Job Information
University of Rochester Quality Tech Assoc I, Stem Cell CGMP Clin Lab in Rochester, New York
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.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $ 37,000 - $ 64,100 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
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