Job Description

• The Quality Assurance (QA) Operations Specialist will be a key team member for the GMP Manufacturing facility .
  
  
  
  
• QA Specialist will be responsible for product batch record reviews, batch release and batch disposition
  
  
  
  
• Oversees production room clearances and provides the QA support on the manufacturing shopfloor
  
  
  
  
• Support manufacturing shopfloor to ensure the aseptic techniques and good cleaning room behaviors are followed.
  
  
  
  
• Oversee and assist the deviation investigations and ensuring the on-time closure of the deviations.
  
  
  
  
• Provide QA support for the QC activities, including the review of QC testing records, SOPs and reports.
  
  
  
  
• Create, revise, and implement quality assurance standard operation procedures and work instructions for the site when necessary.
  
  
  
  
• Conduct data analysis to support tracking of Key Quality Performance Indicators and generate the quality metrics monthly reports.
  
  
  
  
• Ensure Manufacturing and QC laboratory operations are in compliance with the global regulatory requirements.
  
  
  
  
• Support internal audits and assist regulatory inspections (e.g., prep room participant, subscriber)
  
  
  
  
• Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines pertaining to Quality Systems.

• Degree in Biology, Microbiology, Biochemistry, or other life sciences from an accredited university or college
  
  
  
  
• 6+ years of experience in QA or GMP environment or equivalent.
  
  
  
  
• Working experience in Biotechnology is highly desired but working experience in pharmaceuticals or related field such as cell therapy is a must.
  
  
  
  
• Strong working knowledge of GMP Regulations and ICH Guidelines governing current Good Manufacturing Practices for Pharmaceuticals and Biotechnologies.
  
  
  
  
• Must be comfortable in a fast-paced environment with minimal direction and changing priorities
  
  
  
  
• Strong interpersonal skills and ability to work collaboratively across functions
  
  
  
  
• Growth-oriented with a continuous improvement mindset, and passionate about working with others in a complex manufacturing environment.

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