We are currently looking to fill a QA Validation Specialist (Compliance) position. This position will be part of the QA Validation Compliance team, being responsible for the realization of industry standard methodologies while remaining adaptable to the changing needs of the company. Be part of a dynamic team in a fast-paced environment and work closely with multiple teams.
In this role, a typical day might include the following:
- Support tracking, reporting and driving closure of Quality Records (e.g. NOE-Notice of Event, CC - change controls, CAPA - corrective action preventative action)
- Mentor quality record owners and complete compliance review where applicable to ensure quality records are submitted RFT (Right First Time)
- Manage the Audit Ready 365 program and work with the teams to plan, coordinate and supervise coaching sessions
- Support internal and regulatory audits coordinating requests for the team
- Drive quality and compliance in our Validation activities by aligning practices as they relate to Compliance, Audit Readiness and Training for QA Validation
- Collaboratively identify improvements across both sites
- Develop processes and systems that drive compliance to critical regulatory requirements
- Development and deployment of Validation specific training
- Influence the development and revision of local and global policies, standards, procedures and business processes in alignment with industry standards for Validation
- Ensures that all quality-based results are aligning with regulatory and quality policies and procedures and timelines are met and observations are corrected
This role may be for you if you:
- Excel in a quality driven organization
- Have an understanding of cGMP systems and processes with a particular emphasis on compliance (strongly preferred)
- 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 in Engineering, Chemistry, or Life Sciences and the following minimum amounts of relevant experience for each level:
- Assoc Specialist - 0-2+ years
- Specialist - 2+ years
- Senior Specialist - 5+ years
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.