Quality Assurance Specialist - Pharmaceutical Research & cGMP

Job Description

Job Description

Quality Assurance Specialist | Pharmaceutical Research & cGMP

Location: Lafayette, Indiana
Salary: $60,000–$70,000/year
Schedule: Full-time

Help protect the quality and integrity of scientific work that informs pharmaceutical development and regulatory decisions.

This is an opportunity to work at the intersection of science, quality, and regulatory compliance in a specialized pharmaceutical research laboratory. Your work will help ensure that scientific reports, laboratory processes, and quality systems meet established standards, supporting reliable results for pharmaceutical and specialty chemical clients.

Join a science-driven organization known for its expertise in advanced analytical testing, materials characterization, and cGMP laboratory services. You'll collaborate with scientific teams, work with specialized laboratory operations, and contribute to continuous improvement in an environment that values scientific excellence and professional growth.

What You’ll Get

• $60,000–$70,000 annual salary.

• Exposure to specialized pharmaceutical research and cGMP laboratory operations.

• Collaboration with experienced scientists and technical teams.

• Opportunities to contribute to quality improvement and regulatory compliance initiatives.

• Professional growth in a specialized scientific environment.

What You’ll Do

• Review and approve deviations, corrective and preventive actions (CAPA), and change controls.

• Conduct internal quality audits and participate in client audits and regulatory inspections.

• Review scientific reports and quality records for accuracy, completeness, and compliance.

• Help maintain quality systems in line with company procedures and applicable regulatory requirements.

• Train personnel on standard operating procedures (SOPs) and relevant requirements.

• Support product validations and designs.

• Evaluate how new products and product changes may affect regulatory applications.

• Work with scientific and project teams to strengthen quality processes and resolve compliance issues.

What You Bring

• A bachelor’s or master’s degree, preferably in a scientific discipline, or equivalent regulatory experience.

• Familiarity with cGMP or other applicable regulatory requirements.

• Strong written communication, documentation, and computer skills.

• The ability to understand experimental design and communicate scientific findings clearly.

• Strong organization, collaboration, and prioritization skills, including the ability to work under pressure.

Preferred

• Experience in a cGMP-regulated environment.

• Background in pharmaceutical, analytical laboratory, or another regulated setting.

• Familiarity with deviations, CAPA, change control, and quality systems.

• Exposure to internal audits, client audits, or regulatory inspections.

• Experience reviewing scientific reports and regulated documentation.