Principal Quality Control Lab Operations Specialist

We are currently looking to fill a Principal QC Lab Operations Specialist with a Monday-Friday 8-4:30pm schedule. As a Principal QC Lab Operations Specialist, subject matter expert, and leader in the laboratory, support Quality Control (QC) departments through project management, technical support, and compliance related activities.

As a Principal QC Lab Operations Specialist, a typical day might include the following:

• Serves as primary point of contact for QC on cross-functional teams to facilitate the advancement of projects: 
  • Organizing meetings and creating agendas, minutes and handling action items.
  • Gathering / compiling data and project information.
  • Tracking project deliverables through management of tools, e.g. dashboards, Smartsheet, MS Project, etc.
  • Ensuring effective communication of project deliverables up and across the QC.
  • Projects may include, but are not limited to, automation, new technology or assays, and transfer activities
  • Identifying and executing process improvements across QC functions while maintaining GxP compliance.
  • Executing and/or coordinating the completion of lab operations activities
  • Ensuring timely completion of activities impacting lab operations
  • Training and educating group members on processes
  • Collaborating with internal and external teams to harmonize operations and ensure consistency within quality control laboratories.
  • Ensuring QC laboratories and operations are in compliance with regulatory expectations
  • Acting as primary point of contact for inspection related activities
  • Acting as subject matter expert and provides technical support as needed
  • Identifying, leading, and solving technical problems within QC

This role might be for you if you have experience in:

• Statistical analysis;
• Extensive knowledge of cGMP;
• Extensive knowledge of HPLC's and Empower
• Ability to work independently or part of a cross-functional team;
• Interpersonal, oral, presentation, and written scientific as well as business communication skills;
• Word processing, spreadsheet, database management, graphing, and presentation software

To be considered for the Principal QC Lab Operations Specialist you must be willing and able to work Monday-Friday 8-4:30pm. You must have a BS with 8 years experience or equivalent combination of education and experience, may consider another degree discipline or position level with commensurate experience; cGMP experience is required.

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.

Salary Range (annually)

$86,900.00 - $141,900.00