What are the responsibilities and job description for the Quality Assurance QC Compliance (Specialist & Engineer position at FUJIFILM Diosynth Biotechnologies?
Join us as a QA Specialist/Engineer, QC Compliance!
We're on the lookout for a talented QA Specialist to oversee Quality Control operations. This role is pivotal in driving Quality oversight across all QC laboratory processes, from the project phase through to operational readiness. You'll ensure that validation program execution is top-notch and collaborate with various project teams and QA departments to align strategies and procedures.
Key Responsibilities:
- Provide QA oversight and support for project deliverables, ensuring adherence to governing processes and procedures.
- Assess the impact of system and process modifications, maintaining oversight of change management processes to ensure systems are validated and maintained.
- Oversee and approve lifecycle documentation, including risk and impact assessments, specifications, qualification protocols, and validation plans.
- Generate, review, and approve QA procedures for validation and operational readiness in cGMP regulated facilities.
- Ensure quality objectives are met within desired timelines, actively seeking collaboration opportunities to streamline processes.
- Adapt to evolving project needs as startup activities transition into operations.
- Perform additional duties as assigned.
Minimum Requirements for Specialist Level:
- Bachelor's degree in Life Sciences or Engineering with 2 years of experience, OR
- Master's degree in Life Sciences or Engineering with 1 year of experience.
- 1 years of experience in GMP Quality Assurance or a similar role.
Minimum Requirements for Engineer Level:
- BS/BA in Life Sciences or Engineering or equivalent with 6 years of applicable industry experience.
- 3 years of experience in GMP Quality Assurance or a similar role.
The Engineer level demands a higher level of experience and applicable industry exposure compared to the Specialist level.
Preferred Requirements for Engineer Level:
- MS in Life Sciences or Engineering with 4 years of applicable experience, or a PhD in Life Sciences or Engineering.
- Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl, and/or Kneat validation software.
- Understanding of cell culture, upstream processes, large scale recovery, and/or downstream processes.
- Experience with startup projects or initiatives.
- Fully embraces a Genki culture, bringing positive energy to a dynamic work environment.
- Occasional opportunity for international and/or domestic travel may be available.
- Training and/or familiarity with Quality Risk Management principles preferred.
