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Quality Specialist III

Parsippany, NJ 07054

Posted: 03/30/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 556030 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 60-80/hr **salary will be commensurate with experience 

Job Description:
  • Complete required internal training on client's System Development Lifecycle (SDLC), Business SOPs, etc. related to the systems in scope.
  • 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 Quality Global Business Owner.
  • 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.
  • 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.
  • Participate in developing and implementing global, harmonization guidances/SOPs and templates to enhance use of the Quality Control systems and improve corporate-wide compliance.
  • Additional activities per Managers request
  • The following qualifications are required:
  • Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field
  • (Most important) 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.
  • In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices
  • Knowledge of cGxP requirements and Quality related IT applications
  • Experience with computer system validation
  • Experience in regional and/or global role preferred

Qualifications:
  • (Most important) 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.
  • Ability to translate the operational needs of the business to the technical computer system requirements.
  • In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices
  • Knowledge of cGxP requirements and Quality related IT applications
  • Experience with computer system validation
  • Experience in regional and/or global role preferred
  • Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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