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Quality Analyst

Careerbuilder-US

This is a Full-time position in Rochester, NY posted October 23, 2021.

Title:- Quality Analyst

Duration:- 6 months

Location:- Rochester, NY

Schedule: 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 Ortho 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.
  • The Opportunity As the company continues to grow, we are seeking a SPQC Quality Analyst I.
  • This SPQC Quality Analyst 1 position is in Company’s Operational Quality Laboratories in Rochester, NY.

Job Requirements:

The 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).