DATA ANALYST DEVENS, MA Hybrid role: 50 remote / 50 onsite.
Required Skills:
Minimum BS degree with 2+ years relevant life-science industry experience (pharmaceutical/biologics) preferably in a QC environment.
Knowledge of biologics laboratory settings, GMPs, and support disciplines and the basic principles of each.
Knowledge and understanding of regulatory and technical data trending requirements and associated processes.
Strong understanding/knowledge of Aegis (Discoverant), SAP, Sample Manager, LES, Empower and Infinity preferred.
Ability to work collaboratively with all employees at all levels.
Proficiency in Windows XP, Windows Server 2000, Windows 2003 Server, Oracle, SQL Server.
Ability to perform well in a team-based environment.
Job Description:
To support QC methods and instrument performance by monitoring and analyzing invalid rates, using statistical tools, to monitor variation of reference standard data and critical reagents allowing for reaction to adverse trends within the QC Labs ensuring consistent performance.
Monitor and analyze analytical method performance using statistical tools.
Provide support during PMI/LES application maintenance related activities.
Support data/analysis requests for APR/APQR, investigations, and analytical method changes within PMI and LES applications.
Support optimization and improvements of analytical method performance data assessments and trending.
Support investigations related to release and method performance (OOT).
Support data mining, collection, and verification to support local trending and network initiatives.
Support writing of technical reports, APQR, SAE Checklists and MPSAE Checklists.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Purvi: purvi@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00535
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
