Pharma QA Specialist - Regulatory Compliance & Audits

ExpertHiring; Louisiana; On-site; USD 70,000 - 95,000; Full time

Job summary

Client Labs in Lafayette, IN is seeking a Quality Assurance (QA) Specialist to support regulatory oversight, quality systems, and compliance activities within its pharmaceutical research and analytical laboratory. You will review quality records, participate in audits and inspections, train personnel, and collaborate with scientific teams to maintain high standards of quality and regulatory compliance.

This role requires a scientific degree and a strong commitment to cGMP guidelines and

Qualifications

• Bachelor's or Master's degree in a scientific discipline or equivalent regulatory experience.
• Familiarity with cGMP or other applicable regulatory requirements.
• Excellent written and verbal communication skills.
• Strong computer proficiency and documentation skills.
• Ability to manage multiple priorities and work effectively under pressure.
• Strong teamwork and collaboration skills.
• Ability to motivate and work effectively with colleagues.
• Ability to understand and generalize experimental design.
• Ability to clearly communicate scientific ideas, research findings, and conclusions.

Responsibilities

• Review and approve deviations, CAPA, and change controls.
• Participate in client audits and regulatory inspections.
• Ensure quality systems comply with company procedures and regulatory expectations.
• Train staff and key personnel on company procedures, SOPs, and current industry requirements.
• Support product validations and designs.
• Review and audit scientific reports for accuracy, completeness, and compliance.
• Conduct internal quality audits.
• Evaluate the impact of new products or changes to existing products on regulatory applications.
• Apply established Standard Operating Procedures (SOPs) to daily activities.
• Collaborate with project teams to achieve quality and organizational objectives.
• Support ongoing quality improvement and regulatory compliance initiatives.
• Perform other duties as assigned.

Skills

Written communication

Verbal communication

Documentation

Multitasking

Teamwork

Collaboration

Scientific communication

Education

Bachelor's or Master's in science

Tools

cGMP knowledge

Job description

Client Labs in Lafayette, IN is seeking a Quality Assurance (QA) Specialist to support regulatory oversight, quality systems, and compliance activities within its pharmaceutical research and analytical laboratory. You will review quality records, participate in audits and inspections, train personnel, and collaborate with scientific teams to maintain high standards of quality and regulatory compliance.

This role requires a scientific degree and a strong commitment to cGMP guidelines and