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## Advanced Quality Assurance SpecialistApplyremote type: In-personlocations: Austin, TXtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR102029**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*** ***hr@bio-techne.com*** ***for assistance.*** #J-18808-Ljbffr