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.
Pooja Mishra
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
Tel: 732 429 1636
(W) 732-549-2030 x 214 | (F) 732-549-5549
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.