1035 O'Brien Drive
Industry: Clinical & Scientific
Job Number: 15700
Senior QA Document Control and Training Specialist
Menlo Park, CA
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 has collaboration agreements with Regeneron Pharmaceuticals to research, develop, and commercialize gene therapy products for ophthalmic diseases and Editas Medicine to explore the delivery of genome editing medicines for the treatment of inherited retinal diseases. 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.
Our Quality Assurance team is looking to bring onboard a Senior Quality Assurance Document Control and Training Specialist. This individual will perform and maintain QA programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical drug substance and drug product manufactured at Contract Service Providers.
Core Job Responsibilities:
- Independently facilitate the Document Request process including providing formatting, coordinating the review and approval process, tracking and routing controlled documents.
- Independently work on electronic and hardcopy history files of controlled documents, ensuring accurate and reliable filing systems.
- Maintains the archival of master documents and records (both hardcopy and electronic) such that required documentation is retrievable and files are accurate, complete and well organized.
- Maintains the security and integrity of all files and ensures that no document is lost or accidentally discarded/destroyed.
- Issues Change Control, CAPA and Deviation numbers to ensure compliance with Company procedures, cGMP, and other applicable regulations.
- Represents QA and provides support to internal team meetings as needed for any electronic implementation i.e. Sharepoint system.
- Provides and prepares quality metrics and reports
- Initiates and revises SOPs as required.
- Copy, scan, and distribute controlled documents as needed.
- Issues, tracks and/or reconciles controlled test record forms, logbooks and laboratory notebooks.
- Performs Annual GxP training and QA SOPs training for Adverum employees.
- Performs QA “ on-boarding” orientation for new employees.
- Maintains archival of offsite storage.
- Other responsibilities as assigned
- Minimum BA/BS Degree in biological sciences, chemistry, or related field and/or equivalent experience.
- 7+ years of Quality Assurance (QA) pharmaceutical experience in a GxP environment preferably in an advanced therapy, such as gene therapy.
- Excellent working knowledge and understanding of GxP related requirements, proficiency in applying regulatory and ICH guidelines. Broad experience in the bio-pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D experience a plus.
- Detail oriented with Quality Assurance background. Ability to work effectively in a team environment with exceptional organizational skills.
- Excellent working knowledge of Document Control, Quality Systems and GxP standards applicable to product life cycle from development to commercial.
- Ability to provide training with excellent public speaking skills.
- A self- starter, highly motivated individual with interpersonal skills.
- Experience with developing and reporting quality metrics.
- Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility.
- Excellent verbal and written communication
- Proficient with computers and word processing software (Microsoft Office products).