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QC Analyst

Company: Planet Pharma
Location: Somerville
Posted on: January 16, 2022

Job Description:

Job Summary/Operations Involvement: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.Discretion/Latitude: Work is performed under general direction with general supervision. Work may be reviewed upon completion for adequacy in meeting objectivesImpact:Contributes to the completion of organizational projects and goals. Errors in judgement or failure to achieve results would normally require a moderate expenditure of resources to rectify.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 stabilityReview QC analytical assaysExecute and lead method qualification and validation assays as neededPerform and lead OOT, OOS, GMP Investigations, data analysis, deviation and data trendingMaintain GMP condition of the labJob ScopeReceives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with established policies. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which effect subordinate organizations.% of Time Job Function and description 40-50% Testing execution, participate in training analysts, trouble shooting of methods 30-40% 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) 10-20% Participate in training analysts, troubleshooting of test methods including involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory supportEducation and Experience:Typically requires a bachelors degree and a minimum of 2+ years of related experience. (science related degree is preferred)Excellent communication, interpersonal and organizational skills.Ability to work well both independently and in a team environment.Ability to prioritize work and multitask.Previous experience in a GMP QC role is preferred. 5S/OE experience. Method transfers/validation

Keywords: Planet Pharma, Somerville , QC Analyst, Professions , Somerville, Massachusetts

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