Senior QC Specialist: Instrumentation & Empower CDS

Caraway Therapeutics, Inc.

Wilson (NC)

On-site

USD 106,000 - 167,000

Full time

8 days ago

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Job summary

Merck & Co. in the United States seeks a Growth and Improvement-minded Technical Support Senior Specialist in Quality Control to maintain instrumentation, manage preventive maintenance, calibration data, and change control for equipment.

You will coordinate Empower CDS and CMMS tools, collaborate with NASU, GLIMS, and external vendors, ensure GMP compliance, and lead maintenance planning and cost-saving initiatives, with a focus on delivering reliable analytical capabilities.

Qualifications

≥ 4 years in a pharmaceutical laboratory setting.
High proficiency with Empower and related tools.
CMMS knowledge, preferably SAP or EAM.
Experience managing vendors and contractors.
Knowledge of GMP, NDA and related regulations.
Experience with analytical instrumentation (HPLC, GC, KF, etc.)

Responsibilities

Initiating/leading problem solving to reduce downtime and increase equipment reliability.
Timely approval of qualification, change control, procedures and other documents.
Operational SME support for installation of new equipment or modifications.
Manage equipment procurement, validation and qualification.
Maintain equipment preventive maintenance and calibration programs.
Support equipment/process improvements and root cause analysis.