Compliance Audit & Administration Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist – Compliance to provide essential administrative support to the Compliance team and manage client and internal audit documentation. The role coordinates audits, maintains schedules, and ensures accurate record-keeping in a regulated biopharma environment.

Reporting to the Director of Quality Systems & Compliance, you will also support during FDA inspections and drive continuous improvement within the team.

Qualifications

• Associates degree plus 5 years of relevant experience or HS diploma with 10 years relevant experience.
• Experience in office coordination, administrative support, or documentation management in regulated industries preferred.

Responsibilities

• Provide administrative support to the Director of Quality Systems & Compliance and the Compliance team.
• Coordinate client and internal audits: secure rooms, schedule meetings, organize documents.
• Manage compliance spreadsheets for audit schedules and responses.
• Transfer audit observations to PCI audit response templates.
• Support FDA and other regulatory inspections as directed.
• Maintain electronic and physical filing systems for documentation.

Skills

Office coordination

Administrative support

Documentation management

MS Office (Word, Excel, Access, Visio)

Communication skills

Education

Associates degree

HS diploma with 10+ years experience

Tools

MS Office

Job description

PCI Pharma Services is seeking a QA Specialist – Compliance to provide essential administrative support to the Compliance team and manage client and internal audit documentation. The role coordinates audits, maintains schedules, and ensures accurate record-keeping in a regulated biopharma environment.

Reporting to the Director of Quality Systems & Compliance, you will also support during FDA inspections and drive continuous improvement within the team.