Associate Specialist, Quality Systems & Compliance

Job Description

The Quality Assurance Associate Specialist provides support to vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations. The role ensures that every material inside our products is manufactured, processed, tested, packaged, stored, and distributed in accordance with our high quality standards and regulatory requirements.

Must be able to work a 12‑hour night shift (6:00 pm – 6:00 am) on a 2‑2‑3 schedule.

• 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 (e.g., UV and FIT testing).
• Learn new processes and procedures.
• Support housekeeping and self‑inspections.
• Perform quality retain sample management activities, if applicable.

• High School Diploma or equivalent.
• Minimum two (2) years of experience in manufacturing, maintenance, military environments, or related industry.
• Strong analytical, critical thinking, and problem‑solving skills.
• Good verbal and written communication skills.
• Must be able to work a 12‑hour night shift (6:00 pm – 6:00 am) on a 2‑2‑3 schedule.
• US or Puerto Rico resident (location requirement).

• Interpersonal flexibility and collaboration.
• Experience with cGMP compliance, deviation management, root cause analysis, and process improvement projects.

Salary range: $71,900.00 – $. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, other insurance, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.

If you need an accommodation during the application or hiring process, please let us know.