Quality Systems Lead – CAPA & Process Improvement

biotechne

Wallingford (CT)

On-site

USD 92,000 - 151,000

Full time

4 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Long-term disability

Pet insurance

Legal shield

401k with company match

Employee stock purchase plan

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Dependent Care FSA

Mentorship programs

Tuition reimbursement

Internship programs

Volunteer paid time off

Job summary

Bio-Techne is seeking an experienced Quality Manager for the Wallingford site to oversee the Quality Management System, including document control, training, validations, CAPA, NCMRs and deviations. You will lead qualification of new processes and support software validation as needed.

The role requires guiding a team, ensuring compliance with QMS, and coordinating with development on new product design and validation.

Qualifications

Bachelor's degree and 8+ years of relevant experience.
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.

Responsibilities

Manage personnel in the department providing guidance, tools and conducting performance discussions.
Write, review & approve SOPs, COA, Deviation, & Change Impact Assessment.
Lead process to ensure compliance with Wallingford Quality Management System.
Lead quality management system review and improvement process.
Collaborate with development and facilitate new product/process design and validation.