Regulatory Compliance Specialist

15 hours ago


Reston, Virginia, United States I3 INFOTEK INC Full time
Job Summary:

The Quality Assurance Specialist will play a vital role in ensuring the compliance of manufacturing operations with regulatory and industry standards. This position involves on-floor oversight to guarantee that processes adhere to quality standards.

Main Responsibilities:

• Conduct real-time documentation reviews of batch records, cleaning logs, and other documentation during the manufacturing process.
• Collaborate closely with manufacturing and support teams to troubleshoot issues and facilitate smooth operations.
• Perform Acceptable Quality Limit (AQL) inspections of drug products.
• Review and approve documentation related to media and buffer preparation.
• Create or update Standard Operating Procedures (SOPs) and review Master Batch Records.
• Compile and address deviations observed on the floor, ensuring timely resolution.
• Conduct audits of manufacturing and support areas to ensure adherence to internal procedures and Good Documentation Practices.

Requirements:

A degree in Engineering or Biotech field with 0-2 years of experience in QA/QC/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. OR a Bachelor's degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in QA/QC/Manufacturing.

Skills:

Understanding of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, and 600s, ICH Guidelines, and EU GMPs. Familiarity with biological manufacturing processes, including cell banking, fermentation, purification, and fill/finish. Ability to apply scientific and regulatory principles to solve operational and quality-related challenges. Proficiency with electronic systems and software, including Microsoft products; experience with LIMS, Master Control, and Trackwise is a plus.



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