Quality Specialist 3 - Quality Systems

Merck•Rockville, MD

About The Position

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.

Requirements

Bachelor's Degree
4+ years' experience in Quality Assurance within a GxP environment.

Nice To Haves

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.

Responsibilities

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