Posting Details
Posting Detail Information
Working Title
PSRL & OBRL Quality Assurance Specialist I
Position Location
Fort Collins, CO
Work Location
Position is fully in-office/in-person
Research Professional Position
No
Posting Number
202500288AP
Position Type
Admin Professional/ Research Professional
Classification Title
Prof/Indiv Contrib I
Number of Vacancies
Work Hours/Week
40
Proposed Annual Salary Range
$60,000-$80,000
Employee Benefits
Colorado State University is not just a workplace; it's a thriving community that's transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact.

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Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by 11:59pm (MT) on
03/17/2025
Description of Work Unit
The Department of Clinical Sciences mission is to assure the health and productivity of animals to meet societal needs through high quality educational programs for professional veterinary medical students, graduate veterinarians, and the public through a faculty and veterinary medical center of excellence, and to advance and disseminate comparative biomedical knowledge in an environment of interdisciplinary collaboration.
Position Summary
The Preclinical Surgical Research Laboratory (PSRL) and Orthopedic Bioengineering Research Laboratory (OBRL) are seeking a Quality Assurance (QA) Specialist I to support the CSU Quality Assurance Program and assure, under the direction of the QA Manager, that CSU is in full compliance with institutional and federal Good Laboratory Practice (GLP) policies and regulations, on behalf of the Institutional Official (the Vice President for Research) and the Provost. The QA Specialist I maintains systems and infrastructure required for compliance with GLP activities.
This position is a full-time appointment, based on the CSU Fort Collins campus.
The successful candidate must be legally authorized to work in the United States by the proposed start date. The department will not provide visa sponsorship for this position.
Required Job Qualifications

• Bachelor's degree with a minimum of 2 years of experience in QA or Compliance experience supporting GLP operations in biologics, pharmaceutical, and/or medical device industry or an equivalent combination of education and experience.

Or

• Associate degree with a minimum of 4 years of experience in QA or Compliance experience supporting GLP operations in biologics, pharmaceutical, and/or medical device industry or an equivalent combination of education and experience.

PLUS

• Experience with audits; conducting process improvements; addressing OECD, ISO, or other standards; and interacting with regulatory agencies.
• Experience collaborating with a QA team.
• The successful candidate must be legally authorized to work in the United States.

Preferred Job Qualifications

• RQAP or equivalent professional certification.
• Experience interacting with FDA and other US regulatory agencies.
• Experience managing FDA and other US regulatory agencies' audits.
• Experience with GLP QA operations Experience in academic and industry settings.

Essential Duties
Job Duty Category
Quality Assurance Inspection Services
Duty/Responsibility

• Review documentation in support of process validation and product review at all stages of regulated research activity
• Under the direction of the Quality Assurance Manager, lead internal audit activities to ensure that regulated research activities are conducted in accordance with sponsor protocols, GLP, industry guidelines, and regulatory agency standards
• Under the direction of the Quality Assurance Manager, lead audits of external vendors and sites
• Review vendor supplied data and quality records for conformance and good documentation practices (GDP)
• Monitor and track the review cycle of policies and procedures relevant to GLP activities

Percentage Of Time
75
Job Duty Category
Quality Assurance Oversight
Duty/Responsibility

• Perform continuous improvement of PSRL and OBRL quality systems under the direction of the Quality Assurance Manager
• Ensure GLP compliant procedures and processes are in place to support regulated activities conducted at PSRL and OBRL
• Actively lead and/or assist activities in the areas of internal quality audits, Corrective and Preventive Actions (CAPAs), and quality management reviews
• Ensure adherence to all sponsor quality policies and procedures as stated in the Quality Manuals
• Supervise, lead, or assist with activities related to any external sponsor and regulatory agency audits of PSRL or OBRL regulated research activities
• Under the direction of the Quality Assurance Manager, lead review of monitoring reports and track CAPAs to completion, escalating important events to senior management Provide training to research and manufacturing staff as needed and document training Support projects requiring QA input
• Perform other related duties as assigned

Percentage Of Time
25
Job Duty Category
Ongoing Professional Development and Contribution
Duty/Responsibility

• Collaborate with CSU IRB, IACUC and IBC coordinators on GLP and related regulatory (e.g. IND/INAD) issues
• Participate in Conferences, training, and other related programs that support CSU research quality
• Support the development of CSU, PSRL, and OBRL policies and procedures for regulated research issues
• Act as a PSRL and OBRL key representative in CSU QA leadership activities

Percentage Of Time
5
Application Details
Special Instructions to Applicants
This position will remain open until filled. To apply, please upload a cover letter that addresses the required and preferred job qualifications, a resume, and the contact information for three professional references.
CSU is committed to full inclusion of qualified individuals. If you are needing assistance or accommodations with the search process, please reach out to the listed search contact.
References will not be contacted without prior notification to candidates. Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.
Conditions of Employment
Pre-employment Criminal Background Check (required for new hires)
Search Contact
EEO
Colorado State University (CSU) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Background Check Policy Statement
Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.