Temp QC Compliance Analyst Job Description
This role supports the QC organisation in meeting compliance targets through laboratory investigation and deviation management.
Main Responsibilities:
* Authoring and peer reviewing of failure investigations/deviations relating to QC operations, including NOE, EOE, and DNFA, GLIF investigation, corrective and preventive actions, change control, and standard operating procedures.
* Representing QC on interdepartmental teams and in meetings.
* Striving for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations.
* Participating in regulatory inspections as required.
Additional Responsibilities:
* 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.
Requirements:
* BS/BA in Life Sciences or equivalent with relevant experience, preferably in the pharmaceutical or biotechnology industries.
Regeneron Values:
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.