Quality Assurance Systems Associate II

University of Colorado CU Anschutz Medical Campus

Chancellor’s Office Gates Biomanufacturing Facility

Research Services Senior Professional

Quality Assurance Systems Associate II

Requistion #27804 Position #803749

**Position open to current University of Colorado System employees only**

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.  Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012—covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

• Anschutz Campus – Exemptions are allowed for medical or religious reasons.
• Denver Campus – Exemptions are allowed for medical, religious, or personal reasons.
• Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.

The University of Colorado 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.

Gates Biomanufacturing Facility has an opening for a full-time University Staff (unclassified) Quality Assurance Systems Associate II position.

The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals – UCHealth University of Colorado Hospital  and Children’s Hospital Colorado  – that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu .

Position Emphasis:

This position is a full-time, senior-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Cell Therapy.  This position will be responsible for day-to-day maintenance, updating and expanding use of QMS (Q-Pulse). This position is also accountable for GBF document printing, control, and archiving process. This position will report to the Supervisor of Quality Assurance.

Specific Job Responsibilities:

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

• Provide Quality Assurance support for the contract manufacture of protein biologics and cell/gene therapies to enable and support early-phase (i.e. Phase 1) clinical trials.
• Act as an admin, attend training sessions to develop advanced skills for QMS system maintenance, development, and implementation.
• Day-to-day maintenance of QMS system including but not limited to new client code generation, document number generation, training event creation and user interface for various QMS modules
• Participate in planning of onboarding additional Quality modules, provide cost analysis and detailed data driven justification to support the case.
• Attend training sessions and acquire skills to become primary person responsible for creating electronic forms and reports in QMS system.
• Primary person responsible for scheduling and providing QMS hands on training to current and new employees.
• Responsible for processing security access request for GBF staff and contactors
• Manage document workflows in GBF electronic document management system ensuring documents go through controlled document life cycle in accordance established procedures.
• Ensure documents meet formatting and template requirements, adhere to required review and approval requirements and project timelines.
• Accountable for GMP documentation printing, tracking, scanning, reconciliation, and archiving
• Accountable for file room inventory, filing, and scanning. Manage offsite document archival with approved vendors
• Provide input for capabilities and user needs for QMS system
• Assist in performing audits of the facility and follow up on reconciliation of any findings via formal reports and responses.
• Author controlled documents and support development of QMS and Document control related procedure and policies
• Participate in batch record review, logbook review and calibration document review as requested.
• Participate in other QA activities as requested.

​​​​​​Salary and Benefits:

The salary range (or hiring range ) for this position has been established at $50,000- $65,000 per fiscal year.  

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

Minimum Qualifications: 

• Education: A bachelor’s degree in a Biological Sciences discipline, Engineering, or a related field.
• Experience: 2+ years of experience in Biopharmaceutical or similar controlled environment. Significant experience in working with QMS system and
• Equivalent combination of education and experience may be substituted.

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

Condition of Employment:

This 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. 

Preferred Qualifications:

• A master’s degree in Engineering, Biological Sciences, or a related field.
• Prior experience with onboarding, managing and developing Quality management System
• Experience working in a Just in Time (JIT) environment relating to manufacturing, material procurement, kitting, release and distribution of finished product.

Competencies:

• Familiarity with Good Manufacturing Practices (GMPs), Good Documentation Practice, Quality management System and Document control
• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.

Additional Competencies:

• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment.

To apply, please visit: http://www.cu.edu/cu-careers and attach:
1. A letter of application which specifically addresses the job requirements and outlines qualifications
2. A current CV/resume
3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)

Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Application deadline is October 16th, 2022.