Quality Engineer Job at Katalyst Healthcares & Life Sciences, Boston, MA

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  • Katalyst Healthcares & Life Sciences
  • Boston, MA

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Responsibilities :

  • Develop, implement, and maintain quality systems and procedures in compliance with FDA, EMA, and cGMP regulations.
  • Support deviation investigations, CAPAs, and change control activities.
  • Review and approve manufacturing and quality documentation including SOPs, batch records, and protocols.
  • Participate in internal audits, risk assessments, and inspection readiness efforts
  • Collaborate with cross-functional teams (QA, QC, Manufacturing, Validation, Engineering) to ensure product quality and compliance.
  • Lead continuous improvement initiatives for quality system enhancement.

Requirements:

  • 8+ years of quality engineering experience in pharma or biotech.
  • Strong understanding of FDA regulations, ICH Q8-Q10, and cGMP standards.
  • Hands-on experience with CAPA, deviation management, and quality documentation.
  • Excellent written and verbal communication skills.
  • Strong problem-solving and analytical mindset.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

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