Principal QA Validation Specialist
We are looking to hire a Principal QA Validation Specialist to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
In this role, a typical day might nclude:
- Generates, executes 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.
- Collaborates with functional departments to resolve issues.
- Trains and mentors less experienced Specialists.
- May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
- Lead and drives projects and prepares status reports.
- May present at both internal and external (regulatory) audits
- Stays current with industry trends, regulatory requirement updates, and communicating same to team
- Some travel may be required.
- BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field required
- Equivalent combination of education and experience
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.