QA Floor Operations Specialist I – GMP Quality

PCI Pharma Services; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH, is seeking a QA Operations Specialist I – Floor Support to provide on-the-floor quality oversight for manufacturing and visual inspection activities in a GMP facility. The role involves real-time QA review, batch record checks, and disposition of materials to ensure compliance with regulatory requirements.

The candidate will support deviations, CAPAs, and quality systems, collaborating with manufacturing teams to drive continuous improvement while upholding

Qualifications

• Bachelor’s degree in a relevant scientific field required.
• Minimum 2 years’ GMP industry experience preferred.
• Knowledge of FDA regulations (21 CFR Part 210, 211 & 820) and ICH exposure.
• Experience with quality investigations, deviations, CAPA and GMP documentation.

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release and auditing critical processes.
• Conduct periodic walkthroughs of manufacturing and support areas to ensure policy adherence.
• Review batch records for compliance with internal procedures and Good Documentation Practices.
• Review and disposition of incoming materials such as consumables, excipients, and active pharmaceutical ingredients.
• Review, approve and disposition of GMP documents such as SOPs and raw material specifications.
• Act as first responder for on-the-floor quality issues and document investigations and corrective actions.
• Assist in nonconforming material investigations and quality control data review.
• Participate in site quality and process improvement initiatives and projects.

Skills

GMP quality assurance

On-the-floor QA

Documentation review

Regulatory knowledge

Risk management exposure

Education

Bachelor’s Degree in a scientific field

ASQ certification

Tools

MS Word

MS Excel

Job description

PCI Pharma Services in Bedford, NH, is seeking a QA Operations Specialist I – Floor Support to provide on-the-floor quality oversight for manufacturing and visual inspection activities in a GMP facility. The role involves real-time QA review, batch record checks, and disposition of materials to ensure compliance with regulatory requirements.

The candidate will support deviations, CAPAs, and quality systems, collaborating with manufacturing teams to drive continuous improvement while upholding