QA & CSV Specialist — Automation & Validation

Planet Pharma; Holly Springs (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading pharmaceutical company in Holly Springs, North Carolina, seeks a QA specialist to provide quality support and oversight for commissioning, qualification, and Computer Systems Validation. The role involves managing QA oversight of various automation platforms, collaborating with DTI teams, and ensuring compliance with manufacturing regulations. Ideal candidates will possess relevant degrees and a strong background in quality assurance with experience in CSV and automation support.

Qualifications

• Experience in quality assurance with a focus on commissioning and qualification.
• Proven ability to manage relationships with vendors and partners.
• Familiarity with Good Manufacturing Practices and regulatory compliance.

Responsibilities

• Provide QA oversight of commissioning and qualification activities.
• Collaborate with DTI on automation platform projects.
• Review and approve qualification protocols and reports.
• Manage DTI platform activities and system administration.

Skills

Quality assurance oversight

Computer Systems Validation (CSV)

Automation support

Risk management

Education

Doctorate degree

Master's degree and 3 years of experience

Bachelor's degree and 5 years of experience

Associate degree and 10 years of experience

High school diploma / GED and 12 years of experience

Job description

A leading pharmaceutical company in Holly Springs, North Carolina, seeks a QA specialist to provide quality support and oversight for commissioning, qualification, and Computer Systems Validation. The role involves managing QA oversight of various automation platforms, collaborating with DTI teams, and ensuring compliance with manufacturing regulations. Ideal candidates will possess relevant degrees and a strong background in quality assurance with experience in CSV and automation support.