Quality Control Data Reviewer

Regeneron Pharmaceuticals, Inc (USA); United States; Sur place; USD 34 000 - 53 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a QC Data Reviewer to perform data review supporting release, stability programs, and lab operations within Quality Control. The role follows regulatory guidelines to drive performance and operates on a Tuesday–Saturday 8am–4:30pm schedule.

You will review analytical test results for compliance, support stability reporting, and maintain SOPs related to data review. A BS/BA in Chemistry, Biology, or related field is required.

Qualifications

• BS/BA in Chemistry, Biology, or related field.
• Willing and able to work Tuesday– Saturday, 8am–4:30pm.
• Level will be determined by demonstrated experience.

Responsabilités

• Execute detailed data review for analytical test results for cGMP compliance, internal SOPs and Specifications.
• Support production, stability studies, and lab operations.
• Review release and stability data, trend charts of reference standards, calibration records and logbooks.
• Perform detailed data review for analytical test results from contract testing labs to ensure accuracy.

Connaissances

Data review

Regulatory guidelines

Data analysis

Communication

Formation

BS/BA in Chemistry, Biology, or related field

Description du poste

Job Overview

Regeneron is looking for a QC Data Reviewer to perform data review to support release, stability programs, and lab operation within Quality Control. This role continuously strives to follow all pertinent regulatory agency guidelines to drive performance. This position is a Tuesday– Saturday 8am-4:30pm schedule.

Typical Day

As the QC Data Reviewer, a typical day might include the following:

• Executing detailed data review for analytical test results generated by QC for compliance with cGMP, internal SOPs and Specifications
• Supporting production, stability studies, and lab operations
• Reviewing release and stability data, trend charts of reference standards, lab equipment calibration records and logbooks
• Performing detailed data review for analytical test results created by contract testing labs to assure correctness and accuracy
• Maintaining and updating relevant SOPs for data review and reporting
• Collaborating with Stability and other groups to support stability report writing and regulatory updates
• Participating in all vital training activities

Role Fit

This role might be for you if:

• You have a solid understanding of data reviewing and regulatory agency guidelines
• You are results-oriented and can optimally analyze data trends
• You can work efficiently as an individual as well as with others
• You are a strong communicator who is willing to build beneficial relationships with other peer groups

To be considered for this role, you must have a BS/BA in Chemistry, Biology, or related field. You must be willing and able to work Tuesday– Saturday 8am-4:30pm. Level will be determined by demonstrated experience.

Salary Range (hourly)

$24.76 - $38.70

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

Background Checks

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.

Location

For jobs in Canada: this posting is for an existing position.

Equal Opportunity

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.

Company

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.

Additional Information

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