PRA - QC Analyst

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 Quality Control testing at the Gates Biomanufacturing Facility and will be focused on protein analytical testing.

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.

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).

• 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.

• Report to the Manager of Quality Control

• Perform analytical testing in a multidisciplinary, multi-accreditation laboratory space in support of analytical development, qualification and release testing of protein biologics and regenerative medicine therapies.

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

o Analytical testing

o HPLC/UV Spec

o SDS Page

o Western Blot


o Qualification and/or verification of analytical methods

o Buffer preparation

o Assist in process development work as needed.

• Operate and maintain state of the art analytical instruments for cGMP protein biologics and regenerative medicine products for phase 1 and 2 clinical trials.

• Stocking of laboratory supplies, as needed.

• Ensure all work is in accordance with site procedures, specifications and training to maintain the highest level of quality.

Develop and implement key laboratory and analytical SOPs at the new facility.

Develop, execute, and review results from key analytical methods, laboratory equipment and process validation protocols at the new facility.

• Use an electronic document control system to obtain documents (i.e. Batch Records), specifications, procedures and other technical documents.

• Ensure all laboratory instruments and equipment are within calibration and maintenance requirements prior to use.

• Ensure traceability and status requirements of in process quality control work orders with site QMS requirements.

• Ensure chain of custody for work in the labs charge.

• Participate in the resolution and investigations associated with Non-Conformance Processes (NCR, OOS, OOT, CAPA, and deviations).

• Ensure personal compliance to site training program.

• Execute experiments/studies in accord with protocols, procedures, statistical techniques, and developed DOEs.

• Participate in the risk management program including identification and mitigation of new process risks regarding QC Testing or other experimental techniques.

• Compile information and results into meaningful formats to ensure content is appropriately represented.

• Ensure work comports the cGMP/GLP program to meet key performance indicators (KPI) to meet quality objectives.

• Assist in cleaning of laboratory and other spaces.

• Provide exceptional customer service to users of the facility.

• Work in a professional and collaborative manner with coworkers and prospective users.

• As needed, assist development scientists and operations with technical/operational support.

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.


Required Qualifications:

• A minimum of 1 year of Quality Control experience in a laboratory setting.

• Bachelors Degree or equivalent experience in a related life science discipline or other relevant degree.

• Familiar with 21 CFR 58,

• 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.

Preferred Qualifications:

• A minimum of 3 years of Quality Control experience in a clinical laboratory setting.

A Medical Technologist with an analytical testing focus.

Familiar with 21 CFR 210, 211, and 600.

• Experience in protein biologics development and/or release testing.

• Experience in Analytical method development, qualification, or validation experience

• Hands on experience on a production floor administering quality management system requirements.

• Experience working with multiple client driven projects.

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

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 11465

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 two 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: Oct 13, 2017

Closing Date: Ongoing

Posting Contact Name: Carmen Garcia

Posting Contact Email: [email protected]

Position Number: 00050377





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Job No:
Posted: 2/28/2018
Application Due: 4/11/2018
Work Type: