Senior Specialist, Quality Assurance

MSD

Senior Specialist in Quality Assurance overseeing API manufacturing compliance for clinical supply at Merck. Conducting audits, approving documents, and ensuring GMP compliance at the Rahway facility.

Posted 7/20/2026full-timeRahway • New Jersey • 🇺🇸 United StatesSenior💰 $106,200 - $167,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance and compliance within the pharmaceutical industry, with a strong focus on cGMP practices, project management, and effective communication across cross-functional teams.

Highest-signal resume keywords

Quality AssuranceCGMP ComplianceProject ManagementAnalytical Method ValidationLeadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ReviewBatch Record ApprovalDocument AuditingSOP DevelopmentData Analysis

Soft Skills

CollaborationProblem-SolvingCommunicationNegotiationAttention to Detail

Tools & Technologies

Microsoft SuiteElectronic Systems

Industry Keywords

Pharmaceutical IndustryRegulatory ComplianceQuality Management SystemCAPAGMP Documentation

About the role

Key responsibilities & impact

Perform quality assurance activities related to API manufacturing in a complex, clinical supply development
Review and/or approve GMP documents
Ensure all API manufactured in compliance with cGMP and regulatory filings
Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product
Make independent batch release or reject decisions
Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
Accountable for all assigned projects and communication of status to the Management Team
Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels
Establish, educate, and enforce standard operating procedures (SOPs) required under GMP
Develop/update SOPs to ensure practices are accurately reflected
Assist in SOP and quality-related system document approval
Support metrics by summarizing findings during documentation reviews
Collect, prepare and analyze data to support quality system metrics and planning
Support compliance activities such as site readiness, audits, inspections, and CAPAs
Support quality risk management activities as facilitator, project lead and/or quality subject matter expert
Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency
Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert
Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables
Exercise broad judgment in making quality decisions and solving complex problems
Escalate issues as needed
Provide meeting coordination, facilitation, scribing, and communication.

Requirements

What you’ll need

Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology)
Minimum of 5 years’ experience with a B.S.
Experience in the pharmaceutical or closely related industry
Experience in one or more functional areas such as quality assurance, analytical laboratories, manufacturing, production support area, equipment/facilities management, regulatory
GMP or related drug regulation knowledge and expertise
Strong leadership, collaboration, teamwork, negotiation, communication, problem-solving and workload management skills
Excellent verbal and written communication including presentation skills
Demonstrated ability to manage projects, priorities, to meet deliverables and timelines
Attention to detail, flexibility, and an awareness of production and associated quality problems
Ability to work in a dynamic environment with rapidly changing needs
Ability to work across functional and sites, with all levels of staff and management
Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
comprehensive package of benefits