Quality Control Analyst

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're hiring multiple Quality Control (QC) Analysts to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. The QC Analyst performs a variety of chemical/biological/microbial analyses or sampling on raw materials, products, in-process materials, utilities, environmental monitoring, or stability samples in support of the company’s quality program.

Location & Schedule

Initial: Rensselaer, New York, United States
Permanent: Saratoga Springs, New York, United States
Work Model:
- Initial: Full-time, on-site, 1st shift, Mon-Fri, 8am-4:30pm
- Permanent: Full-time, on-site, rotating 12-hour shifts, 7am-7:30pm, 3-4 days per week, includes 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.

Responsibilities

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

Work Environment & Physical Requirements

• 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
• Ability to perform physical requirements for the entirety of the shift (up to 10 hours) in a cleanroom environment
• Physical requirements may include: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation, and ability to lift/push/pull up to 50lbs

Qualifications

• Requires B.S. in Life Sciences or related field; or equivalent combination of education and experience
• Experience Levels:
  - Associate Quality Control Analyst: 0-2 years of experience
  - Quality Control Analyst: 2+ years of experience
  - Senior Quality Control Analyst I: 4+ years of experience
  Level will be determined based on experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture, and well-being programs (including physical & mental health)

Pay

Salary Range (hourly): $24.76 - $44.42