QA Specialist- Validation (Cambridge, MA) at Regeneron Pharmaceuticals, Inc.

We are seeking a Quality Assurance Specialist to join our Quality Operations Team. In this role, you will support the lifecycle of GxP equipment, instruments, computer systems, facilities, and IT infrastructure critical to both internal and external operations. You will collaborate with business partners (Quality Control, IT, MFG, Facilities, Quality Assurance, and others) to ensure a risk-based phase-appropriate model is used supporting our end users.

As a QA Specialist, a typical day might include:

• Providing QA support for validation activities including analytical instruments, enterprise and laboratory computer systems validation, facility, utility, systems, and equipment (FUSE) commissioning, qualification, use, and maintenance, etc.

• Investigating and approving validation Excursions/Deviations

• Providing guidance, review, and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), qualification protocols, data analysis, and final reports.

• Reviewing and approving of changes to validated systems, including operational computer systems, in support of change controls (including assessment of impact).

• Assessing implemented change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

• Reviewing, editing, and approving deviation notifications, deviation investigations, and corrective actions.

This role may be for you if you:

• Are a highly collaborative teammate who fosters open communication and facilitates mutual understanding and cooperation between all collaborators (internal and external)

• Have demonstrated leadership within teams producing results

• Have the ability to communicate effectively in a way that fosters positive relationship building

• Have a passion for addressing the critical unmet medical needs of patients

• Are self-directed individual who can work in a risk tolerant, fast-paced, innovative environment

In order to be considered for this role, you must have at least a BS/MS with 2+ years of relevant technical validation experience. Biopharmaceutical/industry experience in the cell and gene therapy space is strongly preferred. Must have extensive technical validation or QAV experience. We need someone with experience in an cGMP/GxP environment. Familiarity with validation and commissioning is preferred. Familiarity with Computer System regulations (21 CFR Part 11, Data Integrity) is also preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)