By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Bio-Techne’s Diagnostic Reagents Division has been providing essential products to the in vitro diagnostics industry for over 40 years. We supply quality controls and reagents for clinical laboratory and point-of-care testing, along with custom products to other companies serving the IVD market.

Position Summary:

The Senior Quality Systems Administrator will be primarily responsible for fulfilling the Quality Assurance function at Bionostics as an integral part of the Bio-Techne Diagnostics Division Quality Assurance team with a focus on the following: Internal quality audits, supplier audits, OEM and third-party audits, and all audits and inspections of quality management system according to FDA CF820 and ISO13485.

The Senior Quality Systems Administrator must understand and apply CFR 820 guidance, cGMP and ISO standards. This position closely collaborates with the Sales, Marketing, Supply Chain, Manufacturing, Manufacturing Engineering, Formulation & Filling, and Q.C. departments.

Responsibilities:

• Primarily responsible for performing internal audits of Bio-Techne DRD’s quality system to ensure compliance to the FDA Quality System Regulation and applicable ISO standards.

• Prepare Management Review Quality System information.

• Act as site management representative.

• Deputy person responsible for regulatory compliance (PRRC) IVDR.

• Maintain the Quality Objectives process via MasterControl.

• Participate in the creation and modification of Quality Agreements with OEM customers.

• Participate in external supplier audits; generate audit reports and follow-up on audit observations.

• Provide support to other sites in the diagnostics division for internal audits/ combined supplier audits and collaborate on divisional initiatives as needed.

• Review and evaluate corrective action plans provided by the auditees and serve as a source for interpretation of regulations.

• Lead OEM, third-party audits and agency inspections.

• Contribute to the ongoing development of auditing procedures and tools.

• Participate in the CAPA/ Complaint team as key contributor.

• Communicate directly with OEM QA representatives requesting support as legal manufacturer during audits and respond to inquiries in a timely manner.

• Ensure compliance to current state regulations and guidance documents at Bio-Techne/DRD.

• Review and approve Engineering Change Orders, manufacturing waivers, rework, risk assessments, rework, validation protocols and reports for quality impact as needed to ensure internal compliance to our Quality Management System requirements.

• Align with senior leadership initiatives and support corporate goals for the business.

• Follows company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job function.

• Manages time well and will put in extended time as needed.

• Willingness to accept changes in work from day-to-day within reasonable and expected boundaries.

• Perform other duties as assigned.

Qualifications

Qualifications:

• Bachelor’s degree in a technical or scientific field and/or equivalent education and experience required.

• Knowledge of the FDA Quality System Regulation and ISO standards required.

• Minimum 3 – 5 years experience working in QA role for company producing In Vitro Diagnostics (IVDs), Medical Devices, or Pharmaceutical products or significant relative experience required.

• Must have strong written and verbal communication skills.

• Must be a self-starter.

• Must have strong organizational skills.

• Advanced level proficiency in tools such as SmartSheet and Excel strongly preferred.

• ASQ or other certification training for auditing helpful but not required.

Minimum Physical Requirements:

• Remain seated in a normal position for extended periods of time up to 8 hours.

• Walk, stand, and move about at various times in the workday.

• Reach up and out with hands and arms.

• Talk and hear, verbally express information.

• Keyboard, 10 keys for extended periods.

• Repetitive motion; hands.

• Lift up to 25 pounds and carry at a distance of 10 feet.

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!

• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.

• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, tuition reimbursement, 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 foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

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.