QC Analytics & Lab Operations Specialist

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is hiring a Analytical Technology & Operations Specialist for the Quality Control team at our Saratoga Springs facility.

The role supports lab workflows, equipment integration, and validation activities within cGMP frameworks. You will document requirements, assist with IQ/OQ/PQ, and help ensure data integrity across lab systems while coordinating instrument delivery and test activities.

Qualifications

• Familiarity with data integrity principles (ALCOA+) and GxP requirements.
• Exposure to laboratory system integration CDS, LIMS, instrument interfacing, or networked data acquisition preferred.

Responsibilities

• Gather and document inputs to the assay-to-space model for the assigned area — equipment lists, footprint measurements, bench linear feet.
• Support development of User Requirement Specification content by documenting equipment and network/instrument integration details; elevate integration decisions.
• Help maintain integration documentation for laboratory systems connecting to the lab bus, flagging any data integrity or control gaps.
• Document material, sample, and personnel flow for the assigned area — receipt through login, preparation, analysis, retain, and waste — based on approved process maps.
• Support data integrity risk and gap assessment activities by collecting evidence, completing checklists, and organizing findings for the Senior Specialist’s review.
• Prepare supporting materials and impact documentation for design reviews and proposed value-engineering changes.
• Coordinate day-to-day logistics for instrument delivery, installation, and FAT/SAT activities against the first test-date schedule.
• Execute qualification protocols and pre-defined acceptance criteria testing for lab critical functionality.
• Support LIMS configuration and laboratory digital integration tasks.
• Assist in maintaining integration requirement documentation for lab bus–connected systems, escalating any design-versus-installation discrepancies.
• Draft and revise SOPs for the assigned space — access and gowning, sample receipt and handling, instrument operation, cleaning and sanitization, waste, cold chain, and retain management.
• Participate in and help execute dry runs of the sample-to-result path, and support engineering runs for the assigned area.
• Provide day-to-day post-handover support to the site QC testing team - triaging routine issues and helping execute change control and corrective actions, escalating complex or ambiguous issues to the Senior Specialist

Skills

Data integrity

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

LIMS

Instrument interfacing

Job description

Regeneron Pharmaceuticals, Inc. is hiring a Analytical Technology & Operations Specialist for the Quality Control team at our Saratoga Springs facility.

The role supports lab workflows, equipment integration, and validation activities within cGMP frameworks. You will document requirements, assist with IQ/OQ/PQ, and help ensure data integrity across lab systems while coordinating instrument delivery and test activities.