QA Specialist II/III, Lot Release

Location
Redwood City, CA
Posted
Mar 18, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for a QA Specialist II to join our team in our Redwood City office. This position reports to Teresa Lee, Senior QA Lead.  This person will be working with cross functional team members.  The QA Specialist II, Lot Release is responsible for the review and lot release of drugs products to support the clinical trials of Adverum program. 
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.
  • Interacts with contract manufacturing
  • 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.
  • 7+ 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.
  • CMO management experience

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation