Sr PRA - Quality Engineer
University of Colorado - School of Medicine
Senior 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 Assurance 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.
- Develop and implement key quality operational SOPs at the new facility.
- Develop and execute key equipment, utilities, facilities and process validation protocols at the new facility.
- Establish specifications for equipment, processes, ingredients and raw materials in conjunction with Subject Matter Experts.
- Choose appropriate vendors to fulfill established specifications.
- Gather data and communicate reports on a periodic and on-demand basis for quality management system status.
- Administer the GBF supplier quality assurance program.
- Resolve technical issues regarding asset system for calibration and maintenance.
- Administer service contracts for cGMP services including maintenance and calibration including scheduling of services in accord with ongoing project and forecasts.
- Resolve vendor issues including any aspects of supplier corrective action procedures.
- Ensure materials are in accord with traceability and status requirements and segregate as needed.
- Review finished product status through cryogenic inventory software.
- Document Review (Batch Records, analytical methods, memo's, etc.)
- Document Management - Provide documents/labels to Project Managers for process/product runs
- Walk-through audits of facility, reconciliation for findings of walk-through
- Act as contact for process monitoring
- Manage quarantine of materials programs in conjunction with Non-Conformance Processes
- Manage the day to day status of segregation, quarantine and recall of calibrated items including Lock Out Tag Out (LOTO) and signage of instruments and equipment.
- Release labels for finished product and secondary packaging.
- Ensure contractor and service personnel are trained to site requirements.
- Administer 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.
- Responsible for all customer owned property.
- Coordinate shipping of materials to customer sites as defined in the quality management system.
- Present 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 3 years of Quality Engineering experience in a pharmaceutical production environment.
- Master's Degree or equivalent experience in an Engineering discipline or equivalent.
- Familiar with 21 CFR 210, and 211
- Familiarity with successfully implementing a quality management system.
- 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.
- Understanding of risk management and associated risk analysis tools (e.g., FMEA, FTA)
- Hands on experience on a production floor administering quality management system requirements.
- Understanding of Quality Engineering statistical techniques including DOE
- Experience and understanding of aseptic technique and environmental monitoring.
- A minimum of 5 years of Quality Engineering experience in a pharmaceutical production environment.
- Experience with biological drug manufacturing.
- Additional experience in 600, 1271, or FACT.
- Knowledge of HCTP/1271 is a plus but not required for consideration.
- Experience working in a JIT manufacturing setting related to BOM assemblies as well as finished product.
- Experience working with multiple client driven projects.
- Experience with electronic quality management systems
- Complete understanding of investigation methods, documentation of, and appropriate quality disposition of conformance issues. This includes NCR, CAPA, OOS, OOT, Simple Actions as well as deviations.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 10827
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 24, 2017
Closing Date: Ongoing
Posting Contact Name: Carmen Garcia
Posting Contact Email: firstname.lastname@example.org
Position Number: 00050263