Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Experience in deviation and CAPA management, impact assessments, and root cause investigations.
- Strong technical writing, reporting, and documentation review skills.
- Effective verbal communication, interpersonal, and stakeholder‑management skills.
- Proficient in Microsoft Office applications.
- Performs a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Provide front‑line QA support to escalations, ensuring timely actions and clear resolution paths.
- Contribute to the Quality on the floor processes, including shopfloor rounds and real‑time QA support.
- Performs QA review and approval of deviations and corrective and preventive action (CAPA).
- Conducts or acts as a coordinator of investigations and CAPA recommendations related to manufactured products
- Identifies and reports deviations from approved processes and procedures to senior colleagues.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met
- Exercises judgment within well-defined established procedures and practices to determine appropriate action – identifies problems and generates alternatives and recommendations within defined processes.
- Works directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May act as mentor to junior staff with some task management responsibility.
- Contributes to QA projects and participates in cross-functional teams.
- Coordinates planning, organization and implementation of projects within specified objectives.
- Works on more complex, non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.
- Additional duties as assigned
Qualifications
Highest qualification: University
- Bachelor’s degree (BS/BA) with 3+ years of relevant experience in a GMP‑regulated environment, or Master’s degree (MS) with 1+ years of relevant experience.
- Prior experience in the pharmaceutical or biopharmaceutical industry preferred.