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Quality Assurance Specialist

Spectraforce Technologies
United States, Illinois, North Chicago
Apr 04, 2025
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.