QA Specialist, DSM Operations - Real-Time Quality & Validation

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QA Specialist, DSM Operations to oversee quality programs for Drug Substance Manufacturing processes. The role ensures validated state of DSM systems and supports incident triage and deviation responses.

You will work a 12-hour shift on 2-2-3 cadence (0600-1800) and collaborate with global peers to drive QA readiness and process improvements 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.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Responsibilities

• 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.
• Real time WO oversight per applicable procedures.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.

Skills

Verbal communication

Written communication

Time management

cGMP knowledge

English fluency

Education

BS/BA Life Sciences or Engineering

Master's in Life Sciences or Engineering

Tools

ASTM E2500

Smartsheet

Trackwise

MasterControl

Kneat validation software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QA Specialist, DSM Operations to oversee quality programs for Drug Substance Manufacturing processes. The role ensures validated state of DSM systems and supports incident triage and deviation responses.

You will work a 12-hour shift on 2-2-3 cadence (0600-1800) and collaborate with global peers to drive QA readiness and process improvements in a CGMP facility.