Summary
The Specialist QA (CMO) position is an individual contributor role responsible for supporting Supplier Qualification activities and QA oversight of CMO viral vector manufacturing operations in accordance with business agreements and international regulatory and industry standards.
Knowledge, Skills, and Abilities :
Education :
Associate degree or Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or related areas, or equivalent work experience.
Experience
5+ years related industry experience with a minimum of 3 years experience in quality assurance, quality control, and compliance.
Knowledge of applicable FDA / EMA regulations in the biotechnology industry.
Strong organizational skills, including ability to follow assignments through to completion.
Experience supporting contractor negotiations.
With moderate oversight from manager, think strategically and understand global impact of decisions.
Excellent verbal and written communication skills.
Detail-oriented with demonstrated applications in problem solving.
Preferred Qualifications :
Experience within the Cellular Therapeutics and / or gene-based products.
Experience with Commercial products manufacture, supply and post-approval change management
Experience managing external suppliers and other supply chain issues.
Advanced project management skills such as process excellence / six sigma methods and approaches including process mapping, root cause analysis and problem definition.
DUTIES AND RESPONSIBILITIES :
Partner closely with Clients External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners.
Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
Effectively communicate issues, risks and proposed solutions within the organization.
Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
Provide communication, support, and guidance to manufacturing partners and within the QA CMO team.
Conduct reviews of CMO batch records, evaluate deviation investigations, changes and batch disposition
Proven ability to work effectively in a matrixed organization
Support internal and external audits as needed
Create and revise Standard Operating Procedures as needed.
Other duties as assigned.
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