Associate Specialist, Quality Assurance

Responsibilities
- Serve as Quality Integrated Process Team (IPT) Representative for Fermentation/Downstream and Single Use Bioreactors (SUBs) manufacturing.
- Review/approve batch records; prepare documentation and ensure compliance with SOPs/standards.
- Provide generalist Quality support to production; resolve minor documentation issues per SOP.
- Address major issues not defined by SOP; represent Quality in daily Tier 1 meetings.
- Support continuous improvement with IPT members; enable scale-up initiation; backup other QA areas.
- Support document filing/archival.
- Deviation management/CAPA: support investigations (root cause/impact), assess/disposition impacted products, support event/CAPA classifications and reviews, complete assigned CAPA, and follow up to completion.
- Change management: support/track change control documentation, complete assigned actions, review/approve change controls, revise/update documents and procedures.
- Inspection readiness: conduct monthly Quality Gemba walks; maintain site inspection readiness; support Animal Health Quality Manual self-inspection updates.
- Training: complete assigned training; cross-train in other QA functions.

Education
- Associate’s degree + 5 years relevant industry experience (required).
- Bachelor’s degree required; science degree preferred.

Required qualifications/skills
- 2+ years Quality experience in a regulated industry; strong written/verbal communication; investigations/risk assessment/regulatory inspection experience; technical writing; SAP/Aera/Reliance (or similar); attention to detail; decision-making/escalation; problem-solving.

Preferred
- Vaccine manufacturing/testing; strong microbiology; USDA regulations/inspections/Animal Health Quality Manual; project management.

Benefits (explicitly stated)
- Medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.

Application
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).