Senior QA Floor Operations Specialist

PCI Pharma Services; Bedford (NH); On-site; USD 75,000 - 95,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist II to provide on-the-floor QA support for Manufacturing and Visual Inspection in a GMP Bedford, NH facility. You will oversee formulation, aseptic processes, vials inspection, and batch records while ensuring regulatory compliance and timely corrective actions.

You will collaborate with Operations, QC, Facilities, and Project Management to resolve issues, review GMP documentation in real time, and support site quality improvement initiatives.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Minimum 3 years’ experience in GMP industry, with at least 1 year in Quality.
• ASQ certification is a plus.
• Exposure to RCA, technical writing, and quality investigations.

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues during manufacturing.
• Consult with Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations.
• Conduct walkthroughs and internal audits of manufacturing areas to ensure adherence to policies and procedures.
• Batch record review for adherence to internal procedures and Good Documentation Practices.
• Support evaluation and disposition of intermediates, finish bulk drug substance, and drug product.
• Review and disposition of incoming materials such as consumables, excipients, and API.
• QA review and approval of new and revised GMP documents (SOPs, raw material specs).
• Act as first responder for on-the-floor quality issues with proper documentation and CAPA initiation.

Job description

PCI Pharma Services is seeking a QA Specialist II to provide on-the-floor QA support for Manufacturing and Visual Inspection in a GMP Bedford, NH facility. You will oversee formulation, aseptic processes, vials inspection, and batch records while ensuring regulatory compliance and timely corrective actions.

You will collaborate with Operations, QC, Facilities, and Project Management to resolve issues, review GMP documentation in real time, and support site quality improvement initiatives.