QA Specialist - cGMP Lab & Regulatory Compliance

ExpertHiring, LLC; Lafayette (LA); On-site; USD 70,000 - 95,000; Full time

Job summary

Client Labs, a pharmaceutical research and analytical laboratory in Lafayette, IN, seeks a Quality Assurance Specialist to support regulatory oversight, quality systems, and compliance activities. The role involves reviewing quality records, audits, training personnel, and collaborating with scientific teams to uphold quality standards.

The ideal candidate has a scientific degree, familiarity with cGMP, and strong communication skills to ensure documentation accuracy and regulatory alignment

Qualifications

• Bachelor's or higher in a scientific field or regulatory-equivalent experience.
• Familiarity with cGMP or other regulatory requirements.
• Excellent written and verbal communication skills.
• Strong computer proficiency and documentation skills.
• Ability to manage multiple priorities and work under pressure.

Responsibilities

• Review and approve deviations, CAPA, and change controls.
• Participate in client audits and regulatory inspections.
• Ensure quality systems comply with procedures and regulatory expectations.
• Train staff on SOPs and current industry requirements.
• Review and audit scientific reports for accuracy and compliance.
• Perform internal quality audits.

Skills

Regulatory understanding

Quality systems

Documentation skills

Communication skills

Teamwork

Education

Bachelor's degree in scientific discipline

Master's degree in scientific discipline

Tools

CAPA system

Document control software

Job description

Client Labs, a pharmaceutical research and analytical laboratory in Lafayette, IN, seeks a Quality Assurance Specialist to support regulatory oversight, quality systems, and compliance activities. The role involves reviewing quality records, audits, training personnel, and collaborating with scientific teams to uphold quality standards.

The ideal candidate has a scientific degree, familiarity with cGMP, and strong communication skills to ensure documentation accuracy and regulatory alignment