Senior QA Operations Specialist: Batch Release & CAPA

PCI Pharma Services; Bedford (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, New Hampshire, seeks a QA Specialist II Operations to oversee batch documentation and ensure compliance with FDA regulations. The ideal candidate will have a relevant Bachelor's Degree and extensive experience in the pharmaceutical industry, particularly in QA Operations. Responsibilities include reviewing investigations, leading quality process improvements, and interfacing with clients. This role offers opportunities for professional growth in a diverse and inclusive environment.

Qualifications

• 5-7 years of experience in pharmaceutical or biotech industry with 3+ years in QA Operations.
• Knowledge of FDA regulations and experience working with ICH.
• Experience performing Root Cause Analysis and technical writing.

Responsibilities

• Perform review of batch documentation for product release.
• Review and approve master batch records for GxP manufacturing.
• Review and approve investigations and quality system events.

Skills

Technical writing

Risk management tools

Attention to detail

Interpersonal skills

Communication skills

Education

Bachelor's Degree in a relevant scientific discipline

Tools

MS Office Suite

Job description

PCI Pharma Services in Bedford, New Hampshire, seeks a QA Specialist II Operations to oversee batch documentation and ensure compliance with FDA regulations. The ideal candidate will have a relevant Bachelor's Degree and extensive experience in the pharmaceutical industry, particularly in QA Operations. Responsibilities include reviewing investigations, leading quality process improvements, and interfacing with clients. This role offers opportunities for professional growth in a diverse and inclusive environment.