Associate QA Validation Specialist

Regeneron; United States; On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron seeks a QA Validation Specialist to validate equipment, systems, and processes in line with regulatory requirements and internal standards. The role supports manufacturing quality and ensures adherence to SOPs and acceptance criteria.

The position involves drafting and reviewing validation protocols, data packages, and reports; analyzing results; and coordinating with multiple departments and external contractors to complete validation tasks. Travel may be required.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences required.
• Regulatory knowledge or experience in QA/validation preferred.
• Experience in generating qualification/validation protocols.
• Ability to coordinate with multiple departments and vendors.

Responsibilities

• Generate, implement and/or review master and completed qualification and validation protocols and reports for regulatory conformance.
• Analyze testing results against pre-determined criteria for acceptability.
• Investigate and troubleshoot problems and recommend changes/improvements.
• Review, edit and approve deviation notifications, investigations, CAPAs, change controls, SOPs and reports.
• Coordinate validation tasks with other departments or outside contractors/vendors.
• May supervise staff to meet goals and deadlines.
• Prepare status reports and manage projects.
• May present at internal and external audits (regulatory).
• Perform additional duties as assigned by management.
• Some travel may be required.

Skills

Independence

Teamwork

Communication

Time management

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

Microsoft Office

Job description

Job Description

The QA Validation department is hiring! The QA Validation Specialist - validates and qualifies equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

As a QA Validation Specialist, a typical day might include the following:

• Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

• Reviews, edits and approves deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation

• Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.

• Manages projects and prepares status reports.

• May present at both internal and external (regulatory) audits

• Other duties assigned by management.

• Some travel may be required.

This role may be for you if you:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate supportive behavior at all times

• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

• Gathers and organizes information

• Meets commitments on time

• Performs well-defined tasks

• Effective time management skills

• Seeks to identify continuous improvement needs

In order to be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and

• 0 – 2 years of relevant experience for an Associate

• 2+ years of relevant experience for a Specialist

• 5+ years of relevant experience for a Senior Specialist

• 8+ years of relevant experience for a Principal Specialist

• May substitute proven experience for education requirement

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 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.

Salary Range (annually)

$62,355.00 - $92,400.00