Randstad QC Analyst in Lexington, Massachusetts
salary:$35.23 - $41.45 per hour
date posted:Wednesday, May 19, 2021
industry:Professional, Scientific, and Technical Services
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location: Lexington, Massachusetts
job type: Contract
salary: $35.23 - 41.45 per hour
work hours: 9 to 5
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 in process, drug substance/product and various protocol studies using analytical test methods derived from non-compendial sources.
The position is expected to maintain operational and GMP readiness of the QC area. In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects.
Position is expected to act as a role model for junior staff in the various QC areas.
Specific HPLC Focus Areas:
Role is responsible for HPLC laboratories performing a broad range of analytical based techniques such as SE-HPLC, RP-HPLC, IEX, CE-SDS, glycan and peptide analyses 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.
Specific QC Focus Area:
Product testing: Areas of focus on techniques such as HPLC and SDS-PAGE for purity, identity, potency and charged heterogeneity.
Perform and troubleshoot HPLC based assays (SE-HPLC, IEX, RP-HPLC, CE-SDS, Peptide Mapping, and Glycan Mapping) of release and stability
Review QC analytical assays
Execute and lead method qualification and validation assays as needed
Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation and data trending
Maintain GMP condition of the lab
Typically requires a bachelor's degree and a minimum of 2+ years of related experience. (science related degree is preferred)
skills: HPLC, Assay Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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