Role: Quality Assurance Specialist

Location: Lafayette, IN

Duration: Full-Time

Role Description

This position is responsible for supporting and maintaining quality systems that comply with cGMP and internal standards, including document control, deviation and CAPA management, and change control processes.

Day-to-day activities include reviewing and approving test records and reports, performing internal audits, monitoring quality metrics, and collaborating with laboratory and operations staff to resolve quality issues.

The specialist will assist in training personnel on quality procedures, participate in continuous improvement initiatives, and help prepare for client and regulatory inspections.

This role works closely with cross-functional teams to ensure data integrity, consistent laboratory practices, and reliable service delivery for clients.

Qualifications

Candidates should possess skills in Quality Assurance and Quality Control to ensure accurate testing and compliance with established standards.

Candidates should possess skills in Quality Management to support the development, implementation, and improvement of quality systems and processes.

Candidates should possess skills in Good Manufacturing Practice (GMP) to maintain cGMP-compliant operations and documentation in a laboratory environment.

Candidates should possess skills in Quality Auditing to plan, conduct, and follow up on internal audits and inspection readiness activities.

Bachelor's degree in chemistry, pharmaceutical sciences, engineering, or a related scientific discipline, or equivalent relevant experience.

Experience in a cGMP laboratory, pharmaceutical, or specialty chemical environment, with familiarity in analytical or materials characterization workflows.

Strong attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced, project-driven setting.

Effective written and verbal communication skills, with the ability to collaborate across scientific and operational teams.

Proficiency with electronic quality systems, documentation tools, and basic data analysis; experience with regulatory inspections is a plus.