QA Floor Operations Specialist I

PCI Pharma Services; Bedford (NH); On-site; USD 60,000 - 76,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist I - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection for clinical and commercial drug products in a GMP facility. The role includes real-time documentation review, batch record assessment, and supporting line changes.

Qualified candidates will hold a scientific degree and have GMP exposure; additional experience with deviations, CAPA, and quality systems is valued.

Qualifications

• Bachelor's Degree in a relevant scientific field.
• Minimum 2 years' experience in GMP industry preferred.
• Exposure to RCA, technical writing, and quality investigations.
• Lean operation excellence experience desirable.
• Knowledge of FDA regulations (21 CFR 210, 211 & 820) and ICH guidelines.
• Familiarity with Risk Management Tools (FMEA, HACCP, PHA) and ICH Q9 preferred.
• Ability to apply scientific principles to solve routine quality tasks.
• Ability to articulate scientific and technical information clearly.

Responsibilities

• Perform on-the-floor QA activities supporting client projects and room release.
• Review GMP documentation and batch records in real time; ensure compliance.
• Support nonconforming material investigations and CAPA processes.
• Assist in material disposition of intermediates and finished products.
• Review and approve SOPs and raw material specifications.
• Act as first responder for on-floor quality issues and investigations.

Skills

GMP knowledge

Technical writing

Problem solving

Communication

Education

Bachelor's degree in science

Tools

MS Office

Excel

Word

Job description

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist I - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection for clinical and commercial drug products in a GMP facility. The role includes real-time documentation review, batch record assessment, and supporting line changes.

Qualified candidates will hold a scientific degree and have GMP exposure; additional experience with deviations, CAPA, and quality systems is valued.