drjobs Quality Engineer

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1 Vacancy
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Job Location drjobs

Boston - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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.


Remote Work :

No


Employment Type :

Contract

Employment Type

Contract

Company Industry

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