Quality Specialist 3 – Quality Systems

Merck KGaA; Rockville (MD); On-site; USD 71,000 - 106,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

Merck KGaA in Rockville, MD is seeking a Quality Specialist 3 to support Contract Testing Services by ensuring cGMP/GLP compliance and regulatory requirements. The role performs document review, investigations, audit support, and CAPA activities.

You will lead root cause analysis, host change control meetings, approve quality records, support regulatory inspections, and contribute to continuous improvement across QA and Operations.

Qualifications

• Bachelor's degree in a related field required.
• 4 years' experience in Quality Assurance within a GxP environment.
• Strong knowledge of cGMP/GLP and regulatory requirements.

Responsibilities

• Author, review and approve controlled quality documents (SOPs, records).
• Review and approve events/deviations and investigations.
• Lead root cause analysis using approved tools.
• Own and review CAPAs and monitor effectiveness.
• Support customer discussions related to investigations and CAPAs.
• Host change control meetings and approve changes.
• Develop training materials and train staff on QMS records.
• Review study documents (protocols, specs, data).
• Host audits and respond to audit findings with follow-ups.
• Support regulatory inspections and readiness.

Skills

Quality Assurance

cGMP knowledge

Communication skills

Regulatory knowledge

Education

Bachelor's Degree

Tools

GxP systems

Audit management software

Job description

Your Role:

The Quality Specialist 3 supports our Contract Testing Services by ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements. This role independently performs routine to moderately complex quality tasks. Responsible for executing quality systems activities, including document review, investigations, and audit support. Works collaboratively with various teams including QA and Operations to support compliance and maintain quality standards while developing proficiency in quality systems and regulatory requirements.

• Author, review and/or approve controlled quality documents, including SOPs, laboratory and batch records, and other quality records.

• Review and approve events/deviations, out-of-specification investigations, complaints, and other investigations of varying impact and criticality.

• Lead root cause analysis via use of approved tools (e.g., Fishbone, GEMBA).

• Own and/or review and approve CAPAs and conduct trend analysis to facilitate verification of CAPA effectiveness.

• Support customer discussions related to investigations and CAPAs.

• Host change control committee meetings, review and approve change controls.

• Assist with developing training material and provide training for review and approval of QMS records and other controlled quality documents.

• Review study-related documents (e.g., protocols, technical specifications, data, certificates of analysis).

• Host customer, internal and/or supplier audits in accordance with applicable cGMP/GLP requirements.

• Review and approve audit responses and applicable follow-up actions/CAPAs.

• Support regulatory inspections and maintain awareness of inspection readiness requirements.

• Support continuous improvement initiatives to enhance quality and compliance.

• Support maintenance of SOPs and adherence to global regulatory (e.g., FDA, EMA) and internal requirements.

• Ensure accuracy, completeness, and compliance of documentation.

• Audit and inspection readiness

Who You Are

Minimum Qualifications:

• Bachelor’s Degree
• 4 years’ experience in Quality Assurance within a GxP environment.

Preferred Qualifications:

• Practical knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines.
• Excellent communication and interpersonal skills.
• Ensures quality of own work in an ethical manner.
• Open-minded, flexible and works with agility.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.
• Willing to embrace and implement change on a global scale.

Pay Range for this position: $70,800-106,200 annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

RSREMD

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!