In this role you will perform a wide variety of duties to support chain of custody for raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
As a QC Analyst in the Sample Management department a typical day might include but is not limited to, the following:
- Oversees and maintains appropriate procedures to ensure chain of custody for QC samples is maintained.
- Ensures a high level of customer service for teams submitting samples for QC, including customer queries.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
- Participates in training of other new employees and prioritizes workloads every day.
- Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiates and completes CAPAs and Change Controls in accordance with site procedures.
- Writes new and updates current SOPs as needed.
- Presents analytical data reports clearly and concisely to management.
- Performs other duties relevant to the QC laboratory position as required.
To be considered for this opportunity you must hold a third level qualification in a scientific/technical discipline. Previous experience working in a regulated QC Laboratory testing environment would be a distinct advantage. Experience with electronic systems such as LIMS, Empower. SoftMax, Qumas, eDoc, Trackwise etc is an advantage.
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.