Senior Specialist, Quality Control
$106.2k - $167.2kMerck
Merck seeks a Senior Specialist in Quality Control to manage analytical instrumentation, preventive maintenance programs, and regulatory compliance at its Wilson, North Carolina facility. The role involves equipment qualification, vendor coordination, and serving as the site's Empower CDS coordinator while driving operational improvements.
Responsibilities
- Oversee equipment maintenance, calibration programs, and preventive maintenance documentation for laboratory instruments
- Serve as site Empower CDS coordinator, managing validation and maintenance of master data and digital methods
- Lead troubleshooting and problem-solving initiatives to reduce downtime and improve equipment reliability
- Author, review, and approve standard operating procedures, change requests, and technical documentation
- Participate in audits, inspections, and quality investigations; identify and implement corrective actions
Requirements
- Bachelor of Science degree
- Advanced proficiency with analytical and maintenance management software (SAP, EAM, GLIMS, Empower, LabX)
- Deep knowledge of FDA, GMP, and compendial regulatory requirements
- Demonstrated expertise in equipment qualification, validation, and change control processes
- Experience with root cause analysis and quality investigation methodologies
- Proven ability to manage vendor relationships and coordinate cross-functional teams
Vacancy posted 9 days ago
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