Quality Control Manager
Company: University of Colorado Anschutz Medical Campus
Location: Aurora
Posted on: October 23, 2024
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Job Description:
University Staff Description University of Colorado Anschutz
Medical Campus
Department: Gates Biomanufacturing Facility
Job Title: Quality Control Manager
Position #:00828303 - Requisition #:35274
Job Summary:
The Quality Control Manager will be responsible for managing all
aspects of the Gates Biomanufacturing Facility (GBF)
multi-disciplinary Quality Control laboratory, including day-to-day
oversight of Microbiology and analytical testing operations, and
the management of up to ten reports. This role is responsible for
the development and optimization of systems specific to or that
intersect with the Quality Control laboratory, scheduling all
analytical work, and routinely interacting with clients. This
position will actively support the development and implementation
of QC strategic goals and initiatives and serve as a QC main point
of contact.
Key Responsibilities:
Manage up to ten Quality Control reports which may include
supervisors, analysts, data reviewers, and associates.
Schedule all laboratory activities including batch testing,
environmental monitoring, stability studies, and analytical
development work.
Oversee all Quality Control document drafting including analytical
procedures, general SOPs, qualifications protocols, stability
protocols, summary reports and other protocol that requires
analytical support.
Direct interaction with internal (CU) and external clients
regarding project scope, project timeline, method transfer, method
development, troubleshooting, establishment of release criteria,
and stability programs.
Coordinate manufacturing campaigns, studies, timelines, and
deliverables with other Department Leads and Quality Control
reports.
Manage the completion of all Quality Control quality events
including CAPAs, Deviations, Out of Specifications (OOS), and
Change Controls.
Ensure that Quality Control personnel are compliant with the site
quality program.
Work Location:
Onsite - this role is expected to work onsite and is located in
Aurora , Colorado.
Why Join Us:
The opportunity offered by the Gates Institute is one of a kind.
They blend the best of a large research organization of over 40,000
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. They are only limited by their resources and need
you to make their 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.
CU's Benefits:
The University of Colorado offers a comprehensive benefits package
that includes health insurance, life insurance, retirement plans,
tuition benefits, ECO pass, paid time off - vacation, sick, and
holidays and more. To see what benefits are available, please
visit: .
Why work for the University?
We have AMAZING benefits and offer exceptional 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 .
Diversity and Equity:
The University of Colorado 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, ethnically minoritized
individuals, persons with disabilities, persons within the LGBTQ+
community and all veterans. In addition, the Anschutz Campus has
also been recognized as an Age-Friendly University. The University
of Colorado is committed to diversity and equality in education and
employment.
Qualifications:
Minimum Qualifications:
Bachelor's degree in Chemistry, Biology, Biochemistry, Immunology,
or related field.
Substitution: A combination of education and related
technical/paraprofessional experience may be substituted for the
bachelor's degree on a year-for-year basis.
10 years of laboratory experience across multiple analytical
disciplines.
7 years of operational experience in a cGMP quality position
(Quality Control or Quality Assurance).
2+ years of experience in personnel management.
Industrial experience, which included testing and release of cell
therapy and protein biologics in a cGMP Quality Control
setting.
Applicants must meet minimum qualifications at the time of
hire.
Preferred Qualifications:
Master's degree in Chemistry, Biology, Biochemistry, Immunology, or
related field.
10 years of operation experience in a cGMP Quality Control
position.
5+ years of experience with analytical method development,
qualification, and validation.
Experience with 21 CFR Part 11.
Experience working in a biotech startup environment.
Competencies: Knowledge, Skills, and Abilities:
A deep understanding of cGMP regulations (21 CFR 210/211, 600,
1271), FDA Phase I guidance, as well as other industry guidance
(ICH, ISO, USP, etc.).
Extensive experience with the Microsoft Office Suite (Word, Excel,
PowerPoint, Teams).
Strong technical writing skills.
Strong written and verbal communication skills.
Team-oriented, self-stater capable of operating independently.
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.
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: Donna.3.Parker@cuanschutz.edu
Screening of Applications Begins:
Immediately and continues until October 27th, 2024.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has
been established as $97,481 - $123,996.
The above salary range (or hiring range) represents the
University's good faith and reasonable estimate of the range of
possible compensation at the time of posting. This position may be
eligible for overtime compensation, depending on the level.
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:
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 other . 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,
respectively. In addition, if you work in certain research areas or
perform certain safety sensitive job duties, you must enroll in the
.
Application Materials Required: Cover Letter, Resume/CV, List of
References Job Category: Research Services Primary Location: Aurora
Department: U0001 -- Anschutz Med Campus or Denver - 21796 - ADM
CHAN GBF Spnsrd/Gift Schedule: Full-time Posting Date: Oct 22, 2024
Unposting Date: Oct 28, 2024, 5:59:00 AM Posting Contact Name:
Donna Parker Posting Contact Email: Donna.3.Parker@cuanschutz.edu
Position Number: 00828303
Keywords: University of Colorado Anschutz Medical Campus, Denver , Quality Control Manager, Executive , Aurora, Colorado
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