Specialist, Quality Systems & Compliance

Quality Assurance Associate Specialist

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Associate Specialist provides Quality support to both laboratory and manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facilities. The successful candidate must be able to examine issues from various perspectives, provide a hands-on approach to problem solving, and be self-motivated to identify and initiate process improvement projects.

The Quality Assurance Specialist provides support to vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations.

Primary activities could include:

• Perform review of batch records, laboratory records and associated documentation.
• Provide quality guidance and assistance in deviation identification and initiation.
• Perform data review and run reconciliation activities as required (i.e., UV and FIT testing).
• Learn new processes and procedures.
• Perform shift work as required.
• Support housekeeping and self-inspections.
• Perform Quality retain sample management activities, if applicable.

Education Minimum Requirements

High School Diploma or equivalent.

Required Experience and Skills

• Minimum two (2) years' experience in Manufacturing, Maintenance, Military environments, or relative industry experience.
• Must be able to work 12 hour night shift 6:00 pm to 6:00 am; 2-2-3 schedule.

Preferred Experience and Skills

Good interpersonal skills including flexibility and collaboration.

Demonstrated analytical aptitude, critical thinking skills, and problem solving.

Good verbal and written communication skills.

The salary range for this role is $71,900.00 - $.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift: 3rd - Night

Valid Driving License:
No

Hazardous Material(s): NA

Job Posting End Date: 07/4/2026

Requisition : R404840