Associate QA Validation Specialist

Regulatory Jobs; City of Rensselaer (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron is seeking an Associate QA Validation Specialist to validate equipment, systems, and processes per regulatory standards in the cleaning validation team. The role emphasizes protocol development, data review, and cross-functional coordination on-site in the United States.

The candidate should have a BS/BA in Engineering, Chemistry, or Life Sciences with 0–2 years of experience for Associate and opportunities for progression.

Qualifications

• BS/BA in Engineering, Chemistry or Life Sciences.
• 0–2 years for Associate; 2+ for Specialist; 5+ for Senior Specialist; 8+ for Principal Specialist.
• Substitution of proven experience for education may apply.
• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint).

Responsibilities

• Generates, implements and/or reviews qualification/validation protocols and summaries.
• Analyzes testing results against acceptance criteria.
• Investigates problems and recommends changes or improvements.
• Reviews/edits deviation notifications, investigations, CAPAs, SOPs and reports.
• Coordinates with departments or contractors to complete validation tasks.
• May supervise/assign work to validation staff.
• Manages projects and prepares status reports.
• May present at internal and regulatory audits.
• Other duties as assigned; some travel may be required.

Skills

Integrity

Independence

Communication

Process improvement

Time management

Attention to detail

Education

BS/BA in Engineering

BS/BA in Chemistry

BS/BA in Life Sciences

Tools

Microsoft Office

Job description

The Associate 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. This position is for the cleaning Validation team.

As an Associate 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.

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