HireDiversity

Raritan, NJ, US

Senior QA Associate-7479130109

Description

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

The Sr. QA Associate provides general QA technical support for external manufacturers in accordance with JSG standards. This may include, but is not limited to: 1) Reviewing batch documentation and performing product release, 2) Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation, 3) Collecting manufacturing data to analyze trends and preparing reports as required, 4) Developing corrective action plans and monitoring implementation, 5) Participating in quality audits at external manufacturers, 6) Conducting and participating in manufacturing investigations, 7) Writing and implementing quality procedures, 8) Suggesting improvements of existing manufacturing processes, 9)Providing QA support for technology transfers. This position will contribute to the overall development, implementation, and execution of quality systems in support of the manufacture of (bio)pharmaceutical products.

The Sr. QA Associate will also provide support to manufacturing/logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing. This individual will remain current with FDA/EU regulations, guidelines, and quality practices associated with the pharmaceutical industry.

Qualifications


Bachelor's Degree with a minimum of 5 years experience in an FDA-regulated environment is required. Experience working in a pharmaceutical/biologics manufacturing or quality environment is preferred. Experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred. The ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues is required. Experience investigating customer Product Quality Complaints is required. Experience with Six Sigma or Lean Manufacturing process is preferred. Proficiency in computer applications such as the MS Office suite is required. Strong communication and organization skills are required. This position can be based in Raritan, NJ or Horsham, PA and requires a minimum of 10% travel to contract manufacturer sites.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Horsham
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Assurance