Stellenbeschreibung
Quality Control External Testing is currently looking to fill a Staff QC Lab Operations Specialist position with a 1st shift, Monday-Friday, 8:00am – 4:30pm schedule. This position performs data review of analytical test results to support QC External Testing operations. In this role, a typical day might include the following:
Provide oversight, lead, and manage the data review function within QC External Testing, establishing priorities and workflow processes to maximize efficiency and quality outcomes.
Conduct comprehensive data review for Release, In-Process, and Stability testing in Advanced Therapies, ensuring adherence to quality standards.
Perform thorough evaluation of analytical test method Qualification, Verification, Transfer, and Validation documentation.
Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through meticulous review processes.
Verify analytical data meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
Monitor testing compliance with established laboratory procedures, test methods, and approved protocols.
Collaborate with laboratory personnel to address documentation errors and omissions while fostering a cGMP-oriented culture.
Demonstrate exceptional attention to detail, focus, and multitasking capabilities when reviewing complex analytical laboratory data.
Apply strong technical expertise in various analytical methodologies including liquid chromatography, pH measurement, iCIEF, ELISA, SEC, and CE-SDS.
Engage with team members to implement continuous improvements to data review processes and methodologies.
Provide strategic guidance to QC analysts for enhancing Good Documentation Practices within cGMP frameworks and applicable SOPs.
Complete assigned tasks within established timeframes while managing organizational responsibilities including tracking open tasks and timelines.
Support the development and review of QA events, deviations, and investigations as required.
Maintain effective communication with QC Analysts, Group Leaders, and departmental managers to ensure seamless operations and quality compliance.
This role might be for you if:
You have management / supervisory experience.
You can effectively communicate issues and ideas with direct reports, peers, and with management
You have a strong ability to achieve thoroughness and accuracy when performing tasks
You have strong prioritization / organizational skills and are detailed-oriented.
You have the capability to adjust to shifting priorities, manage multiple tasks and meet deadlines
You have excellent written and oral communication skills
You have experience in a GMP setting
To be considered for this role, you must have a BS/BA in a scientific field or equivalent combination of education and experience.
Staff Specialist: Requires a BS/BA in a scientific field and 10 years of related experience or equivalent combination of education and experience.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.
Salary Range (annually)