Advanced Quality Assurance Specialist

**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.** Pay Range: $55,600.00 - $91,450.00 **Position Summary:** The Advanced Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team working to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards. **Key Responsibilities:** * Provides support ensuring compliance with all regulatory standards, systems, procedures, and practices.  Includes ISO 13485, FDA QSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities: * Provide QA support to project core teams. * Provide support to or ownership of key quality management system processes. * Conducts internal and external audits, summarizing the results and providing summaries to Quality Management. * Assists in the management of Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management systems. May be responsible for the management of one or more of these systems. * Reviews and approves validation activities. * Reviews and approves quality equipment calibrations and maintenance. * Supports regulatory and client audits. * Supports the overall QA Department goals. * Generates metrics in support of Quality Management Reviews. * Other duties as assigned. **Education and Experience:** * Bachelors/Masters degree in a related field from an accredited four-year college or university, 4-6 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience. **Knowledge, Skills, and Abilities:** * Skilled in the use of software programs such as Microsoft Office and database management programs. * Detail oriented and skilled at examining documents for accuracy and completeness.  Ability to prepare records in accordance with detailed instructions. * Knowledgeable in QA principles and concepts in a dynamic manufacturing facility * Ability to set priorities and meet deadlines on a personal level.  Ability to work under tight deadlines. * Capability to effectively train employees on procedures, processes, and QA concepts. * Team oriented individual with the ability to work effectively with multiple skill level employees.  Skilled at dispute resolution. * Excellent written and oral communication skills. * Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision.  * Familiarity with statistical tools and concepts and their application in a regulated environment. * Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR preferred. **Why Join Bio-Techne:** * ### We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. * ### We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA. * ### We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more. * ### We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.  * ### We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave. * ### 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.** **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.** _**This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact**_ [_**[email protected]**_](mailto:[email protected]) _**for assistance.**_