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Quality Specialist Jobs

Company

Stefanini, Inc
Address , Parsippany, 07054, Nj
Employment type CONTRACTOR
Salary $156,000 - $166,400 a year
Expires 2023-06-23
Posted at 1 year ago
Job Description
Stefanini Group is hiring!
Stefanini is looking for Quality Specialist III at Parsippany, NJ Location
For quick Apply, please reach out to Shubham Singh - call: 248-728-2629 email: [email protected]
Work shift (days/times) - M-F (40 hours)
Work Location - Parsippany, NJ
Shift: Monday - Friday 8:00am - 5:00pm. 40 hours a week. Min 3 days in office and 2 from home.
:
  • Participate in system change request/release review and prioritization meetings with counterparts in Information Technology (IT), Compliance, sites, and other internal Client functions as delegate Global Business Owner.
  • Additional activities per Manager's request
  • Participate in developing and implementing global, harmonization guidance/SOPs and templates to enhance use of the Quality Control systems and improve corporate-wide compliance.
  • Serve as a delegate Quality Global Business Owner for LIMS, Empower 3, and other Global Quality computer systems as assigned, under the leadership of the Client Quality Global Business Owner.
  • Complete required internal training on Client's System Development Lifecycle (SDLC), Business SOPs, etc. related to the systems in scope.
  • Review and approval of system project and validation documentation as delegate Global Business Owner. This activity requires knowledge of computer system validation deliverable requirements, the core systems in scope (Labware LIMS, Waters Empower 3 CDS), and ability to translate the operational needs of the business to the technical computer system requirements.


Qualification:
  • Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field
  • Knowledge of cGxP requirements and Quality related IT applications
  • Experience with computer system validation
  • Ability to translate the operational needs of the business to the technical computer system requirements.
  • Minimum of 5 years in pharmaceutical industry or related industry. Two or more years as a business owner with LIMS and/or laboratory data capture software is required.
  • Experience in regional and/or global role preferred
  • In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices
***Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.