QA Specialist, PQS
About The Position
The QA Specialist, PQS is responsible for the day-to-day activities of the Pharmaceutical Quality Systems team. This role requires system expertise and business knowledge to act as point of contact and maintain deep understanding of the system and process functionality/improvements and how they apply locally and globally to the system(s). The role collaborates and establishes relationships with site-based customers and global colleagues and provides updates to leadership as requested. As a system SME, the QA Specialist, PQS assists with user management, user support, problem solving and system training.
Requirements
- BS/BA in Life Sciences or Engineering or equivalent with 2+ years of applicable industry experience OR
- Masters in Life Sciences or Engineering with 0 years of applicable industry experience.
- 1-3 years of experience in a GMP environment
Nice To Haves
- Prior experience working within a QA role preferred
Responsibilities
- Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area
- Assesses the impact of system controls and process modifications and maintains oversight of change management processes
- Provides Quality/GMP oversight and approval of assigned area/systems and processes lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
- Reviews and approves QA procedures for the validation approach and lifecycle documents as assigned
- Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of assigned area/systems in cGMP regulated facility
- Ensures project and operational quality objectives are met within desired timelines
- Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
- Supports quality decisions that may impact operations, ensuring appropriate escalation
- Identifies risks and communicates gaps for quality and GMP process/systems
- Performs other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
