Merck · 15 hours ago
Senior Specialist, Quality Assurance - Non-Sterile Product Quality Operations
Rahway, NJ
Full-time
Onsite
Senior Level
$106K/yr - $167K/yr
5+ years expMerck is a global leader in the pharmaceutical industry, and they are seeking a Senior Specialist in Quality Assurance to support GMP clinical supply operations. The role involves independent approval of documentation, conducting audits, and ensuring compliance with regulatory standards while supporting various clinical supply projects.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Advise supported areas on requirements for all assigned project responsibilities as related to quality and our company's standards and communicate project status to management
Act as Development Quality representative for in-house or outsourced manufacturing for clinical supplies. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc
Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval
Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables
Independently prioritize work in support of multiple projects including clinical supply disposition commitments and maintenance of a cGMP posture within Global Development Quality
Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection
Qualification
Required
B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology); advanced degree preferred
Minimum 5 years of experience in Pharmaceutical or related industry
Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development
Strong leadership skills with the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives
Excellent verbal and written communication including presentation skills
GMP or related drug regulation knowledge and expertise
Ability to independently manage multiple priorities and projects
Must be able to work on first and second shift
Preferred
Experience in non-sterile and/or sterile drug product manufacture/testing
Experience in excipient/component release requirements/testing
Experience with manufacturing investigations and CAPA's
Familiarity with R&D or clinical supply areas and processes
Knowledge and competency in SAP
Experience with regulatory or QP inspections
Superior skills in collaboration, teamwork, and conflict management
Strong analytical problem-solving skills
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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