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University of Colorado PRA - QA Associate/Engineer in Aurora, Colorado

University of Colorado – School of Medicine

PRA - QA Associate/Engineer

The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

GatesBiomanufacturing Facility (GBF)located on the University of Colorado – Anschutz Medical Campus isseeking a Quality Assurance Associate/Engineerfor our Good Manufacturing Practice (GMP) cell therapy and biologics production and testing facility.As a part of the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology,GBF serves as a development and manufacturing organization for the University of Colorado, UCHealth and Children’s Hospital of Colorado as well as industry based partners.The Gates Biomanufacturing Facility is dedicated to the development and manufacture of novel biological and cell/gene therapies to support early phase human clinical trials. This highly visible position will be responsible for ensuring all GMP manufacturing and testing activities are in compliance with the GBF Quality Management System (QMS).

In this fast-paced environment, Quality Assurance Associates/Engineers work collectively to provide continuous oversight of all GMP operations encompassing materials, manufacturing, testing, and facility operations. This position will also be responsible for assisting with the administration and continuous improvement of the QMS. These responsibilities require a high degree of accuracy and attention to detail. The ability to work well independently as well as in a team environment is crucial as the position reports to Quality Assurance (Manager/Director), and communicates regularly with all levels of personnel within the GBF, University, external vendors and clients.

Job Responsibilities

  • Provide GMP support for the contract manufacture of protein biologics and cell/gene therapies to enable and support early-phase (i.e. Phase 1) clinical trials.

  • Drive continuous improvement to key quality operational procedures and systems.

  • Review/approve key manufacturing, testing, equipment, utilities, facilities documentation including batch records, deviations/investigations, test data, and qualification protocols and reports.

  • Provide Quality input and approval on deviations, investigations, environmental monitoring excursions, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA) and change controls.

  • Assist to establish specifications for equipment, processes, raw materials and final product in conjunction with Subject Matter Experts.

  • Provide documents/labels to Operations for product runs; assist in all aspects of document control.

  • Assist in performing audits of the facility and follow up on reconciliation of any findings via formal reports and responses.

  • Resolve vendor issues including aspects of supplier corrective action procedures.

  • Support materials management including release/quarantine of materials and investigation into non-conforming materials.

  • Assist in the administration of the GBF site-wide training program.

  • The position will require occasional evening/weekend work to accommodate operational activities that may occur outside of normal business hours. While not typical, this irregularity of work hours should be expected. Minimal travel is expected..

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 atEmployee 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 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.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits:https://www.cu.edu/employee-services/benefits.

Total Compensation Calculator:https://www.cu.edu/employee-services/total-compensation

Diversity and Equity:

Please click here for information on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx

The University of Colorado Denver | Anschutz Medical Campus 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. 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.

Professional Experience

  • B.S. in an Engineering/Biological Sciences discipline or equivalent; M.S. preferred, but not required.

  • Minimum of 3-5 years of experience in a Quality Assurance operational role, mainly in the production oversight of pharmaceuticals, biologics and/or cell/gene therapies.

  • Familiarity with manufacturing operations in regards to compliance with 21 CFR 210, 211, 600, 1271, and/or FACT regulations.

  • Demonstrated ability to operate and manage an electronic quality management system.

  • Experience with aseptic techniques, gowning practices and general operations within an ISO-controlled, clean room environment.

  • Comprehensive understanding of risk management and root cause analysis tools (e.g. FMEA, Ishikawa, Fishbone, etc.). Operational experience leading materials non-conformances, deviations, investigations, out of specification results, and corrective/preventive actions.

  • Experience working in a Just in Time (JIT) environment relating to manufacturing, material procurement, kitting, release and distribution of finished product; preferred but not required.

Soft Skills

  • Ability to work in a fast paced, highly collaborative environment with a demonstrated commitment to develop long-term relationships with colleagues, clients, and community is required.

  • Must be a goal-oriented, self-starter capable of operating both independently and as a part of a team in a start-up environment.

  • Detail oriented with good organizational, communication and time management skills.

  • Able to identify, communicate, report and correct quality concerns effectively and efficiently.

  • Good oral and written communication skills across all levels of internal personnel, University staff, vendors or clients.

Technical Skills

  • Experience in the Microsoft Office suite including MS Word, Excel and Outlook.

  • Administration and routine use of electronic document management systems (e.g. Documentum, etc.), strongly preferred.

  • Operational use of electronic resource planning (MRP/ERP) and/or inventory management systems, highly desirable.

Working Environment/Physical Demands

/Physical Demands/

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Job also includes repetitive motions; movements frequently and regularly required using the wrists, hands, and/or fingers; average visual acuity necessary to prepare or inspect documents or products. Position requires sitting and standing most of the time with occasional bending, stooping, and lifting.//

Job: *Faculty

Organization: *H0001 -- Anschutz Medical Campus

Title: PRA - QA Associate/Engineer

Location: Aurora

Requisition ID: 15508

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.

Click here for a list of ADA and Title IX coordinators. To view the Regent policy, please click here.

This organization participates in E-Verify. We will provide the Social Security Administration and, if necessary, the Department of Homeland Security, with information from each employee's I-9 form to confirm work authorization.

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