We are looking for an R&D Specialist to join the Quality Control team. Quality Control supports the Bioanalytical Sciences, Protein Biochemistry, Analytical Chemistry and Pharmacometrics groups at Regeneron.
In this role, a typical day may include:
Performing an independent quality and timely review of documentation for accuracy and consistency to ensure compliance in accordance with regulations, established procedures and protocols.
Routinely reviewing multiple documents within the same day, while multi-tasking across assignments and shifting gears to meet changing priorities and/or provide cross functional support, as needed.
Assembling all available resources to perform an independent documentation review, evaluating the quality of the documentation using QC knowledge/skills, and following appropriate approaches or techniques to resolve findings.
Identifying and troubleshooting complex problems and contributing to process improvement initiatives.
Utilizing applicable software systems (e.g. LIMS, ELN, SoftMax, etc.) for a quality data review.
Coordinating quality control activities under supervision and assisting with training others, as needed.
Actively participating in sub-group and/or department meetings and sharing work with others.
Collaborating with and engaging customers to improve documentation quality.
This role may be for you if you:
Proactively ask questions to aid in the understanding of the work and are capable of identifying solutions for routine and complex problems and contributing to process improvement initiatives.
Communicate effectively, take in information through strong listening skills and share information in a clear and transparent manner.
Are a strong collaborator that exhibits professionalism and integrity while engaging customers.
Possess self-knowledge, have a strong sense of accountability related to assigned work, and are willing to participate in your own professional and personal development.
To be considered for this role, you must have a minimum of a Bachelor’s degree and 4 plus years of relevant experience. Strong interpersonal and organization skills are required. Computer proficiency including, Word documents, Excel spreadsheets and databases is vital. Knowledge and experience of immunoassays, protein biochemistry and/or analytical chemistry in a regulated environment is preferred. Experience with analytical procedures such as ELISA, chromatography (HPLC, FPLC), electrophoresis (SDS-PAGE, CE, Westerns, IEE), Mass Spectrometry, etc. and software such as Electronic Notebooks (ELN) or Laboratory Information Management System (LIMS) a plus.