Quality Control Manager

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

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 CU Advantage .

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) :

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

Curriculum vitae / Resume

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

Questions should be directed to : [email protected]

Screening of Applications Begins :

Immediately and continues until October 27

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 : http : / / www.cu.edu / node / 153125

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 hr.

[email protected] .

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 vaccine 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, respectively.

In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program .

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 : [email protected]

Position Number : 00828303