Quality Assurance Specialist #ESF9261

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

• Bachelor's or Master's 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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