Quality Assurance Specialist III

Job Title: Quality Assurance Specialist III

Duration: 12 months (possible extension)

Location: Mettawa, IL 60045

Working hours: M-F, 8-4:30 (hours can be flexed)

Description:

• The role supports two key areas in clinical operations: Drug Product Pipeline – Focuses on manufacturing tablets and oral fill solutions for clinical trials. Finishing Plant – Takes large batches of drug products (e.g., drums of tablets), bottles them (e.g., 50 tablets per bottle), and distributes them.
• Engages cross-functionally to investigate and document compliance events, ensuring timely resolution to enable program timelines.
• Works with Databases and electronic systems.
• Follows through with business partners to receive investigation results, actions planned, and closure of actions by requesting and reviewing objective evidence.
• Collects relevant monthly and quarterly metrics.
• Involves quality assurance oversight, ensuring compliance with GMP and investigating deviations (e.g., tablet defects, labeling issues, or procedural violations).
• Project management responsibilities include tracking investigations, setting up communication (emails, follow-ups), and ensuring quality tasks are completed on time.
• We use TrackWise for quality management (transitioning to OneTrack next year). Experience with either system is preferred.
• Cross-functional collaboration with PhDs, chemists, engineers, manufacturing personnel, and quality teams—requires strong communication and negotiation skills.
• Investigations require knowledge of timing requirements, root cause analysis, and GMP principles. The specialist ensures investigations are completed but does not lead them.

Must-Have Skills:

• GMP experience with a strong understanding of compliance principles.
• Scientific background to support investigations and documentation.

What we are looking for:

• Bachelor’s degree in a scientific field is required. A master’s degree (especially in a scientific discipline) can be helpful,
• Experience: Minimum 2 years required, 4 years preferred in pharmaceutical quality assurance, compliance, or CAPA investigations.
• Experience with inventory tracking systems (SAP or other similar systems) is beneficial for managing quality records.
• Pharmaceutical or highly regulated industry experience is required. (Medical device experience is acceptable for this role.
• Previous experience in CAPA, Lean Six Sigma, Quality Assurance, and program management.
• Demonstrated experience in technical writing, managing program timelines, and leading diverse teams.
• GMP (Good Manufacturing Practices) compliance is a critical requirement for this role.
• Writing sample is required – Must demonstrate an understanding of GMP principles and CAPA processes. Candidates must provide a writing sample to demonstrate their understanding of GMP principles and CAPA processes (AI-generated writing samples will be rejected—the hiring manager wants to assess the candidate’s actual writing and comprehension skills.)
• Project management experience is a must-have – formal certification is not required, but candidates must have experience managing projects or initiatives.
• Experience with TrackWise or OneTrack (quality management systems) is beneficial. Familiarity with SAP or other inventory tracking systems is also needed.

Skills:

• Must be an Effective Communicator. Strong technical writing skills; Clear, concise and effective in written communication; Self-starter, takes initiative and owns the task, Organized.
• Ability to lead a diverse team and drive results.
• Adept at learning and utilizing multiple electronic systems. Proficient in MS Office Suites.