Limerick, Ireland
28 days ago
QC Analyst (Compliance)

As a QC Compliance Analyst you will support the QC organization in meeting compliance targets through laboratory investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs.

A typical day might include, but is not limited to, the following: 

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 proceduresReporting quality system metrics to the group and other QC functionsConducting cross functional laboratory investigations that may span the entire QC department and coordination of resources from multiple departmentsRepresenting QC on interdepartmental teams and in meetingsStriving for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectationsParticipating in regulatory inspections as requiredCompleting other tasks as directed by Manager

Additional responsibilities for Analysts may include, but are not limited to:

Increasing involvement in the training of employeesIncreasing responsibilities for authoring and reviewing documents/ dataCompliance representation and participation in cross functional site meetingsTechnical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.

To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent with relevant experience, preferably in the pharmaceutical or biotechnology industries. 

#LI-Onsite #REGNQC #REGNIEEC #IRELIM

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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