Quality Control Specialist Details

Quality Control Specialist

splintpharma - remote

Employment Type : Full-Time

Responsibilities include but are not limited to:

• Serve as a Quality technical SME on a cross functional special project
  • Acts as QC Record Owner of a subset of quality records, including Deviation, CAPA, OOS and Change Control
  • Drivethese quality records to successful closurein partnership with cross functional SMEs and Record Owners (i.e. Quality, Regulatory)
  • Conduct and document detailed investigations independently
  • Lead and support continuous improvements of Quality processes to enhance efficiency and compliance
  • Aidin statistical data analysis and investigation plan designing.
• Provide technical support of GMP QC operations and staff.
  • Author, revise, and review GMP supporting documentation (SOP’s, Test Records, Forms, etc.)
• Support internal and external audits and inspections as needed
• Perform other duties as assigned

Minimum Requirements:

• Bachelor's degree in engineering or life science
• Minimum 3 years' experience in cGMP Quality Controlfor biologics and/or vaccine manufacturing
• Demonstrates interpersonal, technical aptitude, and problem-solving skills
• Knowledgeable in systematic root cause analysis methodologies and their application of these methodologies 
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)
• Excellent verbal, written, and interpersonal communication skills
• Proficiency in Microsoft products, including Microsoft Office applications, Microsoft Teams, Microsoft SharePoint, PowerBI
• Experience with Quality Management Systems & statistical analyses is preferred