Quality Assurance Associate III

3 weeks ago

Waltham, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Person in Plant for Manufacturing runs.
  • Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
  • 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
  • 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
  • ssist with internal and external audits.
  • Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
  • ssume additional responsibilities as assigned.
Requirements:
  • Bachelor's and/or 8+ years of relevant experience
  • Minimum 5 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.
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
  • Excellent communications skills both written and verbal.
  • Effective time management and organizational skills.
  • Strong attention to details and ability to lead others in a team setting.
  • bility to gown and enter clean rooms
  • Perform review of Batch records and associated documents in support of the release of a product.
  • Review of Analytical data
  • Perform QA presence on the floor/person in the plant
  • Ensure that documentation and operations meet established requirements of cGMPs, Internal
  • SOPs, and company policies.
  • Draft and revise procedures as required.
  • Performs work that requires decision-making and the consistent exercise of independent judgment and discretion

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