Pay Range:

Position Summary:  

Position will manage the Quality Management System activities of Bio-Techne's Wallingford site, including but not limited to document control, training, validations, CAPA, NCMRs and deviations among others. This position will lead the qualification process related to the new processes and process improvements may also assist with the software validation process. 

Key Responsibilities:  

• Manage personnel in the department providing guidance, tools and conducting performance discussions 

• Write, review & approve the following as appropriate: SOP, COA, Deviation, & Change Impact Assessment 

• Lead process to ensure compliance with Wallingford Quality Management System. 

• Leads process to solve product and process related issues and non-conformances and optimization 

• Lead process to identify and implement process improvement and optimization.

• Lead quality management system review and improvement process. 

• Approval of all new and updated process validations. 

• Collaborate with development and facilitate new product/process design and validation 

• Follow guidelines and comply with all company safety, quality, and training procedures and regulations 

• Perform additional duties as assigned 

QUALIFICATIONS 

Education and Experience: 

• Bachelor’s degree and 8 or more years of relevant experience 

• Or, Master’s degree in a related field and 2-5 years of relevant experience 

• Demonstrated leadership capacity with 3-5 years of formal or informal leadership experience.  

Knowledge, Skills, and Abilities: 

• Ability to lead a team of various skills levels and background. 

• Working knowledge of Microsoft Word and Excel is required 

• Must be able to work in a fast-faced environment where you will be required to prioritize your own work and the work of others to meet various project deadlines 

• Must be able to analyze data to make effective decisions 

• Must have good verbal and written communication skills, especially across different groups 

• Must have strong organizational skills and attention to detail 

• Must work well independently in an environment that requires strategic decision making 

• Proficient in planning, organizational, and multi-tasking skills to complete assignments in an efficient manner in a fast-paced environment. 

• Must be able to effectively train new employees 

• Must be able to effectively lead new projects, especially across different groups 

• Must stay informed of current trends and developments in area of expertise ​

Working Conditions: 

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment. 

• Standard schedule hours with occasional variation depending on production needs. 

• Onsite work required during standard business hours.  

Physical Requirements: 

• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods. 

• Manual dexterity required for laboratory equipment and fine measurement techniques. 

• Ability to work at a computer for extended periods. 

• Ability to lift and handle materials weighing 5–20 lbs.