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Quality Assurance Specialist
- Overview
We are seeking experienced Quality Assurance (QA) Specialists to support pharmaceutical, biotechnology, and medical device organizations in cGMP-regulated environments. This is a hands-on role focused on ensuring compliance, maintaining quality systems, and supporting manufacturing and operational excellence.
Key Responsibilities
Support and maintain Quality Management Systems (QMS)
Review and approve batch records, SOPs, and validation documentation
Manage and investigate deviations, CAPAs, and change controls
Ensure compliance with FDA, cGMP, and internal quality standards
Participate in internal audits, external audits, and regulatory inspections
Collaborate with manufacturing, validation, and engineering teams
Support training, documentation control, and quality metrics tracking
Assist in continuous improvement and compliance initiatives
Qualifications
Bachelor’s degree in Life Sciences, Engineering, or related field
3+ years of QA experience in a cGMP-regulated environment
Strong knowledge of cGMP regulations and FDA requirements
Experience with deviations, CAPA, and change control systems
Strong attention to detail and documentation skills
Ability to work cross-functionally in a fast-paced environment
Preferred Experience
Background in pharmaceutical, biotech, or medical device industries
Experience supporting manufacturing floor QA or QA operations
Familiarity with electronic QMS systems (eQMS)
Experience with validation review or audit readiness activities
What This Role Offers
Exposure to critical quality operations within regulated environments
Opportunity to support high-impact manufacturing and compliance initiatives
Long-term project opportunities with cross-functional collaboration
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