QA Specialist Quality System Complaints

Job description

Job Description

Requisition ID: 1823190104

Janssen - Cilag Mfg LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Specialist Quality System Complaints to be in Gurabo, PR.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us Janssen - Cilag Mfg LLC is part of the Janssen Pharmaceutical Companies.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

As the QA Specialist Quality System Complaints, you will:

·  Be accountable to ensure that all external customer complaints and internal complaints from affiliates are handled, evaluated, investigated and documented in a timely and effective manner, in conformance with cGMP's, GPSG Policies and Procedures.
·  Monitor monthly metrics of Complaints such as compliance with the schedule, cycle time and drill down of major contributors.
·  Ensure that all record keeping requirements and internal documentation needs are according to established procedures and cGMPs.
·  Actively participate in projects, programs, safety and environmental training, c-GMP, SOPs, and others as required and/or special activities that the company promotes to develop employee involvement and their professional development/growth.
·  Ability to handle multiple tasks at the same time and efficiently interact and work with multiple processes, departments and across JSC site.
·  Active participation in Credo initiatives.
·  Be available to support and expedite emergency changes on non-business hours/days.
·  See opportunities to harmonize processes, improve the quality of processes and streamline processes.
·  Create a progressive monitoring process to ensure compliance of process, documentation and see opportunities for improvement and streamlining.
·  Participate regularly with management team to identify solutions to common issues and prioritize solutions.

Desired profile

Qualifications

·  A minimum of a Bachelor's Degree in Science required. A Bachelors Degree in any of the following fields: Chemistry, Pharmacy, Microbiology, Biology, or Engineering is preferred.
·  A minimum of two (2) years of experience in related areas in the pharmaceutical industry.
·  Profiecient knowledge in the use of Microsoft office (Excel, Word, and PowerPoint) is required. Knowledge in Trackwise system is preferred.
·  Strong knowledge in FDA and International Regulatory Requirements is required.
·  Knowledge in the QA Compliance Areas with comprehensive understanding of domestic and international guidelines is required.
·  Knowledge in cGMPs and pharmaceutical manufacturing & packaging, and quality control activities for different dosage forms types is required.
·  Technical Writing skills is required.
·  Participate regularly with management team to identify solutions to common issues and prioritize solutions.
·  Good interpersonal skills, the ability to manage complexity and conflict.
·  Strong problem solving and decision-making skills and the ability to influence others regarding quality goals
·  Proficiency in both languages English and Spanish (oral and written) is required.
·  This position requires up to ten percent (10%) of domestic travel.
·  Ability to work extra hours, at night or on weekends and irregular shifts is required.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any

Primary Location
United States-Puerto Rico-Gurabo-
Organization
Janssen - Cilag Mfg LLC (8427)
Job Function
Quality (Generalist)
Requisition ID
1823190104