Bio-Techne is a supplier of tools for life science research, therapeutic manufacturing, and clinical diagnostics. They are seeking a Quality Assurance Specialist to engage in label design, perform internal audits, and support various Quality Assurance activities to ensure compliance and efficiency.
Perform label design, label feasibility testing, and label approval.
Optimize label and printing processes.
Assist with label printing issues.
Assist with the management of SmartSolve eQMS system including creating/revising SOPs; creating, updating, & disabling user profiles; assisting with validation of modules; and maintaining current QMS practices.
Troubleshooting and administrative responsibilities in ComplianceWire (training software) including management of training curriculums, creating new training items, and maintaining records of training compliance.
Perform Supplier Qualifications.
Assist with QA improvement projects.
Perform internal audits.
Perform other tasks as assigned.
Qualification
Required
Bachelor’s degree in Biology related disciplines which provides for the background necessary to perform the work
0 to 5 years of experience in Quality Assurance
Strong organizational skills
Detail orientation
Critical thinking skills
Must respond to inquiry and requests in a timely manner
Working knowledge of Microsoft Word and Excel
Computer entry and/or typing skills
Must be able to work in a fast-paced environment
Multi-tasking abilities
Good communication skills, both verbally and in writing
Preferred
Knowledge of ISO13485, ISO9001 and MDSAP Compliance
Knowledge of Quality Assurance and Regulatory Affairs principles
Knowledge of safety and company procedures and practices
Knowledge of lab equipment & techniques
Skills in managing projects
Skills in coordination with Manufacturing departments
Skills in problem solving; including the ability to identify and appropriately evaluate a course of action
Skills in trouble shooting and critical thinking
Ability to be flexible
Ability to act independently on routine assignments or projects
Ability to plan, organize and multi-task to complete assignments in an efficient manner
Ability to communicate professionally, both oral and written
Ability to pay attention to details and perform at a high-level accuracy
Ability to work independently and with a team
Ability to work hours that conform to standard business operations (8:00 A.M. to 5:00 P.M.)
Benefits
Medical
Dental
Vision
Life
Short-term disability
Long-term disability
Pet
Legal and ID shield
401k plans
Employee stock purchase plan (ESPP)
Health Saving Account (HSA)
Flexible Spending Account (FSA)
Dependent Care FSA
Mentorship
Promotional opportunities
Training and development
Tuition reimbursement
Internship programs
Employee resource groups
Volunteer paid time off
Employee events
Charity drives
Accrued leave policy
Paid holidays
Paid time off
Paid parental leave
Bio-Techne is a supplier of tools for life science research, therapeutic manufacturing, and clinical diagnostics.
