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Quality Assurance Associate II (Scientific)

Katalyst HealthCares & Life Sciences
South Waltham, MA
Closing date
May 29, 2023

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Science, Pharmaceutical, Quality Assurance
Organization Type
Job Description


  • Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
  • Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
  • SME for Quality in vendor meetings for raw materials, excipients, cell banks and plasmids
  • Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
  • Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
  • Issue/Review documentation, i.e., Deviations, CAPAs, OOS etc., as they occur.
  • Write and revise SOP, forms, WI, and any other document types
  • Assist with internal and external audits.
  • Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
  • Assume additional responsibilities as assigned.
  • Bachelor's degree and/or 10+ years of relevant experience; Masters preferred
  • Minimum 8 years of experience in Quality Assurance
  • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
  • Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
  • Preferred experience with outsourced manufacturing and testing operations
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

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