Quality Control Specialist

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health and wellness programs

Stock for employees

Fitness centers

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC Specialist for the 1st shift (Mon-Fri, 8:00am–4:30pm) to support QC External Testing with data review of analytical results from Advanced Therapies.

You will review Release, In-Process, and Stability data, verify documentation for method qualification, transfer and validation, and ensure compliance with cGMP, GDP, FDA/EMA/ICH guidelines and ALCOA+ principles. Strong attention to detail and teamwork are essential.

Qualifications

• Bachelor's degree in a scientific field or equivalent experience.
• 2 years of related experience in a GMP/GxP environment preferred.
• Experience performing data review of analytical results and documentation.

Responsibilities

• Review Release, In-Process, and Stability data in Advanced Therapies.
• Evaluate analytical method qualification, verification, transfer, and validation docs.
• Ensure data compliance with cGMP, GDP, FDA/EMA/ICH guidelines.
• Verify data per ALCOA+ principles.
• Monitor adherence to laboratory procedures and approved protocols.
• Collaborate with lab personnel to address documentation errors.
• Provide guidance to QC analysts on Good Documentation Practices.

Skills

Data review

cGMP compliance

ALCOA+

Analytical methods

Communication

Attention to detail

GMP experience

Education

BS/BA in a scientific field

Job description

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.

This role might be for you if:

• 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

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.

Does this sound like you?

• 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.

We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.

Please contact us to discuss any accommodations you think you may need.

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 r