Quality Assurance Analyst

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 expectations Support deviation and out-of-specification investigations Provide recommendations for corrective actions Spot areas for improvement to enhance the product's efficiency Maintain clear and accurate records Attend cross-functional team meeting and present data summaries Perform lab work when needed, including preparation of controls and reagents, and performing instrument runs Support new product launch activities May be responsible for establishing specifications and writing standard operating procedures Support other QC operations, like Simple Plex consumables, as needed Education 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 functions Ability to evaluate large volumes of data in a short timeframe Strong understanding of quality system regulations and standards Experience working within an ISO compliant, or other regulated environment. Experience developing, reviewing, deploying Standard Work (WI's, MI's, SOPs) Strong presentation skills Experience with immunoassay methodology a plus Demonstrated ability to deliver quality work, with high work accuracy. Demonstrated ability to meet project timelines and collaborate with internal team Organized with exquisite attention to detail Why 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. Bio-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.

Created: 2024-10-30