The Fountain Group is currently seeking a -Quality Assurance (QA) Specialist I for a prominent client of ours. This position is located in -Lake County, IL. Details for the position are as follows:
Job Title: Quality Assurance (QA) Specialist I
Location: Lake County, IL ,Hybrid (Onsite Tuesday, Wednesday & Thursday)
Pay Rate: $26–$28/hr
Duration: 6 months
Job Description
The Quality Assurance (QA) Specialist I supports global quality operations by managing pharmaceutical, medical device, and combination product complaints. This role is responsible for complaint intake, documentation, investigation, and regulatory assessment, ensuring compliance with global quality standards and regulatory requirements.
Key responsibilities include:
- Process and document product complaints, including investigation and closure
- Review non-medical and quality-related medical complaint data
- Ensure complaint records comply with GMP, GCP, and Good Documentation Practices (GDP)
- Identify and escalate potentially reportable adverse events
- Support complaint categorization, CAPA activities, and sample return coordination
- Interface with third-party manufacturers and regulatory bodies for complaint follow-up
- Maintain audit-ready documentation aligned with global regulatory standards
Education
- Bachelor’s Degree in Life Sciences, Healthcare, or related technical field
- Equivalent experience (1–2 years) in a regulated environment may be considered
- Preferred: Clinical or healthcare background (MLT, LPN, RN)
Required Skills
- Complaint handling and investigation in pharmaceutical/medical device environment
- cGMP compliance and regulated industry experience
- Good Documentation Practices (GDP) and technical writing for quality records
- Experience with complaint management systems and quality databases
- Knowledge of product complaint workflows and CAPA processes
Preferred Skills
- Knowledge of FDA regulations: 21 CFR 803, 820, and 211
- Experience with Medical Device Reporting (MDR) and pharmacovigilance processes
- Exposure to combination products and global regulatory frameworks
- Experience working with third-party manufacturers and external audits
- Ability to manage complaint trending and quality risk assessments