We are seeking a dedicated and detail-oriented Quality Assurance Associate to join our specialty lab team in Gurnee, IL. This full-time position offers a comprehensive benefits package, including medical, dental, 401K, paid time off (holiday, vacation, and sick/personal time), and eligibility for annual performance reviews.
Key Responsibilities:
- Draft and update quality documentation to ensure compliance with GMP standards.
- Maintain and control document approval, distribution, and review processes.
- Conduct comprehensive internal audits to identify non-compliance areas and document findings, outlining corrective actions.
- Ensure suppliers complete required questionnaires and adhere to compliance standards.
- Develop and update guidelines for supplier evaluation and management.
- Create training curricula for Standard Operating Procedures (SOPs) and policies, ensuring training is completed and documented in the training management system.
- Perform and document mock recalls to assess organizational readiness and effectiveness.
- Investigate and document customer complaints to resolve backlog issues effectively.
Education:
- Bachelor’s degree in quality assurance, Life Sciences (Biology, Chemistry, Biochemistry, etc.), Engineering, or a related field. Master’s degree preferred.
Experience:
- 3-5 years of experience in Quality Assurance within a GMP-regulated industry (pharmaceutical, biotechnology, or medical device).
- Proven experience in drafting and updating SOPs and other quality documentation.
- Hands-on experience in conducting internal audits and managing Corrective and Preventive Actions (CAPAs). Experience with supplier qualification and management processes.
- Familiarity with training program development and implementation.
- Experience in handling customer complaints and performing mock recalls.
Skills:
- Strong understanding of GMP, FDA regulations, and ISO standards.
- Proficiency with electronic quality management systems (eQMS) and training management systems.
