Quality Assurance Specialist 2

Merck • Rockville, MD

2d

About The Position

The Quality Assurance Specialist 2 supports Contract Testing Services by ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements. The role performs routine to moderately complex quality tasks under supervision and executes quality systems activities, including document review, investigations, and audit support.

The specialist collaborates with QA, Operations, and other teams to maintain quality standards while developing proficiency in quality systems and regulatory requirements. The scheduled shift is Tuesday through Saturday, 10:00 a.m. to 6:30 p.m. The role does not offer work authorization sponsorship; external applicants must be eligible to work in the United States.

Requirements

• Bachelor’s degree in any discipline and at least 2 years of experience in Quality Assurance in a science field or GxP environment; OR an associate’s degree in any discipline and at least 4 years of relevant experience; OR a high school diploma or GED and at least 6 years of relevant experience.
• Must be eligible to work in the United States; work authorization sponsorship is not offered.

Nice To Haves

• Practical knowledge of 21 CFR 11, 58, 210, and 211; EU GMP; MHRA GLP and GMP; OECD GLP; ICH Q7; ISO 9001; and other applicable regulations, standards, and guidelines.
• Familiarity with international regulations, including EMA and MHRA.
• Proficient knowledge and application of FDA and EU regulations, including cGMP, GLP, and data integrity.
• Strong communication and interpersonal skills.
• Acts ethically and ensures the quality of their own work and that of others.
• Open-mindedness, flexibility, and agility.
• Takes initiative to ensure deadlines are met.
• Ability to work with cross-functional teams and build networks within QA and Operations.
• Ability to collaborate with teams to identify and implement improvements.

Responsibilities

• Review and approve controlled quality documents, including SOPs, laboratory and batch records, and other quality records.
• Review and approve events and deviations, out-of-specification investigations, CAPAs, and change controls under appropriate oversight.
• Participate in root cause analysis using approved problem-solving tools and methodologies.
• Review study-related documents, including protocols, technical specifications, data, and certificates of analysis.
• Support customer audits by coordinating laboratory tours and facilitating document reviews.
• Support continuous improvement initiatives to enhance quality and compliance.
• Conduct internal audits and systems inspections in accordance with applicable cGMP and GLP requirements.
• Review and approve audit responses and applicable follow-up actions or CAPAs within assigned authority and under appropriate oversight.
• Support maintenance of SOPs and adherence to global regulatory requirements, including FDA and EMA requirements, and internal requirements.
• Ensure documentation is accurate, complete, and compliant.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• Life insurance
• Disability insurance
• 401(k) matching program
• Paid time off
• Paid holidays
• May be eligible for short-term or long-term incentive compensation, including cash bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level