QA Specialist (Deviation Investigation)

Rensselaer, NY, United States
Nov 19, 2020
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Quality Assurance Specialist (Deviations) position. This position functions to provide day-to-day QA support and ensure quality systems are executed appropriately according to current requirements. This role will serve as the QA point-of-contact for their assigned operational area and will be primarily responsible for approving deviation investigation records, assigning CAPAs, and performing documentation review.
In this role, a typical day might include the following:
• Deviation investigation review and approval
• Collaborating and deciding appropriate CAPAs to mitigate root cause, CAPA record allocation/assignment for QA review
• Facilitating and/or coordinating daily deviation review meeting
• Monitoring record activity and due dates, meet schedules and due dates
• Supporting regulatory and customer audits
This role may be for you if you:
• Excel in a quality driven organization
• Possess a broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
• Are experienced with documentation and quality systems
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor's degree 2+ years of relevant experience for Associate level, 4+ years for Specialist level, 6+ years for Senior level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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.