QA Scientist

The QA Shop Floor Scientist is responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. This role will also require review and approval of validation/ qualification documentation for facility, equipment and systems. 

Expect to work evening shifts 1-2 times a week Monday-Friday and on the call on weekend once in a while.

The role (daily responsibilities): 

• Review all batch documentation, liaising with production management to resolve and clarify any points of issue.
• Provide an “on-line” Quality presence in the production area during manufacture with particular regard to on-line document and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials
• Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs
• Perform Quality review and approval of minor deviations
• Conduct batch record “Stage Approval” as part of batch release process
• Participate in Gemba walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.
• Work with production team to drive improvements in GMP compliance across all shifts
• Shipping/ prepacking approval
• Manufacturing label management 
• Archiving 
• Buffer and media review
• Buffer MPR approval
• Review and approval of validation/ qualification documentation
• Perform other duties as assigned

Education and experience:  

• Minimum Science based degree
• Minimum 5y of experience - the role is a senior level specialist
• Substantial experience working in or directly supporting manufacturing within a drug product/ substance manufacturing site
• Previous biopharma experience is preferred
• Strong working knowledge of the principles and guidelines for GMP
• Strong decision maker and ‘can do’ attitude 
• Excellent written and verbal communication skills to internal and external stakeholders
• Ability to work in a fast paced, matrix environment is essential
• Capable of working to deadlines and prioritizing multiple tasks
• Flexibility to meet changing needs and priorities of the business
• Experience working in a GMP aseptic manufacturing environment  

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.

 

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

 

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.