Quality Control Analyst

Regeneron Pharmaceuticals • Saratoga Springs, NY

5d • Onsite

About The Position

Regeneron is hiring multiple Quality Control Analysts for its new highly automated drug substance manufacturing facility in Saratoga Springs. The QC Analyst performs chemical, biological, or microbial analyses and sampling on raw materials, products, in-process materials, utilities, environmental monitoring, or stability samples in support of the company’s quality program.

The initial work location is Rensselaer, New York, with permanent work in Saratoga Springs, New York. The initial schedule is full-time, on-site, Monday through Friday, 8:00 a.m. to 4:30 p.m. The permanent schedule is full-time, on-site, rotating 12-hour shifts from 7:00 a.m. to 7:30 p.m., three to four days per week, including one weekend day. 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.

The position requires full cleanroom attire and the ability to perform the physical requirements of the role for the entirety of a shift, potentially up to 10 hours, in a cleanroom environment. The level—Associate QC Analyst, QC Analyst, or Senior QC Analyst I—will be determined based on experience.

Requirements

• Bachelor of Science in Life Sciences or a related field, or an equivalent combination of education and experience.
• Ability to work both the initial Monday-to-Friday schedule and the permanent rotating 12-hour shift schedule, including one weekend day.
• Ability to wear full cleanroom attire, including required gowning items and sanitizing agents, and remove jewelry, makeup, and nail adornments while wearing cleanroom attire.
• Ability to perform physical requirements for the entirety of a shift, potentially up to 10 hours, in a cleanroom environment.
• Ability to perform physical activities that may include bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation, and lifting, pushing, or pulling up to 50 pounds.

Responsibilities

• Gather data and document test results.
• Review test results for compliance with standards and report quality anomalies.
• Comply with pertinent regulatory agency requirements.
• Participate in required GMP training activities.
• Maintain laboratory supplies.
• Conduct testing and sampling on raw materials, in-process materials, products, stability samples, and/or research samples.
• Write and revise control test procedures and standard operating procedures (SOPs).
• Complete test records and review data.
• Calibrate instruments and devices or verify their calibration before use.
• Interact with outside customers or functional peer groups.
• Engage in projects aligned with scientific initiatives.
• Devise or develop analytical methods and techniques.
• Assist in method validation.
• Partner with internal teams to establish the transfer of methodology from R&D.

Benefits

• Student loan paydown program
• Tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture, and well-being programs, including physical and mental health
• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level