Quality Control Operations Specialist

BioSpace; City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron in Saratoga Springs, NY is hiring QC Operations Specialists for a new highly automated drug substance manufacturing facility. The role covers instrument troubleshooting, method support, and deviation investigations in a GMP setting.

You will work with HPLC/GC and other analytical tools, maintain documentation, and support CAPAs and IQ/OQ/PQ protocols as needed. This onsite position features two shift models and strict gowning requirements.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may substitute.
• 2+ years of relevant QC lab operations experience for the base level; more for senior levels.
• Experience with GMP environments and analytical instrumentation preferred.
• Familiarity with cGMP (21 CFR Part 11 & 211), Good Documentation Practices, and ALCOA+ data integrity.

Responsibilities

• Serve as first contact for analysts on instrument, software, and workflow issues during testing.
• Support analysts during first executions of new methods, instruments, or workflows.
• Communicate recurring issues and testing impact across shifts and with Lab Operations.
• Troubleshoot hardware, firmware, and software on chromatography systems, plate readers, balances, and other QC instruments.
• Coordinate service visits, preventive maintenance, calibration with vendors, and document instrument status.
• Maintain logbooks and instrument records per site procedures and document deviations.

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

HPLC

GC

Spectrophotometers

Balances

LIMS connectivity

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Control (QC) Operations Specialists to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs.

When & Where

Location: Initial: Rensselaer, New York, United States. Permanent: Saratoga Springs, New York, United States.

Work model: Initial: 1st, Mon-Fri, 8am-4:30pm. Permanent: 12-hour shifts, 7am-7:30pm, alternating 34 days per week, including 1 weekend day. Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.

Discover Your Role

• Serve as the first point of contact for analysts on instrument, software, and workflow issues during testing; triage issues and resolve them or elevate to the appropriate support group
• Support analysts during first executions of new methods, instruments, or workflows, in coordination with training leads
• Communicate recurring issues and testing impact to lab leads and the Lab Operations team, including across shift handoffs
• Troubleshoot hardware, firmware, and software issues on chromatography systems, plate readers, balances, and other QC instrumentation
• Work with appropriate groups to coordinate service visits, preventive maintenance, and calibration with vendors. Confirm instruments are returned to service with required documentation
• Maintain instrument status, logbooks, and equipment records in accordance with site procedures
• Work with IT to resolve instrument connectivity issues, including CDS and LIMS interfaces and networked data acquisition
• Support laboratory investigations (OOS, OOT, invalid assays) and deviations by gathering data, reviewing audit trails and instrument records, and participating in root cause analysis
• Execute troubleshooting and investigational testing under approved investigation plans
• Implement assigned CAPAs and support effectiveness checks; track actions to closure
• Track trends in instrument failures, invalid assays, and recurring errors
• Execute IQ/OQ/PQ, method verification, engineering run, and dry-run protocols as assigned, with documentation that meets Good Documentation Practices
• Document and expedite discrepancies and deviations identified during protocol execution
• Support post-implementation monitoring after new instruments, technologies, or lab upgrades are handed over to testing
• Participate in process mapping of testing, sample management, and reagent preparation workflows; provide floor-level observations, timing data, and pain points.
• Support implementation of approved workflow changes, including bench layout, sample handling, and procedural updates, under change control
• Draft or revise SOPs, work instructions, and job aids so they reflect how work is performed on the floor

The Environment And Physical Rhythms Of The Role

• Gowning: Full cleanroom attire (examples may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This Role Requires

• BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education.
• Associate QC Lab Operations Specialist: 0-2+ years of relevant experience.
• QC Lab Operations Specialist: 2+ years of relevant experience.
• Sr. QC Lab Operations Specialist: 5+ years of relevant experience.
• Level will be determined based on experience.
• Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is preferred.
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211), Good Documentation Practices, and data integrity principles (ALCOA+) as applied to QC laboratories.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country in which the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

Salary Range (annually)
$62,355.00 - $131,300.00