Quality Assurance Associate II or Engineer I

University of Colorado•Aurora, CO

13d•Onsite

About The Position

The Gates Institute at the University of Colorado Anschutz is seeking a full-time Quality Assurance Associate II or Engineer I to join the biomanufacturing facility (GBF) in Aurora, CO. GBF is an academic Phase I cGMP contract manufacturing facility dedicated to the development and manufacture of novel biologics and cell therapies for early-phase clinical trials and serves as a core capability that differentiates the University in both regenerative medicine and traditional biotechnology. Within the Gates Biomanufacturing Facility's dynamic environment, become a contributor to Quality Assurance GMP and non-GMP batch support and release activities. The QA Associate II will support the preparation, review, and release of GMP and non-GMP cell therapy and biologic batches, support scanning and archival of GMP and Non-GMP batches, optimize the eQMS batch release system and surrounding SOPs and paper forms, and monitor metrics to ensure batch disposition compliance. Additionally, this position will support material release, equipment management, site training, and other routine QA activities. In addition to the responsibilities above, a QA Engineer I will be responsible and accountable for Quality Assurance and compliance measures for Cell therapy and protein manufacturing GMP facility, this includes overseeing QA evaluations for complex processes (ex. IND, CMC, SMC, etc.) and driving continuous improvement initiatives for quality system. These GMP investigational therapies are being evaluated in Phase I clinical trials.

Requirements

A bachelor’s degree in a Biological Sciences discipline, Engineering or a related field.
Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis, but not for the specific experience.
2+ years of experience in a GMP Quality Assurance operational role, mainly in the production oversight of pharmaceuticals, biologics and/or cell/gene therapies.
4+ years combined experience in GMP Manufacturing, QA, R&D in pharmaceutical, biologics, device, or analytical testing environment (FDA regulated).
2+ years of experience as part of the GMP Quality Assurance team
Experience at this level can be gained simultaneously.
Applicants for all levels must meet minimum qualifications at the time of hire.
Knowledge of FDA cGMP regulations, FACT standards, and GMP documentation practices.
Ability to communicate effectively, both in writing and orally.
Strong English verbal and written communication skills required.
Ability to accurately read, interpret, and produce technical documentation.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Highly self-motivated and organized, with the ability to work both independently and collaboratively in a fast-paced, team-oriented environment.
Technical writing ability to draft and edit controlled documents such as SOPs, Work Instructions (WIs), and forms.
Applicants must be legally authorized to work in the United States without requiring sponsorship.
We are unable to provide work visa sponsorship and employment authorization for this position now or in the future.

Nice To Haves

A master’s degree in scientific discipline, Biological Sciences, or a related field.
Experience working with Good Manufacturing Practices (GMPs) in regard to manufacturing operations and compliance with 21 CFR 210, 211, 600, 1271, and/or FACT regulations.
1+ year or experience with IND generation and review; specifically, CMC Module 3
5+ years combined experience in GMP Manufacturing, QA, R&D in pharmaceutical, biologics, devices, or analytical testing environment (FDA regulated industry).
Prior experience working with Quality Management System such as Title21, Track wise, Q-Pulse/IQM, or Master control.

Responsibilities

Review Batch Records, In-Process and Release testing data, Chain of Custody forms, Receiving Inspections, Thawing and Infusion documentation related to GMP and Non-GMP batch releases
Review and release incoming materials as well as kitted materials
Support review and release of new equipment including Installation Qualifications (IQ), Operational Qualifications (OQ) and Processing Qualifications (PQ) as well as the review and release of annual preventative maintenance (PM) and calibration activities for existing equipment
Monitor batch disposition compliance, metrics, and effectiveness
Review protocols and reports related to INDs, stability, and other GMP and Non-GMP activities
Support optimization of the eQMS related to core systems (e.g., quality events, change controls, CAPAs, etc.) including drafting and revision of new and existing Policy and SOP documents