- 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.
- 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.
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Quality Tech Assoc I, Stem Cell CGMP Clin Lab - Rochester, United States - University of Rochester
Description
ResponsibilitiesPosition Summary:
The Quality Control (QC) Associate I will be a member of the Microbiology and the Upstate Stem Cell cGMP Facility (USCGF) teams.
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:
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.
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.
_Apply for Job
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening:
Schedule: