Professional Research Assistant-Quality Control Analyst
Professional Research Assistant
Working title: Quality Control Analyst - Professional Research Assistant –
Gates Biomanufacturing Facility
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The Charles C. Gates Center for Regenerative Medicine has an opening for a full-time Professional Research Assistant at the newly established Gates Biomanufacturing Facility. The Gates Biomanufacturing Facility is an academic cGMP contract manufacturing facility dedicated to the development and manufacture of novel biological therapies for early phase human clinical trials. This position will be responsible for the day to day Quality Control testing at the Gates Biomanufacturing Facility and will be focused on protein and cellular therapy analytical testing.The University of Colorado Denver seeks a Quality Control Analyst to work in the Gates Biomanufacturing Facility located near the Anschutz Medical Campus in Aurora. The University of Colorado Denver is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. The university has proudly positioned itself as one of the top urban research universities in the country. The Gates Biomanufacturing Facility is one of the core facilities used to differentiate the university in both regenerative medicines as well as traditional biotech streams. Job Information:
- Full time entry-level position at the Gates Biomanufacturing Facility located nearby the Anschutz Medical Campus. The position may require weekend work and work outside of normal work hours to accommodate the completion of release testing or other critical processes which cross shifts. While not typical, this irregularity of work hours should be expected.Perform routine analytical testing and routine facility environmental monitoring in a multidisciplinary laboratory space. Support of analytical development, qualification and release testing of protein biologics and regenerative medicine therapies.
- All wrk will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory.This psition may support method development.This psition will nt supprt any academic research.
- This role will have the following responsibilities including but not limited to the following:Water sampling in a GMP facility (Ttal Organic Carbon, Conductivity, Bioburden, Endotoxin)Nn-viable air testingViable air testingSurface testingGeneral analytical testing (UV-Vis, pH, Osmlality, CBC, and Endotoxin)Qualificatin and/or verification of analytical methodsAssist in prcess development work as needed
- Refine and implement key laboratory and analytical SOPs in the QC lab.Peer review Quality Control analytical data packets.
- Perform preventative maintenance on analytical equipment, as needed.Participate in the resolution and investigations associated with Non-conformance processes (OOS, OOT, CAPA, and deviations).
- Stocking of laboratory supplies, as needed.Assist in cleaning of laboratory and other spaces.
- Assist the Operations group with technical/operational support, as needed.
- Bachelor’s degree or equivalent experience in a related life science discipline or other relevant degree.
- 1+ years of Quality Control experience in a cGMP laboratory setting.
- Familiar with 21 CFR 58, 210, 211, 600 and 1271.
- Excellent verbal and written communication skills.
- Capable of working as an individual or in a team setting.Motivated self-starter capable of operating in a start-up environment.
Job Category: Faculty
Primary Location: Aurora
Posting Date: Feb 19, 2021
Unposting Date: Ongoing