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.

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.  With the recent acquisitions of Asuragen and ExosomeDx, Bio-Techne has expanded its presence in the molecular diagnostics space. The combination of these businesses into a single Molecular Diagnostics Division provides a set of core capabilities and unique technologies ranging from biomarker discovery to international regulatory expertise and the ability to launch innovative products as both kitted products for international distribution as well as centralized laboratory developed tests.  This division unifies the processes of offering these capabilities and those of the broader Bio-Techne family of brands to pharma partners for projects ranging from biomarker discovery and assay development to full companion diagnostic development and commercialization. 

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 support to manufacturing operations including staging, line inspections, batch record issuance, batch record review and material release.
• 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 and OOS 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.
• Manage the historical files of all manufactured products and archival records including on and offsite storage.
• Supports regulatory and client audits.
• Supports the overall Quality goals and 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 have an incredibly talented group of down-to-earth professionals with the experience, drive and creativity that makes Bio-Techne a world-class global diagnostics company. Our workplace is full of enthusiastic, hardworking, and intelligent people with bold ideas and the determination to see them through. 

Our best-in-class reagents, instrument, custom manufacturing, and diagnostic tests are used throughout a patient’s lifespan by laboratories worldwide. Bio-Techne has locations in Minneapolis, MN, Austin, TX, Boston, MA, Denver, CO and San Jose, CA and all sites offer 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. 

Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, 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. 

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.

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.