| Quality Control Analyst (Clinical) !! Boston, MA (Must be local) at Boston, Massachusetts, USA |
| Email: [email protected] |
| From: Jitendra, Tekpyramids [email protected] Reply to: [email protected] Title :: Quality Control Analyst ( Clinical ) Location :: Boston, MA (Must be local) Duration :: 6+ Months MOI :: Video Visa :: NO H1B Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing. Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected. Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives. Testing execution, participate in training analysts, trouble shooting of methods QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records) Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support Bachelors degree and a minimum of 5+ years of related experience. (science related degree is preferred) Previous experience in a GMP QC role MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding Best Regards , Jitendra Singh Technical Recruiter Email : jitendra.s @tekpyramids.com 24175 Northwestern Hwy, Suite 120, Southfield, MI 48075 Click here to view our latest jobs This electronic mail (including any attachments) may contain information that is privileged, confidential, and/or otherwise protected from disclosure to anyone other than its intended recipient(s). Any dissemination or use of this electronic mail or its contents (including any attachments) by persons other than the intended recipient(s) is strictly prohibited. If you have received this message in error, please notify us immediately by reply e-mail so that we may correct our internal records. Please then delete the original message (including any attachments) in its entirety. Thank you. Keywords: microsoft Massachusetts Michigan Quality Control Analyst (Clinical) !! Boston, MA (Must be local) [email protected] |
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| Mon Aug 05 20:42:00 UTC 2024 |