Specialist, Quality Systems & Compliance

Job Overview

Job Title:

Quality Assurance Associate Specialist at Merck & Co., Inc. This role ensures quality and regulatory compliance across manufacturing, laboratory, and supply chain operations for vaccine production.

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

• Support laboratory and manufacturing operations, providing quality guidance and assistance in deviation identification and initiation.
• Review batch records, laboratory records, and associated documentation.
• Perform data review and reconciliation activities as required (e.g., UV and FIT testing).
• Learn new processes and procedures.
• Perform shift work as required, supporting housekeeping and self‑inspections.
• Manage quality retain samples (if applicable).

• High School Diploma or equivalent.
• Minimum two (2) years’ experience in manufacturing, maintenance, military environments, or related industry experience.
• Analytical aptitude, critical thinking, problem‑solving, and communication skills.

• Good interpersonal skills including flexibility and collaboration.
• Experience with aseptic filling, cGMP compliance, quality auditing, root cause analysis, and process improvement projects.

• Analytical Problem Solving
• Aseptic Filling
• cGMP Compliance
• Communication
• Complaint Management
• Decision Making
• Deviation Management
• Global Manufacturing
• Good Manufacturing Practices (GMP)
• Manufacturing
• Oral Communications
• Performance Improvement Plans
• Process Improvement Projects
• Process Improvements
• Quality Assurance (QA)
• Quality Auditing
• Quality Management
• Quality Management Systems (QMS)
• Quality Standards
• Quality Support
• Root Cause Analysis (RCA)
• Sterile Procedures

Salary range: $71,900.00 – $. Eligible for annual bonus and long‑term incentive if applicable. Comprehensive package including medical, dental, vision, retirement, 401(k), paid holidays, vacation, and sick days.

Merck & Co., Inc. is an Equal Employment Opportunity Employer and a federal contractor that complies with affirmative action requirements. We provide opportunities to all employees and applicants irrespective of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We also comply with California, Colorado, and other U.S. state laws regarding equal employment opportunity and the Fair Chance Initiative for hiring.

San Francisco residents will be considered under local ordinance guidelines. Los Angeles residents will also be considered in compliance with the City of Los Angeles’ Fair Chance Initiative for hiring. The job posting is effective until 07/4/2026.