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.
The Senior 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.
What You’ll Do
Manage and conduct potential supplier audits as well as manage site-level internal audit program including planning, executing, and report writing. Support regulatory and client audits to ensure that the site operates in compliance with all applicable regulations, standards, systems, procedures and practices including Quality System, cGMP, GLP, GCP, CLIA, ISO, FDA, ICH, EU and other regulatory standards as applicable.
Assist in the development, continuous improvement, and implementation of Quality Systems and their SOPs as well as participate in core QMS functions such as Change Control, Supplier Management, NCR, Complaints, CAPA, Training Management, and Document Management processes as required.
Represent QA on cross-functional teams to complete projects, provide guidance, address quality issues, implement quality system improvements, and generate metrics in support of Quality Management Reviews.
Supports the overall Quality goals and QA Department goals.
All other duties as assigned
Who You Are & What You Bring
Education and Experience:
Bachelors/Master’s degree in a related field from an accredited four-year college or university and 5+ years’ experience in a regulated manufacturing testing facility; or a combination of educational and applicable work experience.
Knowledge and Skills:
Accredited quality auditor
Direct experience with managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Complaints)
Knowledge of current global regulatory expectations
Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, and internal stakeholders
Ability to set priorities to meet deadlines and multi-task efficiently
Comfortable in a fast-paced environment with changing priorities
Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project and Databases.
Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision
Knowledge of cGMP, GLP, GCP, CLIA, ISO, OSHA, CE, IVD required
Who We Are and What We Offer
Asuragen, a Bio-Techne brand (NASDAQ: TECH), is a molecular diagnostic company located in Austin, Texas. Our best-in-class reagents, instrument, custom manufacturing, and diagnostic tests are used throughout a patient’s lifespan by laboratories worldwide. Our tests screen for common carriers of rare disorders, diagnose the molecular origins of complex genetic diseases, and pinpoint druggable, needle-in-a-haystack mutations that fuel cancers to address unmet clinical needs with cutting-edge science. Our product portfolio is comprised of reagent kits and software that combine novel assay design, proprietary chemistries, bioinformatic and analysis pipelines to generate unmatched results using instruments that clinical laboratories already have. Our scientists and engineers leverage different backgrounds to create sophisticated technologies – but enable them with simple workflows that any laboratory can run with consistency.
We have an incredibly talented group of down-to-earth professionals with the experience, drive and creativity that makes Asuragen a world-class global diagnostics company. Our workplace is full of enthusiastic, hardworking, and intelligent co-workers with bold ideas and the tenacity to see them through. Asuragen offers top-notch technology, educational, and business benefits. Science is our passion; it drives us to collaborate, develop and manufacture award-winning tools that help researchers achieve reproducible and consistent results.
By joining Bio-Techne, you’ll join a company committed to enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all its brands, provide tools for researchers to understand, diagnose and treat disease worldwide. Our family of brands creates a unique portfolio of products and services.
Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, stock options, an employee bonus plan, and a tuition reimbursement plan. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
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.
Bio-Techne is an E-Verify Employer in the United States.
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.