Quality Control Analyst I – Data ReviewerTechnical Writer

University of Colorado Anschutz Medical Campus

Department:Gates Biomanufacturing Facility

Job Title: Quality Control Analyst I Data Reviewer/Technical Writer

Position #: 803791 Requisition #:37813

Job Summary:

This position is a full-time senior-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Control team. This position will be responsible for performing data review for cGMP Quality Control (QC) documentation as well as some development and non-GMP documentation at the Gates Biomanufacturing Facility (GBF). This position will also involve interacting with project management and interfacing with clients. Routine work will also include drafting and reviewing quality events to support batch release for Phase I cell therapy and biotherapeutic products manufactured at GBF. This position requires industrial experience related to performing and reviewing analytical testing in a cGMP Quality Control setting. Extensive experience with deviations and CAPAs in a cGMP setting is also required.

The Gates Biomanufacturing Facility is an academic cGMP contract manufacturing facility dedicated to the development and manufacture of novel biologics and cell therapies for early phase human clinical trials. 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.

Key Responsibilities:

• Perform a complete data review for all QC cGMP documentation to support batch release

• Perform a complete data review for all cGMP Environmental Monitoring (EM) testing EM reports EM excursion events and growth promotion data

• Perform a complete data review for QC method development and non-GMP experiments including the review of QC notebooks

• Drafting and updating documentation related to the data review process in conjunction with QA.

• Track collate draft and review cGMP QC quality events including deviations CAPAs EM excursions Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations

• Review in-use and completed QC log books

• Oversee the continuous monitoring program and address warnings and excursions related to cGMP QC instrumentation including drafting Non-Conformance (NC) investigations

• Work closely with QC analysts scientists and supervisors to translate complex technical processes into clear user-friendly documentation.

• Ensure all QC documentation meets Good Manufacturing Practice (GMP) Good Documentation Practice (GDP) and other applicable regulatory requirements.

• Support technology transfer method qualification/validation and implementation of new instruments or systems by preparing appropriate documentation.

• Draft edit and maintain QC-related standard operating procedures (SOPs) test methods work instructions protocols and reports.

• Standardize document templates and promote best practices in scientific and technical writing.

Work Location:

Onsite this role is expected to work onsite and is located in Aurora CO.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40000 employees strong with the family atmosphere of working with a team of 50 highly dedicated people operating on a top tier research campus the University of Colorado Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

In addition to the benefits offered a few links are included below identifying some of the exciting life sciences the Gates Institute is delivering to patients.

Why work for the University

We haveAMAZINGbenefits and offerexceptional amounts of holiday vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability Life Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year

• Vacation Days: 22/year (maximum accrual 352 hours)

• Sick Days: 15/year (unlimited maximum accrual)

• Holiday Days: 10/year

• Tuition Benefit: Employees have access to this benefit on all CU campuses

• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

• Bachelors in molecular biology biochemistry chemistry immunology or related life science degree. Substitution: A Masters degree in a related life science degree or related technical/paraprofessional experience may be substituted for the bachelors degree on a year-for-year basis.

• 2 years of experience operating in a cGMP Quality Control laboratory with specific experience drafting quality events such as deviations Out Of Specification (OOS) CAPAs and change controls.

Applicants must meet minimum qualifications at the time of hire.

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:

• 3 years of cGMP Quality control experience

• Experience with working in a biotech growth/startup environment is preferred.

• Experience performing various QC analytical methods. Flow cytometry HPLC UV-Vis DLS qRT-PCR ELISA cell-based assays cell viability assays and fluorescence microscopy.

Competencies/Knowledge Skills & Abilities:

• 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.

• Strong understanding of GMP GDP and regulatory compliance requirements

• Broad experience with analytical methodologies such as Flow Cytometry HPLC/UPLC UV-Vis DLS qPCR ELISA Cell-based assays Cell Viability assays Fluorescence Microscopy Bioburden Endotoxin Gram Stain and Mycoplasma

• Broad experience with cGMP quality events (Deviations CAPAs NCs OOS etc.)

• Experience working in a start-up environment with a track record of being a team-oriented self-starter capable of operating independently

• Excellent written communication skills with ability to translate scientific concepts into clear instructions.

• Effective interpersonal communication skills both written and verbally

• Strong technical writing skills

How to Apply:

For full consideration please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references including name address phone number (mobile number if appropriate) and email address

Questions should be directed to: Chandresh Undhad

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration apply by October 8 2025.

Anticipated Pay Range:

The starting salary range for this position has been established as $59701- $75940.

The above salary range represents the Universitys good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

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.

Total Compensation Calculator:

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal state and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity and we encourage individuals from all backgrounds to apply including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act please contact the Human Resources ADA Coordinator at .

Background Check Statement:

The University of Colorado Anschutz Medical Campus 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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and othervaccine preventable diseases. If you work visit or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work visit or volunteer addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.