CGMP Quality Analyst

CGMP Quality Analyst

25 Oct 2024
New York, Rochester, 14602 Rochester USA

CGMP Quality Analyst

Vacancy expired!

Please note that this is a 1 year contract position.
This position will be A or B shift (6am – 2:30pm or 1:30pm to 10:00pm) Tuesday – Saturday.
Qualifications:
BA/BS degree or equivalent is required; A degree with a science concentration is preferred. Previous laboratory or similar experience is required. Candidate must be willing to learn to run, maintain and troubleshoot Vitros 350, FS 5, 1, 4600 and 3400 analyzers. Candidate must have analytical knowledge required for production releases. Experience in Pharma LIMS or SAP is preferred but not required. Careful attention to detail and accuracy of work are required. As an FDA regulated facility, documentation is key to this position in order to meet regulatory requirements; therefore, candidate must have an understanding of cGMPs and documentation in a regulated industry. Experience in documentation protocols and procedures are a plus. Candidate must have a demonstrated proven track record of planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions. Having a working knowledge of computers and windows software is desired. Full understanding of quality control is expected. This position requires an individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting. This position requires working in a lab setting which includes standing for long periods of time and wearing personal protective equipment (PPE). Candidates are required to work in a BL2 Lab and handle human samples. This position is located in Rochester, NY.
Responsibilities: Executing release testing and data analysis for release of product. Individual will run, maintain, and troubleshoot Vitros 350, FS 5, 1, 4600 and 3400 analyzers. Work in partnership with manufacturing Operations, Product Support and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product. The individual will execute Vitros testing following Test Designs and analyze data for the release of product. Routinely interacts with data management systems such as LIMS, SAP, Document Management Systems (OTIS), and Non-Conformance & CAPAs (QERTS).
Applicants must provide their phone number. Reference job number A1181.

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Job Details

  • ID
    JC21700894
  • State
  • City
  • Job type
    Contract
  • Salary
    Depends on Experience
  • Hiring Company
    NetSource, Inc.
  • Date
    2021-10-22
  • Deadline
    2021-12-20
  • Category

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