Senior QC Instrumentation Lead

Merck & Co.

Holly Springs (NC)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a Sr. Specialist 2, QC Instrumentation, to own the lifecycle of QC analytical instruments.

You will lead qualification, operation, maintenance, and decommissioning with minimal supervision, ensuring data integrity and regulatory compliance across functions and with external vendors. The role requires extensive hands-on experience with analytical instrumentation (UPLC/HPLC, iCIEF, Western Blot, qPCR, Mass Spec) and a GMP background.

Qualifications

Bachelor’s degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 5+ years GMP experience.
Master’s degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 3+ years GMP experience.
PhD in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 1+ years GMP experience.
3+ years of experience in a GMP environment.
Hands-on experience with analytical instrumentation including UPLC/HPLC, Capillary Electrophoresis/iCIEF, Gel Electrophoresis/Western Blot, Plate Readers, qPCR, Spectrophotometry, and Mass Spectrometry

Responsibilities

Manage the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation.
Ensure QC equipment and instruments adhere to applicable regulatory guidelines, data integrity expectations, and site policies.
Develop, author, and review SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports.
Lead data integrity initiatives for analytical instruments, including periodic reviews to ensure ongoing compliance.
Recommend user roles and privileges to uphold data integrity; design instrument operating instructions and preventive maintenance plans.
Execute and evaluate periodic reviews of QC instruments and their control software; monitor ongoing performance and drive process improvements.
Partner with vendors to plan and oversee instrument maintenance activities.
Initiate and oversee follow‑up on excursions and deviations; manage CAPAs related to analytical instruments.
Provide guidance to stakeholders and address issues related to QC analytical instruments; manage a variety of routine tasks while balancing project priorities.
Collaborate with cross‑functional partners including end users, Validation, Labware Specialists, and Quality Assurance to ensure effective, compliant instrument operations.
Perform other duties, as assigned.