QA Floor Operations Specialist II - Real-Time Quality

PCI Pharma Services; Bedford (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

PCI Pharma Services seeks a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight in a GMP facility in Bedford, NH. You will observe aseptic processes, perform AQL visual inspections, review batch records, and ensure regulatory compliance across manufacturing lines.

The role requires a bachelor’s degree in a scientific field with at least 3 years in GMP (1+ year in QA). Strong collaboration with cross-functional teams and experience with QA systems are essential.

Qualifications

• Bachelor’s degree in a relevant scientific field is required.
• Minimum 3 years’ GMP experience with at least 1 year in Quality.
• ASQ certification is a plus; exposure to RCA and quality investigations.

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release and real-time GMP documentation review.
• Consult with Operations, QC, Facilities/Engineering, PM and Materials to resolve issues.
• Conduct frequent walkthroughs and internal audits of manufacturing areas to ensure policy adherence.
• Perform batch record review for compliance with procedures and GDP.
• Review and disposition incoming materials and changes impacting manufacturing facilities.
• Lead or participate in deviations, CAPA and nonconformances within the quality system.

Skills

QA on-the-floor

GMP documentation

Visual inspection

Batch record review

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s degree in a relevant scientific field

ASQ certification

Tools

QMS software

Deviation/CAPA processes

Job description

PCI Pharma Services seeks a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight in a GMP facility in Bedford, NH. You will observe aseptic processes, perform AQL visual inspections, review batch records, and ensure regulatory compliance across manufacturing lines.

The role requires a bachelor’s degree in a scientific field with at least 3 years in GMP (1+ year in QA). Strong collaboration with cross-functional teams and experience with QA systems are essential.