QC Analyst II - Raw Materials
QC Analyst II, Raw Materials
Our growing bio-pharmaceutical company is looking for a QC Analyst II, Raw Materials to be part of the team. We strongly believe in the power of positive culture as an essential key for individual and business success. For the last 4 years running we're so proud to continuously win a spot on the Boston Globe's "Top Places to Work" Our ideal QC Analyst II, Raw Materials candidate will be responsible for routine testing of incoming raw materials and product (in-process, samples, release, etc.) in support of GMP manufacturing.
- Experience with compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (HPLC,GC,FTIR, KF, etc.)
- Perform QC raw material, in-process, and bulk drug product testing, as well as support of testing and review of data with and from contract testing laboratories (e.g. compendial methods, HPLC, fluorescence assays, particle sizing, bioburden, and endotoxin, etc)
- Participate in method transfer to and from contract laboratories
- Perform data
- Author SOPs with guidance, as needed
- Troubleshoot routine problems that are related to laboratory procedures, assay performance, instrumentation, and data with input from direct manager; provide recommendations to non-routine issues.
- Bachelors in science related field
- At least 2 years' experience in a GMP laboratory setting
- Experience with compendia (USP, Ph. EUR, and JP)
- Experience performing compendial assays, wet chemistry techniques, HPLC/UPLC, GC, Karl Fisher, UV-Vis and FTIR; microbiological methodology understanding is highly desirable
- Experience with aseptic techniques and gowning is highly desirable
- Experience with data trending and control chart interpretation is desirable
- Make certain compliant laboratory function and continuous state of inspection readiness
- Make certain production support within cycle times to meet on-time delivery of OnPattro to patients
If you or someone you know in your network is interested in this position, then please send an updated resume to the attention of N.Silvera (AT SIGN) realstaffing.com and her team at Real Staffing Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.