Quality Assurance Advisor, Sterility Assurance

About the role

For our client, we are seeking a Quality Assurance Advisor, Sterility Assurance to join the team of a leader in the Pharmaceuticals & Biotech space. This role will provide specialized quality and sterility assurance expertise to support compliant manufacturing operations in a highly regulated environment. You will collaborate across functions to strengthen contamination control, validation, and qualification practices while helping ensure readiness for regulatory inspections. The position also supports investigation, troubleshooting, and corrective action efforts that protect product quality and operational consistency.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Provide technical expertise in process, aseptic, cleaning validation, and contamination control strategy
• Collaborate to finalize validation and qualification requirements for facilities and systems
• Develop functional procedures for contamination control and validation plans
• Assist in troubleshooting and provide support during regulatory inspections
• Oversee revalidation and qualification activities and support corrective actions

Qualifications

• B.S. in engineering, microbiology, biology, or a related field
• 10+ years of experience in parenteral, biological, or vaccine manufacturing
• Expertise in environmental monitoring and aseptic processing
• Knowledge of FDA, EU GMP, USDA, and CFIA standards

Benefits

• Comprehensive benefits package focused on employee well-being
• Relocation packages available
• Two weeklong shutdowns in summer and year-end
• 8-week parental leave
• Multiple employee resource groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

Pay

$110,000 – $130,000 annually