PRA - QC Enviro Monitor

Job description

University of Colorado - School of Medicine

Professional Research Assistant

The Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology 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 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 GMP environmental testing at the Gates Biomanufacturing.

The University of Colorado Denver is an urban research university serving more than 28,000 students in metropolitan Denver and online. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer 119 highly rated degree programs through 13 schools and colleges. The University of Colorado Denver currently has over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at our Anschutz Medical Campus, a significant number of undergraduate and graduate degree programs are taught at our comprehensive campus in the heart of downtown Denver. Denver is one of America's most vibrant urban centers and the downtown campus, located just steps from the Denver Center for Performing Arts and the LoDo District, affords our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.

The University of Colorado Denver seeks a Quality Control Environmental Monitoring Technician 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 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 in a multidisciplinary, multi-accreditation laboratory space in support of analytical development, qualification/verification and release testing of protein biologics and regenerative medicine therapies.

o All work will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory or a GMP manifesting core.

o This position may support method development.

o This position will not support any academic research.

• Report to the Manager of Quality Control.

Job Responsibilities:Be specific and cover the main aspects of the job as listed in the job description (or include the entire job description). Be sure to include details about the position such as full or part time, work hours (if applicable), and location (e.g., Anschutz Medical Campus, Denver Campus).

• This role will have the following responsibilities including but not limited to the following:

o Water sampling in a GMP facility (Total Organic Carbon, Conductivity, Bioburden)

o Non-viable air testing

o Viable air testing

o Surface testing

o General analytical testing (UV-Vis, pH, Osmolality, CBC, and Endotoxin)

o Buffer preparation

o Qualification and/or verification of analytical methods

o Assist in process 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.

Salary and Benefits:

Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.

The University of Colorado Denver is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

The University of Colorado strongly supports the principle of diversity. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.


Required Qualifications:

  • A minimum of 1 year experience in a GMP laboratory/facility.
  • Bachelor's Degree or equivalent experience in a related life science discipline or other relevant degree.
  • Familiar with 21 CFR 210/211.
  • 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.

Preferred Qualifications:
  • 3+ years of Quality Control experience in a cGMP laboratory setting.
      • Familiar with 21 CFR 58, 600 and 1271.
  • Experience in cellular therapy development and/or release testing.
  • Experience with analytical method development, qualification, verification or validation.

Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 13573

When applying, applicants must include:
  1. A letter of application which specifically addresses the job requirements and outlines qualifications
  2. A current Resume/CV
  3. The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.

Please do not submit any of your application material (via email) to the job posting contact.

Job Category: Faculty

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20143 - SOM-Dermatology

Schedule: Full-time

Posting Date: May 10, 2018

Closing Date: Ongoing

Posting Contact Name: Kia Silverman

Posting Contact Email: [email protected]

Position Number: 00652614





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Job No:
Posted: 5/11/2018
Application Due: 7/10/2018
Work Type: