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University of Rochester Quality Tech Assoc I, Stem Cell CGMP Clin Lab - 218861 in Rochester, New York

Quality Tech Assoc I, Stem Cell CGMP Clin Lab Job ID 218861

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 051 Microbiology & Immunology M&D

Schedule

8 AM-4:30 PM; OCC WKENDS/HOL

Responsibilities

Position Summary:

The Quality Control (QC) Associate I will be a member of the Microbiology and the Upstate Stem Cell cGMP Facility (USCGF) teams. The QC Associate will be responsible for upholding in-process and final release analysis of cancer immunotherapy cell products. This will be required to work in adherence to applicable FDA regulations, standards, and internal policies and procedures.

Responsibilities:

Under limited guidance of the Director of Clinical Microbiology and Executive Director of the USCGF, with latitude for independent technical judgment, specific responsibilities will include, but will not be limited to:

  • Conducting in-process and final release analysis on product in compliance to regulatory standards USP 71. Microbiology analysis includes Gram stain, Endotoxin and Sterility Culture. Testing involves set-up, execution, data analysis, and reporting of results. This task will be carried out at the Clinical Lab under the guidance of the Director of the Clinical Microbiology Lab.

  • Testing of mycoplasma and ELISA analysis for in-process and final release analysis on product. Testing involves set-up, execution, data analysis, and reporting of results. This task will be carried out at the GMP Quality Control Lab under the Guidance of Executive Director of USCGF.

  • Releasing raw materials for use in production and Quality Control processes. Reviewing and obtaining lot-specific Certificates of Analysis, reviewing results and labeling containers. This person will ensure that results are reported in a timely manner to the QA Director of the cGMP Facility, therefore interacting and communicating with staff in Clinical Microbiology and with staff in of the Stem Cell CGMP facility

  • Developing and implementing standard operating procedures (SOPs) and conducting ongoing review and improvement of facility SOPs.

  • Ensuring quality system records are adequately backed up and maintained in OnBase or other venue

  • Other projects and duties as assigned.

    Qualifications:

    Bachelor's degree with major course work in field of assignment, and 1 year of related work experience involving direct assistance to researchers; or any equivalent combination of experience, training and education.

    Preferred Qualifications

  • 4-5 years’ related experience and working knowledge of the Food and Drug Administration ( FDA) and GMP (Good Manufacturing Practices) is preferred.

  • Experience as a Clinical Technologist is desirable.

  • Strong attention to detail and ability to manage multiple projects and priorities.

  • Excellent interpersonal, oral and written communication skills.

  • Ability to work both independently and in a team environment.

  • Comfortable working in an FDA-regulated environment.

    How To Apply

All applicants must apply online.

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