Job Description

Position: Quality Assurance Specialist
Locations: Harmans, MD OR Boston, MA

Job Summary:
We are looking for a QA Batch Record Review Consultant with extensive quality assurance experience in the pharmaceutical and biotech sectors. The consultant will ensure batch records comply with regulatory standards and industry practices, supporting high-quality product production. This detail-oriented role requires strong knowledge of Good Manufacturing Practices (GMP) and collaboration with cross-functional teams.

Key Responsibilities:

• Batch Record Review:

  • Review batch records for completeness, accuracy, and compliance with GMP and regulatory standards.
  • Document, investigate, and resolve discrepancies and deviations before batch release.
  • Collaborate with various departments to ensure quality compliance.
  • Recommend improvements for batch record documentation processes.

• Quality Assurance Support:

  • Assist in developing quality assurance processes for improved batch record accuracy.
  • Support internal audits and regulatory inspections by providing documentation and responses.
  • Participate in risk assessments and CAPA related to batch record discrepancies.

• Training and Development:

  • Train manufacturing and quality teams on batch record best practices.
  • Create and maintain training materials for batch record review processes.

Qualifications:

• Bachelor's degree in a related field (Chemistry, Biology, Pharmacy, Engineering); advanced degree preferred.
• Minimum of 3+ years of QA experience focused on batch record review in the pharmaceutical or biotech industries.
• Strong knowledge of GMP, FDA, and EMA regulations.
• Excellent attention to detail, analytical, and problem-solving skills.
• Ability to work independently and collaboratively, with strong communication skills.
• Experience with electronic batch records (EBR) systems is a plus.

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