Product data entry analyst/ sample handling support

Product Data Entry Analyst/ Sample Handling Support

Our client is looking for Product data entry analyst/ sample handling support- with good Clinical Practices, Data entry, LIMS, GMP, Data transcription / verification, and LIMS sample review experience etc.

RESPONSIBILITIES:

Data transcription, review, and trending of biologics (mAb, antibody drug conjugate, etc) stability data in preparation for regulatory filings.

Specifically, the analyst will be expected to: Retrieve data from LIMS (Laboratory Information Management System) database or other data repository.

Transcribe data into stability sections of regulatory filings, or perform 100% accuracy verification for previously transcribed data; Review sample results within LIMS to identify incomplete testing

Notify Stability Lead of any unusual findings or gaps in data; Assist Stability Leads with various tasks as necessary

Assist with sample handling duties as needed (shipment receipt, aliquoting, etc.)

QUALIFICATIONS AND SKILLS NEEDED:

Background in biochemistry, biology, chemistry, or related scientific discipline; Understanding of normal pharmaceutical development processes

Ability to work in a highly regulated environment and learn/comply with GMP expectations; Ability to accurately transcribe data from Excel documents to MS Word; Ability to thrive in a fast-paced environment and adapt to changing priorities; Familiar with Microsoft Office Suite, and computer literate enough to quickly learn new systems.