Quality Control Analyst

Regeneron Pharmaceuticals, Inc.; City of Saratoga Springs (NY); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Relocation assistance

Student loan paydown program

Tuition reimbursement

Family care benefits

Inclusion, culture and well-being

Job summary

Regeneron Pharmaceuticals, Inc. is hiring multiple Quality Control (QC) Analysts for our new automated drug substance facility in Saratoga Springs, NY. Positions include on-site, full-time roles with day and rotating 12-hour shifts depending on schedule.

You will gather data, review test results for compliance, and help maintain regulatory documentation while supporting method validation and transfer from R&D. Relocation assistance may be provided where applicable.

Qualifications

• BS in Life Sciences or related field required.
• 2+ years of QC experience for Analyst level; 4+ years for Senior Analyst.
• Experience with GMP regulations and documentation.

Responsibilities

• Gather data and document test results.
• Review results for compliance and report anomalies.
• Maintain lab supplies and equipment.
• Conduct testing on raw materials, in-process, and finished products.
• Write/revise test procedures and SOPs.
• Complete test records and data reviews.
• Calibrate instruments prior to use.
• Assist in method validation and transfer from R&D.

Skills

Data collection

Test result review

GMP training

SOP writing

Instrument calibration

Method development

Cross-team communication

Education

BS in Life Sciences

Tools

Analytical instruments

Job description

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.

When & where:

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

Work model:

• Initial: full time, on-site 1st, 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.

What you'll do:

• Gather data and documents test results
• Review test results to ensure compliance with standards; reports 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 reviews data
• Calibrate or verify calibration of instruments/devices prior to use
• Interact with outside customers or functional peer groups
• Engage in exciting projects aligning to 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

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
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

Let's find out if we're a fit:

• Requires B.S in Life Sciences or related field; or equivalent combination of education and experience 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

Thrive today. Grow Tomorrow.

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

Does this sound like you? 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/ .