QA Specialist, DSM Operations – Shift, cGMP Oversight

Merck & Co.; Holly Springs (NC); On-site; USD 80,000 - 105,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a QA Specialist for DSM Operations. You will oversee QA of manufacturing processes, validate DSM systems, and ensure policy adherence in a 24/7, cGMP environment.

Role requires strong communication, GMP knowledge, and ability to work across global teams, with occasional travel. On-site position with a 12-hour shift cadence may apply.

Qualifications

• Minimum 2+ years in a GMP environment.
• Experience with validation and QA oversight in manufacturing.

Responsibilities

• Provide QA oversight of DSM operations per governing processes.
• Review batch records and solution lots with exception-based oversight.
• Perform real-time event triage and implement immediate deviations response.
• Support 24/7 manufacturing by ensuring compliance and readiness.

Skills

Communication skills

Time management

cGMP knowledge

English fluency

Quality mindset

Cross-functional collaboration

Education

BS/BA in Life Sciences or Engineering

Masters in Life Sciences or Engineering

Tools

Trackwise

MasterControl

Kneat validation

Smartsheet

ASTM E2500

Job description

Fujifilm Biotechnologies in Holly Springs, NC seeks a QA Specialist for DSM Operations. You will oversee QA of manufacturing processes, validate DSM systems, and ensure policy adherence in a 24/7, cGMP environment.

Role requires strong communication, GMP knowledge, and ability to work across global teams, with occasional travel. On-site position with a 12-hour shift cadence may apply.