Senior Professional Research Assistant - Quality Control Manager
University of Colorado - School of Medicine
Senior Professional Research Assistant
The 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 management of the Quality Control Laboratory 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.
This role will have the following responsibilities including but not limited to the following:
- Analytical testing
- Flow Cytometery
- Real-time PCR
- Cell based ELISA
- HPLC/UV Spec
- SDS Page
- Western Blot
- Qualification and/or verification of analytical methods
- Environmental monitoring program
- Sterility and bioburden testing
- Cleaning program
- Manage a Quality Control Laboratory with state of the art analytical instruments for cGMP protein biologics and regenerative medicine products for phase 1 and 2 clinical trials.
- Supervise multiple laboratory technicians including the review of the quality of work.
- 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 including the quality control review of critical documents (i.e. Batch Records), specifications, procedures and other technical documents.
- Analyze the performance and health of the lab compliance via reports, managing issues to resolution and in conformance with quality metrics and compliance requirements.
- Participate in the compliance of laboratory vendors with regards to the GBF supplier quality assurance program.
- Responsible for calibration and maintenance for laboratory instruments and equipment.
- Review service contracts for laboratory related cGMP services
- Manage traceability and status requirements of in process quality control work orders with site QMS requirements.
- Maintain chain of custody for finished product inventory in the labs charge.
- Participate in the resolution and investigations associated with Non-Conformance Processes (NCR, OOS, OOT, CAPA, and deviations).
- Manage lab employee compliance to site training program.
- Review laboratory and other statistical techniques including 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.
- Manage cGMP/GLP program to meet key performance indicators (KPI) to 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.
- Master's Degree or equivalent experience in a life science discipline or relevant degree, as designated by the Dean or Dean's designee.
- A minimum of 2 years of Quality Control experience in direct laboratory management.
- Working knowledge of 21 CFR 58
- Working knowledge of 21 CFR 210, 211, and 600.
- Excellent communication skills in both written as well as presentation of data.
- Experience in analytical method development, qualification, or validation experience
- 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.
- Complete understanding of investigation methods, documentation of, and appropriate quality disposition of conformance issues.
- A minimum of 5 years of Quality Control experience in direct laboratory management.
- Deep knowledge of 21 CFR 210, 211, and 600.
- Hands on experience administering quality control and/or GLP requirements.
- Experience working with multiple client driven projects.
- Experience with automated quality management systems.
- Experience with LIMS type systems.
- Experience with environmental monitoring database.
- Experience working within a quality management system.
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.
Special Instructions to Applicants:If you are unable to upload the required documents, please contact Julie Clarke at 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: 4915
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: Apr 26, 2016
Closing Date: Ongoing
Posting Contact Name: Julie Clarke
Posting Contact Email: email@example.com
Position Number: 00722939