As a Compliance Analyst you will support the QC organization in meeting compliance targets through laboratory investigation and deviation management. Reports quality system metrics to the group and identifies improvements that can be made in all quality system inputs.
Essential Duties and Responsibilities include, but are not limited to, the following:
Responsible for authoring and peer review of failure investigations/ deviations relating to QC operations including:
- NOE, EOE and DNF
- GLIF investigations
- Corrective and preventive actions
- Change control
- Standard operating procedures
- Report quality system metrics to the group and other QC functions.
- Conduct cross functional laboratory investigations that may span the entire QC department and coordination of resources from multiple departments.
- Represent QC on interdepartmental teams and in meetings.
- Strive for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations.
- Participate in regulatory inspections as required.
- Complete other tasks as directed by Manager.
Additional responsibilities for Analysts may include, but are not limited to:
- Increasing involvement in the training of employees.
- Increasing responsibilities for authoring and reviewing documents/ data.
- Compliance representation and participation in cross functional site meetings.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Education and Experience:
Requires BS/BA in Life Sciences or equivalent along with relative experience for levels beyond I, preferably in the pharmaceutical or biotechnology industries.
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.