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Qa Specialist Jobs in Indiana

Quality Assurance Specialist #ESF9261

ExpertHiring

  • Lafayette, IN
  • 2 days ago

    Highlights

    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. 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.

    Numbers & Facts

    LocationLafayette, IN

    Description

    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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