Manager, Quality Control

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.

Bio-Techne, Devens currently seeks a Manager, Quality Control who will oversee the management of the day-to-day operations within various Quality Control groups including QC laboratory, Incoming QC inspection, and Documentation Control.  As the manager you will train, guide, and supervise these QC teams, ensuring adequate staffing levels, recruitment, development, appraisal, attendance, disciplinary issues, and quick, effective problem resolution that maximizes efficient productivity and delivers a high level of employee engagement. 

Responsibilities Include:

• Drive training and development of team members and work closely with department Supervisors to ensure the completion of team and individual goals.
• Interface with all applicable internal departments on quality and manufacturing procedures or vendor non-conformances affecting quality and provide input/recommendations as needed.
• Provide hands-on technical support to laboratory investigation, deviations, and non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale.
• Develop and design effective quality plans that increase continuous improvement activities and improve operational effectiveness.
• Align with senior leadership initiatives and support corporate goals for the business.
• Positively engage with personnel to understand challenges and issues through continuous assessment and implement change where necessary. 
• Establish and monitor Quality Control systems and oversee programs for the monitoring of temperature-controlled storage areas identifying critical points in the manufacturing processes where quality checks can be added.
• Participate in New Product Development supporting test methods for new product types.
• Participate in internal and supplier audits.
• Coordinate and oversee instrument acquisition and validation activities participating in budgetary review and capital expenditure process for new instrument requests.
• Prioritize and support CAPA, Complaint, and Non-Conforming Material investigations and prevention planning as assigned.
• Support timely and accurate documentation in support of the various Quality records.

Qualifications:

• Bachelor's degree (BA or BS) in Biology, Chemistry or related science field and minimum 5 years laboratory experience required.
• Training or experience in Quality Control, statistics, and validation experience required.
• Experience in Medical device manufacturing and IVDR
• ASQ certification a plus.
• Managerial experience 5+ years overseeing a team of 10+ preferred.
• Strong math and science background.
• Excellent computer skills, specifically Excel and Word.  Smartsheet experience a plus.
• Experience in cGMP environment and Lean Continuous Improvement a plus.
• Experience working as part of a high-performing interconnected team and a willingness to roll up your sleeves and fix problems in a hands-on manner when needed.
• Reliable transportation and ability to work onsite Monday-Friday

Physical Requirements:

• Remain seated in a normal position for extended periods 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 30 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, 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.