Job Description
We are currently looking to fill a Compliance Specialist – Technical Operations position. This position performs all compliance-related tasks necessary to complete investigations and implementation of robust corrective actions for supporting manufacturing and site operations. This position provides compliance expertise throughout the Engineering, Automation & Facilities departments.
In this role, a typical day might include the following:
Independently leads non-conformance investigations to prevent reoccurrences.
Reviews Equipment Drawings, Schematics, Life Cycle Documents, and Automation programming
Reviews SOPs, Work Instructions, Batch Sheets, Manufacturing Records and Logbooks in accordance with cGMP standards.
Monitoring production processes to obtain necessary data in support of investigations and track effectiveness of changes.
Collects, trends, and analyzes process related data to evaluate the non-comformance.
Leads/Performs Root Cause Analysis on Medium/High risk non-conformances
Identify and evaluate the severity of the non-conformance, potential product impact and Corrective/Preventative actions
Coordinates, participates, and/or leads cross-functional team meetings.
Prepares investigation reports that include event details, root cause analysis, product impact assessment, and Corrective Action recommendations for medium/high severity non-conformances.
Maintains and documents all training in accordance with cGMP standards.
May revise controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
May train and mentor new employees on investigatial processes and techniques.
May assist in regulatory inspection preparations, act as a department liaison during regulatory inspections, and coordinate post-inspection activities.
This role may be for you if you:
Have advanced knowledge of cGMP operations, regulatory, quality requirements, root cause analysis and risk evaluation.
Possess strong written and verbal communication skills.
Have working knowledge of equipment specification requirements.
Are able to work with minimal supervision/guidance.
Can review and understand engineering drawings.
To be considered for this role you must hold a Bachelor’s degree in life sciences, engineering or a related field and the following minimum amounts of related experience:
Associate 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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)