What are the responsibilities and job description for the Quality Assurance Specialist #ESF9261 position at COA Network Inc?
About Client:
Position Summary
Key Responsibilities
Required Qualifications
Preferred Qualifications
Physical Requirements
- 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.