Carex is partnering with a BioTech industry leader to identify an Associate Quality Assurance Engineer based in Madison, WI. This role supports Operations across material receipt, production, process validation, facility qualification, and test method validation to ensure materials and processes meet established quality standards. This position also serves as a subject matter expert for Operations, contributing to investigation management, process improvement, and material release activities while operating with a high degree of independence.
Summary
The Associate Quality Assurance Engineer plays a key role in ensuring compliance with regulatory and quality standards across manufacturing and operational processes. This position collaborates closely with cross-functional teams to evaluate process risks, support validation activities, and maintain adherence to cGMP, ISO, and related requirements. The role combines hands-on quality oversight with continuous improvement initiatives to support safe and effective product distribution.
What You'll Do
- Act as a Quality representative on process improvement initiatives, ensuring compliance with regulatory and internal standards
- Support Operations in completing production documentation and executing test methods to evaluate materials prior to release
- Assess process risks and recommend appropriate mitigation strategies
- Review validation and qualification protocols, ensuring completeness and resolving deficiencies prior to commercial use
- Review equipment calibration records for accuracy and compliance
- Approve updates to SOPs and Manufacturing Work Instructions to align with regulatory requirements (cGMP, ISO, ICH)
- Support Nonconformance Reports and Deviations, including material disposition decisions
- Conduct audits of production and support areas to ensure adherence to internal procedures and regulatory standards
- Serve as a subject matter expert to support day-to-day operational activities and investigations
- Collaborate cross-functionally to drive compliance, quality improvements, and operational excellence
What You'll Bring
- Bachelor’s degree in engineering, biology, chemistry, or a related field (or Associate degree with additional relevant experience)
- 2+ years of experience in a manufacturing environment
- 1+ years of experience applying Quality principles and practices
- Working knowledge of CFR 820, ISO 13485, ISO 9001, and/or cGMP environments
- Strong ability to interpret regulatory requirements and apply them in operational settings
- Excellent communication and interpersonal skills with the ability to collaborate across teams
- Proven ability to manage multiple priorities and work both independently and within cross-functional teams
- Experience in biotech manufacturing, particularly in GMP or ISO13485 environments, preferred
- Ability to meet physical requirements, including lifting up to 40 pounds and working in a production environment
- Ability to work primarily onsite and travel occasionally between locations
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.
#LI-AD1