Quality Control Analyst (Overnights)
About The Position
Regeneron is hiring multiple Quality Control Analysts for its new highly automated drug substance manufacturing facility in Saratoga Springs. The role performs chemical, biological, and microbial analyses or sampling of raw materials, products, in-process materials, utilities, environmental monitoring, and stability samples in support of the company’s quality program. The position begins onsite in Rensselaer, New York, on a Monday–Friday, 8:00 a.m.–4:30 p.m. first shift schedule. The permanent work location is Saratoga Springs, New York, with onsite rotating 12-hour overnight shifts from 7:00 p.m. to 7:30 a.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 role requires working in a cleanroom while wearing full cleanroom attire and being able to perform physical requirements for the entirety of a shift, for up to 10 hours, in a cleanroom environment. The successful candidate must be able to remove jewelry, makeup, and nail adornments while wearing cleanroom attire. The required experience varies by level: Associate Quality Control Analyst requires 0–2 years, Quality Control Analyst requires 2 or more years, and Senior Quality Control Analyst I requires 4 or more years. Level will be determined based on experience. The role requires a B.S. in Life Sciences or a related field, or an equivalent combination of education and experience.
Requirements
- B.S. in Life Sciences or a related field, or an equivalent combination of education and experience.
- Candidates must be able to work both the initial Monday–Friday first shift schedule and the permanent rotating overnight schedule.
- Associate Quality Control Analyst: 0–2 years of experience.
- Quality Control Analyst: 2 or more years of experience.
- Senior Quality Control Analyst I: 4 or more years of experience.
- Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments while wearing it.
- Ability to perform physical requirements for the entirety of a shift, 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, and hand manipulation.
- Ability to lift, push, or pull 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.
- Participate in projects aligned with scientific initiatives.
- Devise or develop new analytical methods and techniques.
- Assist in method validation.
- Partner with internal teams to establish 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
- Annual bonuses or other incentive plans, depending on country and role
- Equity awards, depending on country and role
- Pension or retirement benefits, depending on country and role
- 401(k) company match, depending on country and role
- Health and wellness programs, depending on country and role
- Fitness centers, depending on country and role
- Medical, dental, vision, life, and disability insurance benefits, depending on country and role
- Paid time off, depending on country and role
- Family support benefits, depending on country and role
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
