QA Operations Specialist: Real-Time QA & cGMP Validation

FUJIFILM Biotechnologies; Holly Springs (NC); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

FUJIFILM Biotechnologies is seeking a QA Specialist, Operations to partner in quality oversight of Drug Substance Manufacturing processes. You will ensure DSM systems and processes are operated in a validated state throughout their lifecycle, with focus on policy administration.

Responsibilities include QA support of DSM tasks, real-time deviation response, changeovers, KPI alignment, and development of QA documentation for operational readiness in a cGMP facility.

Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience; OR,
• Masters in Life Sciences or Engineering or equivalent with 0 years’ relevant experience.
• 1-3 years’ experience in a GMP environment.

Responsabilités

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as: Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool.
• Real time event triage and implementation of immediate response to identified deviations.
• Area changeover and return to service.
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs.
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.
• Perform other duties, as assigned.

Connaissances

Communication

Time management

GMP knowledge

Data integrity

21 CFR Part 820/11

Cross-functional collaboration

Travel flexibility

English fluency

Formation

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

Description du poste

FUJIFILM Biotechnologies is seeking a QA Specialist, Operations to partner in quality oversight of Drug Substance Manufacturing processes. You will ensure DSM systems and processes are operated in a validated state throughout their lifecycle, with focus on policy administration.

Responsibilities include QA support of DSM tasks, real-time deviation response, changeovers, KPI alignment, and development of QA documentation for operational readiness in a cGMP facility.