QC Data Analyst

Regulatory Jobs; City of Rensselaer (NY); Presencial; USD 30.000 - 47.000; Jornada completa

Descripción de la vacante

Regeneron in Rensselaer, NY, is seeking an Associate QC Data Analyst to join the Quality Control team. You will compile, trend and report product release data, prepare CofAs and SofAs, and support lot release and regulatory filings while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences.

You will build tracking matrices and QC metrics, maintain SOPs and ensure cGMP compliance, meeting deadlines and contributing to investigations and validation studies.

Formación

• BS/BA in Chemistry, Biology or related field.
• Ability to comply with cGMP regulations and SOPs.
• Ability to meet timelines for lot release and regulatory filings.
• Willingness to participate in required training activities.
• Experience in a cGMP pharmaceutical QC laboratory is preferred.

Responsabilidades

• Compiles internal and external data to prepare CofAs and SofAs for all lot release materials
• Trends QC product release data to support lot release, regulatory filings and in-depth product reviews
• Writes annual product and lot-specific release data trending reports
• Partners with Manufacturing, QA, RA, R&D and Process Analytical Sciences to share status updates and trending analyses for investigations and validation studies
• Builds and maintains tracking matrices and QC metrics for release and stability testing and review status
• Supports the product release data trending program and improvements that streamline the review and release process
• Maintains and updates SOPs for data review and reporting while ensuring cGMP compliance
• Meets specified timelines and represents Quality Control in meetings with Drug Supply, External Manufacturing and QA

Conocimientos

Data analysis

Trend analysis

Data reporting

Educación

BS/BA in Chemistry or Biology

Descripción del empleo

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Associate QC Data Analyst to join our Quality Control team. In this role, you will compile, trend and report product release data, preparing Certificates and Summaries of Analysis and trending analyses that support lot release and regulatory filings, while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Rensselaer NY

• Work model/flexibility: On-site

Discover your role:

• Compiles internal and external data to prepare CofAs and SofAs for all lot release materials

• Trends QC product release data to support lot release, regulatory filings and in-depth product reviews

• Writes annual product and lot-specific release data trending reports

• Partners with Manufacturing, QA, RA, R&D and Process Analytical Sciences to share status updates and trending analyses for investigations and validation studies

• Builds and maintains tracking matrices and QC metrics for release and stability testing and review status

• Supports the product release data trending program and improvements that streamline the review and release process

• Maintains and updates SOPs for data review and reporting while ensuring cGMP compliance

• Meets specified timelines and represents Quality Control in meetings with Drug Supply, External Manufacturing and QA

This role requires:

• Education and experience: BS/BA in Chemistry, Biology or a related field, or an equivalent combination of education and experience

• Ability to comply with applicable cGMP regulations, SOPs and regulatory agency requirements

• Ability to meet specified timelines in support of lot release and regulatory filings

• Willingness to participate in required training activities

• Preferred/nice-to-have: Experience working in a cGMP pharmaceutical Quality Control laboratory

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/

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.

Salary Range (hourly)

$21.78 - $33.99