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Quality Assurance Analyst

Bio-Techne
Wallingford, CT Full Time
POSTED ON 1/11/2025
AVAILABLE BEFORE 4/10/2025

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.Position Summary : Reporting to the Quality Supervisor, this position is responsible for planning, executing, and managing activities in the Simple Plex cartridges QC process to ensure that all applicable objectives are met, and the product functions as expected. To be successful in this role candidate needs to be skilled in analytical techniques for analysis of biological assays. This position interfaces with Manufacturing, Process Engineering, Product Support, Assay Development and Quality Assurance.Key Responsibilities : Compile, document, interpret and manage biological data to evaluate the quality of in-process materials and finished goods to either confirm compliance with established quality standards or identify deviations. This includes functional, assay performance, precision, and accuracy testing. Data management comprises analysis and disposition of data produced and curation of that data into a LIMS database.Ensure that the final product satisfies the product requirements and meet end-user expectationsSupport deviation and out-of-specification investigationsProvide recommendations for corrective actionsSpot areas for improvement to enhance the product's efficiencyMaintain clear and accurate recordsAttend cross-functional team meeting and present data summariesPerform lab work when needed, including preparation of controls and reagents, and performing instrument runsSupport new product launch activitiesMay be responsible for establishing specifications and writing standard operating proceduresSupport other QC operations, like Simple Plex consumables, as neededEducation and Experience : Bachelor’s degree in biology, Chemistry or Engineering with 2 years’ experience.Non- scientific bachelor’s degree with 4 years’ experience working in a quality position for a GMP or life science related industry.Knowledge, Skills and Abilities : Outstanding analytical skills. R Analysis experience a plus.Super user level in Excel and proficient in all Microsoft Windows functionsAbility to evaluate large volumes of data in a short timeframeStrong understanding of quality system regulations and standardsExperience working within an ISO compliant, or other regulated environment.Experience developing, reviewing, deploying Standard Work (WI’s, MI’s, SOPs)Strong presentation skillsExperience with immunoassay methodology a plusDemonstrated ability to deliver quality work, with high work accuracy.Demonstrated ability to meet project timelines and collaborate with internal teamOrganized with exquisite attention to detailWhy Join Bio-Techne : We offer competitive wages along with extensive benefits for employees and their families.We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.Bio-Techne is an E-Verify Employer in the United States.Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.Pay Range : $52,000.00-$85,600.00Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services.Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.

Salary : $52,000 - $85,600

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