Manufacturing and Packaging Operations to ensure adherence to cGMPs, J&J Global Standards, Company Policies, Quality Agreements, Batch Records, specifications, and procedures.

• Evaluate current operating procedures and make recommendations to optimize quality oversight and production activities.

• Prepare reports to communicate quality activity outcomes, such as Shift Report and Documentation Error Trending Report, etc.

• Complete training in Enterprise Learning Management System (ELMS) within the designated timeframe.

• Improve the manufacturing batch record documentation process to ensure compliance with regulatory agencies and J&J Standards, using quality indicators.

• Provide QA support for complaint investigations and review Change Control related to processes.

Qualifications:

• A bachelor's degree in science is required, with a preference for a major in Microbiology, Biology, Chemistry, or a related field

• Minimum of two (2) years of experience in a related field

• Flexibility to work any day, any shift, (long hours, holidays and weekends) if required

• This position may require up to a 10% domestic travel

• Work in an aseptic area where full gowning is required

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills: