Quality Assurance Specialist III

Quality Assurance Specialist III Colorado State University - 4.2 Fort Collins, CO Job Details Full-time $95,000 - $115,000 a year 14 hours ago Qualifications Research laboratory experience GLP Veterinary experience Laboratory experience Clinical laboratory experience Senior level Associate's degree FDA regulations 10 years Full Job Description Position Location Fort Collins, CO Work Location Position is fully in-office/in-person Research Professional Position No Posting Number 202501012AP Position Type Admin Professional/ Research Professional Classification Title Prof/Indiv Contrib II Number of Vacancies Work Hours/Week 40 Proposed Annual Salary Range $95,000 - $115,000 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. Review our detailed benefits information here. Explore the additional perks of working at CSU here . For the total value of CSU benefits in addition to wages, use our compensation calculator . Desired Start Date Position End Date (if temporary) To ensure full consideration, applications must be received by 11:59pm (MT) on 08/11/2025 Description of Work Unit CSU is situated in the city of Fort Collins, a dynamic community with a population of approximately 165,000. Located 65 miles north of Denver at the western edge of the Great Plains and at the base of the foothills of the Rocky Mountains, Fort Collins is a gateway to world-class skiing, hiking, fishing, climbing, and biking. With an average of 300 days of sunshine per year and low humidity, Fort Collins residents enjoy pleasant weather year-round. Fort Collins represents the very best of Colorado with top award rankings from Forbes for Best Place for Business/Careers, Gallup Well Being Index for Healthiest Mid-Size City in America, CBS Money Watch's List of Top 10 Best Places to Retire, and Outside Magazine's Best Towns in America, among others. See here for more info on the area: The Office of the Vice President for Research (OVPR) has overall responsibility for promoting and facilitating the research enterprise at Colorado State University (CSU). The OVPR and its research enable the University, its faculty, staff, and students to be part of a world-class research institution complementing our learning, service, and outreach missions. The OVPR plays a key role in the 21st Century Land-Grant mission of Colorado State University by fostering and supporting the research enterprise, promoting scholarship and artistry, instilling a culture of integrity, inclusion and diversity, and capitalizing on opportunities to address global challenges. CSU is recognized as one of the premier research institutions and routinely ranks in the top of all American Universities in research expenditures. Student enrollment is approximately 34,000, and the University employs more than 7,200 staff including academic faculty, administrative professionals, and classified staff. Position Summary The Preclinical Surgical Research Laboratory (PSRL) and Orthopedic Bioengineering Research Laboratory (OBRL) are seeking a Quality Assurance (QA) Specialist III to support the CSU Quality Assurance Unit (QAU) and assure under the direction of the Assistant Vice President for Research Integrity and Compliance, that activities within the PSRL/OBRL comply with institutional- and federal Good Laboratory Practice (GLP) policies and regulations. The QA Specialist III maintains systems and infrastructure required for compliance with GLP activities at PSRL/OBRL. This position requires familiarity with working in a university environment, strong knowledge of process and analytical development, clinical pharmaceutical and biologic manufacturing, non-clinical laboratory processes, and knowledge of non-GLP and GLP quality requirements for pharmaceuticals, devices, biologics, and other regulated categories. This position ensures coordinating with the QAU manager and Test Facility Managers (TFM) that tasks related to planning, coordination, management, and establishment of processes and procedures to assess and monitor the conduct and quality of GLP activities conducted at CSU are identified and accomplished to meet business needs requirements. The person in this position will focus on continuous improvement projects using approved tools, design control, and validations to ensure efficiency and adherence to federal, state, and local regulations, along with industry guidelines, and applicable CSU policies and procedures. Required Job Qualifications Associate degree 10+ years of QA or Compliance experience supporting GLP operations in biologics, pharmaceutical, and/or medical device industry or an equivalent combination of education and experience Experience with audits; conducting process improvements; addressing OECD, ISO, or other standards; and interacting with regulatory agencies Experience collaborating with a QA team Experience with GLP QA operations Experience in academic and industry settings Experience interacting with FDA and other US regulatory agencies Experience managing FDA and other US regulatory agencies' audits Preferred Job Qualifications RQAP or equivalent professional certification Experience in the field of experimental surgical veterinary medicine 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 Assistant Vice President for Research Integrity and Compliance, 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 Assistant Vice President for Research Integrity and Compliance, 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 60 Job Duty Category Quality Assurance Oversight Duty/Responsibility Perform continuous improvement of PSRL and OBRL quality systems under the direction of the Assistant Vice President for Research Integrity and Compliance 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 Assistant Vice President for Research Integrity and Compliance, 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 35 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 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. References will not be contacted without prior notification to candidates. 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. 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 Sarah Pokoski, 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.