PRA - Environmental Technician
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 implementation and administration of key aspects of the Quality Management System at the Gates Biomanufacturing Facility.
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 Engineer 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.
- 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 validation of processes which cross shifts. While not typical, this irregularity of work hours should be expected.
- Report to the Manager of Quality Control as well as the Director of Quality Assurance
- Work in a multidisciplinary, multi-accreditation, and regulatory space for protein biologics and regenerative medicine therapies.
- Implementation and operation of a quality/cGMP based program for the contract manufacturing of protein biologics and regenerative medicine therapies for phase 1 and 2 clinical trials.
- Execute key quality operational SOPs at the new facility.
- Administer the GBF environmental monitoring program through procedural execution.
- Resolve technical issues regarding equipment used.
- Walk-through of facility for environmental issues.
- Act as contact for process monitoring
- Participate in site training program.
- Compile information and results into meaningful formats to ensure content is appropriately represented.
- Inspect packaged materials in accord with site requirements, procedures and specifications.
- Compile QMS analysis data through statistical trending and reporting of key performance indicators (KPI).
- Assist in cleaning of cGMP spaces.
- Provide exceptional customer service to users of the facility.
- Work in a professional and collaborative manner with coworkers and prospective users.
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.
The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.
- A minimum of 1 year of experience in a microbiology.
- Bachelor's Degree or equivalent experience in a biology, microbiology, biochemistry discipline or equivalent.
- Excellent communication skills in both written as well as presentation of data.
- Experience working and familiar with gowning practices for a clean room environment.
- A team-oriented, self-starter capable of operating independently in a start-up environment.
- A minimum of 1 year of experience in a pharmaceutical microbiological environment.
- Experience and understanding of aseptic technique and environmental monitoring.
- Experience with GLP microbiology practices.
- Experience working with multiple client driven projects.
Special Instructions to Applicants:
Questions should be directed to Gabriel Orosco - firstname.lastname@example.org
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 10881
When applying, applicants must include:
- A letter of application which specifically addresses the job requirements and outlines qualifications
- A current Resume/CV
- 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 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
Posting Date: Aug 30, 2017
Closing Date: Ongoing
Posting Contact Name: Gabriel Orosco
Posting Contact Email: email@example.com
Position Number: 00050220