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Quality Assurance Investigators

2 months ago

Baltimore, Maryland, United States Vakulatech Full time
Job Overview

Position: Deviation Investigators

Location: Baltimore MD (100% on-site)

Compensation: $20-$25 per hour

Project Duration: 6 months+

Key Qualifications:
  • Bachelor's degree in chemical, biomedical, or biochemical engineering, biological sciences, or a related discipline.
  • Minimum of 1 year of pertinent industry experience in a cGMP setting.
  • Familiarity with cGMP manufacturing practices and regulatory standards applicable to biotechnology, pharmaceuticals, and medical devices.
  • Experience in quality assurance responsibilities and remediation processes.
  • Proficient in reviewing Master Batch Records and validation documentation.
  • Skilled in documenting remediation efforts.
Job Responsibilities:
  • Conduct thorough reviews of all project and system deliverables, including but not limited to Master Batch Records, plans, requirements, specifications, test protocols, scripts, summary reports, and change controls.
  • Evaluate system operational and administrative procedures to ensure compliance and adequacy.
  • Document any instances of non-compliance identified during reviews.
  • Support strategic planning for remediation activities.
  • Record all remediation efforts comprehensively.
  • Assist in the evaluation of remediation processes.
  • Perform additional duties as assigned.