Quality Assurance Specialist

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.