Quality Assurance Specialist #ESF9261

ExpertHiring, LLC; Lafayette (LA); On-site; USD 70,000 - 95,000; Full time

Job summary

Client Labs, a pharmaceutical research and analytical laboratory in Lafayette, IN, seeks a Quality Assurance Specialist to support regulatory oversight, quality systems, and compliance activities. The role involves reviewing quality records, audits, training personnel, and collaborating with scientific teams to uphold quality standards.

The ideal candidate has a scientific degree, familiarity with cGMP, and strong communication skills to ensure documentation accuracy and regulatory alignment

Qualifications

• Bachelor's or higher in a scientific field or regulatory-equivalent experience.
• Familiarity with cGMP or other regulatory requirements.
• Excellent written and verbal communication skills.
• Strong computer proficiency and documentation skills.
• Ability to manage multiple priorities and work under pressure.

Responsibilities

• Review and approve deviations, CAPA, and change controls.
• Participate in client audits and regulatory inspections.
• Ensure quality systems comply with procedures and regulatory expectations.
• Train staff on SOPs and current industry requirements.
• Review and audit scientific reports for accuracy and compliance.
• Perform internal quality audits.

Skills

Regulatory understanding

Quality systems

Documentation skills

Communication skills

Teamwork

Education

Bachelor's degree in scientific discipline

Master's degree in scientific discipline

Tools

CAPA system

Document control software

Job description

Job 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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