QA Specialist II - Batch Record Review and Lot Release

Redwood City, CA 94063

Posted: 04/07/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17369

Job Description


 

QA Specialist II - Batch Record Review and Lot Release

What You’ ll Do
  • Independently reviews and approves master batch records, executed batch records, labels, specifications, and other manufacturing documents for cell banks, drug substance (DS), and drug products (DP) under clinical development in compliance with US FDA, ICH and international health agency requirements as appropriate.
  • Independently reviews and approves executed manufacturing batch records, analytical data, test records, stability data, certificate of analysis, certificate of testing, environmental reports and associated documentation, including any deviations, investigation reports, and change control related to material disposition.
  • Represents QA and provides support to internal team meetings as needed.
  • Initiates and updates SOPs as required.
  • Other responsibilities as assigned

About You
  • Minimum BA/BS Degree in biological sciences, chemistry, or related field.
  • 3+ years of Quality Assurance (QA) pharmaceutical experience in a GMP environment preferably in gene therapy.  
  • Excellent working knowledge and understanding of cGMP related requirements and proficiency of regulatory and ICH guidelines. Broad experience in the bio-pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus.
  • Detail-oriented with Quality Assurance background and solid problem-solving skills. Ability to work effectively in a team environment with great organization skills.
  • Excellent working knowledge of Quality Systems and cGMP standards applicable to product life cycle from development to commercial.
  • Ability to analyze and reconcile moderate to complex issues.
  • Must be an individual with proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility.
  • Excellent verbal and written communication and interpersonal skills.
  • Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility.
  • Proficient with computers and word processing software (Microsoft Office products)

 

 

Meet Your Recruiter

Neyba Soto

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