Within this role you will be supporting the QC Critical Materials, QC Reference Standards and Procurement of all categories of laboratory Chemicals and Components Quality Control at the Limerick Manufacturing.
As a QC Data Analyst a typical day might include, but is not limited to, the following:
Compiling internally and externally generated data in support of compiling Cof As and Sof As
Preparing and providing Cof As and Sof As for all lot release materials
Working with members of manufacturing, QA, RA, and R/D to provide updates/status of Cof As, Sof As, testing issues, etc.
Trending QC product release data to support lot release and regulatory filings
Acting as a liaison between QC, Process Analytical Sciences, and Manufacturing group to provide trending analyses to support various activities such as manufacturing investigations, and validation studies
Assisting in the implementation and maintenance of product release data trending program for each product candidate
Presenting trending data at the in-depth product review
Writing product annual release data trending reports
Writing lot specific data trending reports for each lot to be released
Preparing and populating matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
Compiling data to support QC department metrics and performance tracking
Assisting with the improvement effort of streamlining the review and release process
Attending meetings as required on behalf of Quality Control to update partners (Drug Supply, External Manufacturing, QA) as to status issues pertaining to release data
Attending meetings to keep informed of development and manufacturing priorities and activities
Ensuring compliance with applicable c GMP regulations and SOPs
Maintaining and updating relevant SOPs for data review and reporting as needed
Meeting specified timelines to support release and regulatory filings
Compiling with all pertinent regulatory agency requirements
Participating in required training activities
This role might be for you if:
You are a passionate and innovative problem-solver
You are team-oriented with strong communication skills
You are an adaptable continuous learner
To be considered for this opportunity you should have BS/BA in related field required with a minimum of 2 years of relevant experience or equivalent combination of education and experience in quality system delivery.
#LI-Onsite #REGNQC #JOBSIEST #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.