Position Summary:
Manage the Quality Management System activities of Bio-Techne's Wallingford site, including document control, training, validations, CAPA, NCMRs, and deviations. Lead the qualification process related to new processes; may also assist with software validation.
Key Responsibilities:
- Manage personnel in the department, providing guidance, tools, and conducting performance discussions
- Write, review, and approve SOPs, COAs, deviations, and change impact assessments
- Lead processes to ensure compliance with the Wallingford Quality Management System
- Lead processes to solve product/process issues, non-conformances, and optimization
- Identify, implement, and optimize process improvements
- Lead quality management system review and improvement
- Approve new and updated process validations
- Collaborate with development to facilitate new product/process design and validation
- Follow safety, quality, and training procedures and regulations
- Perform additional duties as assigned
Qualifications:
Education and Experience:
- Bachelorβs degree + 8+ years of relevant experience
- Or Masterβs degree in a related field + 2β5 years of relevant experience
- Demonstrated leadership capacity (3β5 years formal or informal)
Knowledge, Skills, and Abilities:
- Ability to lead a team
- Working knowledge of Microsoft Word and Excel
- Ability to work in a fast-paced environment and prioritize to meet deadlines
- Data analysis to make effective decisions
- Strong verbal and written communication
- Organizational skills and attention to detail
- Ability to work independently for strategic decision-making
- Planning/organizational/multi-tasking
- Ability to train new employees and lead new projects across groups
- Stay current on trends in area of expertise
Working Conditions/Physical Requirements:
- Laboratory/production environment exposure to chemicals and lab equipment; onsite during standard business hours
- Stand/walk and perform repetitive lab tasks; manual dexterity; computer work; lift 5β20 lbs