We are currently looking to fill a QC External Testing Coordinator position with a 1st shift, Monday-Friday, 8:00am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC External Testing Coordinators are responsible for supporting the daily operations of the QC External Testing group in accordance with Standard Operating Procedures (SOPs) and cGMP regulations. As a QC External Testing Coordinator, a typical day might include the following:
- Coordinating on-time shipment of samples to Contract Testing Labs.
- Coordinating receipt and entry of test data from Contract Testing Labs.
- Using a sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to determine accuracy and to maintain sample integrity.
- Coordinating the external laboratories and Regeneron subject matter experts (SMEs) in troubleshooting and identifying root cause analysis
- Providing technical advice as needed in support of invalid assays, deviations, OOS/OOT investigations.
- Reviewing and approving method transfer validation protocols and reports.
- Initiating and completing CAPAs and Change Controls in accordance with site procedures.
- Writing new SOPs and updating existing SOPs as needed.
- Initiating and managing workflows in the electronic document management system.
- Documenting and communicating discrepancies to appropriate personnel in a timely and efficient manner.
- Ensuring that all work performed is in compliance with the required regulatory standards (ex. cGMP), conforms to company policies and standard operating procedures (SOPs).
- Proactively identifying and implementing process improvements, lean initiatives.
- Performing other duties relevant to the position as required.
This role might be for you if:
- You have strong interpersonal skills and can effectively communicate issues and ideas with peers and with management
- You have excellent written and verbal communication skills
- You have a strong ability to achieve thoroughness and accuracy when performing tasks
- You have the capability to adjust to shifting priorities, manage multiple tasks and meet deadlines
- You have the capability to organize and maintain data or information
- You have effective time management skills
- You have a continuous drive to improve processes for improved performance
To be considered for the QC External Testing Coordinator position you must be willing and able to work 1st shift, Monday-Friday, 8:00am-4:30pm. In addition, there may be occasions when you may be required to be on call during off-hours (ex. weekends, holiday breaks) to support critical shipment or entry of results. BS/BA degree in biology, chemistry, microbiology or related field and 1 year of relevant work experience is required. 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 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.