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.
Position Summary:
The responsibilities of the Quality Assurance Specialist position are to assist senior quality assurance staff to create an environment that meets the compliance standards of Bio-Techne’s governing bodies. The Quality Assurance Specialist will understand and follow appropriate quality protocols to meet compliance standards.
Key Responsibilities:
- Participate in team meetings as a quality representative, assist in management of quality issues and offer input representing quality assurance (new product design, data reviews or root cause investigations)
- Work collaboratively with all functions to ensure understanding and conformance with quality requirements
- Prepares reports and necessary documentation to internal and external stakeholders to include
- complaint investigations, supplier corrective action requests, corrective and preventative actions
- Assist and support compliance of the quality systems, by monitoring conformance to appropriate standards and procedures
- Responsible for monitoring equipment control, supplier management, batch record review and release quality records control, input into management review and other quality system related processes
- Propose process improvements and areas for improvement to supervisor
- Follows company policies and practices, understand appropriate lab protocols and follow standard operating procedures (SOPs) including regulatory awareness of chemical handling and hazards, compliance, and proper use of equipment
- Performs additional duties as assigned
Qualifications
Education and Experience:
- An Associate degree with 3-5 years of relevant experience;
- Or, a Bachelors degree with up to 3 years of relevant experience
Knowledge, Skills, and Abilities:
- Attention to detail and organizational skills are required
- Working knowledge of Microsoft Word and Excel are required
- Computer entry, typing, or electronic document filing skills are require
- Must be able to work in a fast-paced environment where multitasking is required
- Must have excellent verbal and written communication skills
- Knowledge of technical, regulatory, quality and production management systems
- Knowledge of documentation principles and processes
- Skills in accuracy, clarity and proofreading
- Skills in problem solving, identifying root cause and appropriately evaluate a course of actions
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 .