Associate Lead I – Biomanufacturing Compliance, Investigator - Deviations
On-siteMadison, Wisconsin, United States
Job Summary
Author and revise deviation records, preventative actions, and related cGMP documents under minimal supervision while tracking open investigations and providing timely status updates. Develop familiarity with upstream, downstream, materials management, and production technologies to ensure accurate completion of responsibilities. Engage in initiatives to improve process compliance culture, actively participate in inspection readiness activities, and provide guidance on revising Standard Operating Procedures when gaps are identified. Support internal and client audits as needed and exhibit professional behavior with internal and external associates. Perform other duties as assigned while adhering to Environmental Health and Safety responsibilities.
Required Qualifications
- High School Diploma or GED with at least 4+ years of related experience
- Associate's degree in STEM with 1+ years of related experience
- Experience in deviation writing
- Experience with Root Cause Analysis
- Experience with Corrective and Preventive Action implementation
- Proficiency in Microsoft Office
- Ability to learn and use quality and scientific systems such as TrackWise, ComplianceWire, JD Edwards, and Unicorn
- Ability to apply cGMP principles and best practices
- Foundational knowledge of manufacturing and laboratory operations
- Ability to learn new processes and techniques
- Experience with deviation investigations
- Experience authoring and editing Standard Operating Procedures
- Ability to see, hear, read, and write clear English
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen
- Reaching with hands and arms
- Talking, writing, listening
- Occasional stooping, kneeling, crouching, bending, carrying, grasping
- Frequent lifting and/or moving up to 10 pounds
- Occasional lifting and/or moving up to 50 pounds
- Must comply with Environmental Health and Safety responsibilities
- Location: Madison, WI
- 100% Onsite
- Shift: Mon-Friday, core hours 9am-4pm
Desired Qualifications
- Experience in large-scale manufacturing in upstream or downstream for biological drug products in a GMP environment
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