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Quality Assurance Specialist #ESF9261
Job Location:
Job Location:
Lafayette, IN - USA
Yearly Salary:
$ 60000 - 70000
Yearly Salary:
Posted:
22 October 2026 (Yesterday)
Posted:
Application Deadline:
19 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
About Client:
- Founded in 2009 Client Labs is a specialized pharmaceutical research and analytical laboratory based in Lafayette Indiana.
- The company helps pharmaceutical and specialty chemical organizations solve complex materials challenges through solid-state development physical and analytical chemistry advanced characterization cGMP laboratory services and chemical intellectual property support.
- Client is recognized for its scientific expertise innovative analytical approaches and commitment to delivering reliable meaningful results that support pharmaceutical development and regulatory decisions.
Position Summary
- Our Lab Client is seeking a Quality Assurance (QA) Specialist to support regulatory oversight quality systems and compliance activities within its pharmaceutical research and analytical laboratory.
- The QA Specialist will help ensure that laboratory operations documentation and quality processes comply with established company procedures and applicable regulatory requirements.
- This position involves reviewing quality records supporting audits and inspections training personnel and collaborating with scientific teams to maintain high standards of quality and regulatory compliance.
Key Responsibilities
- Review and approve deviations corrective and preventive actions (CAPA) and change controls.
- Participate in client audits and regulatory inspections.
- Ensure quality systems comply with company procedures and applicable 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.
Required Qualifications
- Bachelors or Masters degree preferably 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.
Preferred Qualifications
- Previous experience in a cGMP-regulated environment.
- Experience in pharmaceutical analytical laboratory or related regulated environments.
- 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.
Physical Requirements
- Ability to occasionally lift or move up to 30 lbs.
- Ability to sit stand and walk for extended periods in office and laboratory environments.
- Ability to move between laboratory instruments and work areas.
- Ability to work in a laboratory testing environment.
- Ability to work in moderate to high noise-level environments.
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