Quality Control Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 75,000 - 102,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Fitness centers

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a QC Specialist for 1st shift (Mon-Fri, 8:00am–4:30pm) to review analytical test data and support External Testing operations.

You will evaluate method qualification/verification documentation and ensure data meets ALCOA+ principles, while maintaining strict adherence to cGMP standards across multiple analytical platforms.

Qualifications

• BS/BA in a scientific field or equivalent combination of education and experience.
• Minimum 2 years of related experience for Specialist level.
• Experience in GMP environment with data review responsibilities.

Responsibilities

• Review analytical test results for release, in-process and stability testing.
• Ensure data compliance with cGMP, GDP, FDA/EMA/ICH guidelines.
• Support QA events, deviations and investigations as required.
• Provide guidance to QC analysts on Good Documentation Practices.

Skills

Data review

cGMP

ALCOA+

Analytical methods

HPLC

pH measurement

iCIEF

ELISA

SEC

CE-SDS

Education

BS/BA in a scientific field

Tools

Liquid chromatography

iCIEF

ELISA

SEC

CE-SDS

pH measurement

Job description

Role Overview

Quality Control External Testing is currently looking to fill a QC Specialist position with a 1st shift, Monday-Friday, 8:00am – 4:30pm schedule. This position performs data review of analytical test results to support QC External Testing operations. In this role, a typical day might include the following:

• Conduct comprehensive data review for Release, In-Process, and Stability testing in Advanced Therapies, ensuring adherence to quality standards.
• Perform thorough evaluation of analytical test method Qualification, Verification, Transfer, and Validation documentation.
• Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through meticulous review processes.
• Verify analytical data meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
• Monitor testing compliance with established laboratory procedures, test methods, and approved protocols.
• Collaborate with laboratory personnel to address documentation errors and omissions while fostering a cGMP-oriented culture.
• Demonstrate exceptional attention to detail, focus, and multitasking capabilities when reviewing complex analytical laboratory data.
• Apply strong technical expertise in various analytical methodologies including liquid chromatography, pH measurement, iCIEF, ELISA, SEC, and CE-SDS.
• Engage with team members to implement continuous improvements to data review processes and methodologies.
• Provide strategic guidance to QC analysts for enhancing Good Documentation Practices within cGMP frameworks and applicable SOPs.
• Complete assigned tasks within established timeframes while managing organizational responsibilities including tracking open tasks and timelines.
• Support the development and review of QA events, deviations, and investigations as required.
• Maintain effective communication with QC Analysts, Group Leaders, and departmental managers to ensure seamless operations and quality compliance.

Who This Role Is For

• You can effectively communicate issues and ideas with direct reports, peers, and with management.
• You have a strong ability to achieve thoroughness and accuracy when performing tasks.
• You have strong prioritization / organizational skills and are detailed-oriented.
• You have the capability to adjust to shifting priorities, manage multiple tasks and meet deadlines.
• You have excellent written and oral communication skills.
• You have experience in a GMP setting.

Education and Experience

To be considered for this position you must have a BS/BA in a scientific field, or equivalent combination of education and experience.

Specialist: Requires a BS/BA in a scientific field and 2 years of related experience or equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

Benefits

• 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.
• Family support benefits.

Compensation

Salary Range (annually) $67,400.00 - $110,000.00

Company Culture

We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

If you have any questions, please speak with your recruiter.

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.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where 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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.