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Quality Specialist - II (Associate)

Rahway, NJ 07065

Posted: 05/30/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 567413 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 30-45.86/hr **salary will be commensurate with experience 

Job Description:

Department is responsible for starting up new clinical manufacturing facility for sterile products and is seeking a strong quality professional to perform the below tasks:
  • The primary role of this position is to support Operational Readiness of the new Research Labs sterile clinical manufacturing facility in Rahway, NJ.
  • The individual will work closely with Operations partners to develop processes and procedures which meet all internal and external quality and compliance requirements.
  • A core part of this position is to serve in the lead (or co-lead) role for Quality Risk Assessments.
  • As the lead/co-lead, the individual will work with Operations partners to develop the Plan for each risk assessment. They will then schedule and run cross-functional risk assessment meetings.
  • As the lead/co-lead, they will be responsible for reporting the outcomes of the risk assessment. This includes a written report(risk assessment) and a presentation to the appropriate Decision Makers.
  • The individual will support other aspects of Operational Readiness, as it pertains to quality deliverables. This may include authoring or reviewing documents like SOPs, training materials etc. It may also include designing and/or utilizing project management tools to track progress.
  • The role will require some on-site presence at the Rahway site, primarily for leading face-to-face meetings (e.g., risk assessments).

Qualifications:

Education: • Bachelor's of Science or Master's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience. Required Experience and Skills: • At-least 4years of relevant experience with BS and 2+ years with Master's. • Need an individual with either Project Management experience, Quality Risk Management experience, or preferably both. Software: MS office(Basic) Personality: • Team Player • Strong communicator(verbal and written) • Detail oriented • Someone who can value listening to multiple perspectives. • Strong time management skills • Can manage Multiple deliverables at one time.

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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