Quality Assurance Specialist

Job Title: Quality Assurance (QA) Specialist III Duration: 12 Months Location: Waukegan, IL 60085 (Lakeside Drive) Work Model: Hybrid (Onsite: Tuesday, Wednesday, Thursday | Remote: Monday, Friday) Schedule: Monday - Friday, 8:00 AM - 5:00 PM Travel: Low-to-moderate (Estimated 3-4 domestic trips per year / up to 10-20% as needed) Role Overview The QA Specialist III will provide quality assurance and project-level quality support within an External Product Quality (EPQA) environment. This role directly supports a critical project converting a marketed pharmaceutical drug product from a vial to a pre-filled syringe presentation. Working closely with project leads, this individual will assist in managing quality workflows with third-party contract manufacturing organizations (CMOs/contractors), executing change controls, conducting investigations, tracking CAPAs, and driving project actions to ensure strict compliance with cGMP and regulatory standards. Key Responsibilities Change Control & Quality Systems: Initiate, execute, and monitor Change Controls, CAPA investigations, deviations/non-conformances, and product quality reviews in accordance with quality agreements and cGMP guidelines. Project Quality Support: Track action items, deliverables, and timelines for the new syringe presentation project; represent the quality team in cross-functional project meetings and communicate updates back to leadership. Third-Party Contractor (CMO) Collaboration: Partner with the project lead to support interactions with third-party manufacturers, assist during vendor discussions, and follow up on quality-related action items. Equipment & Site Readiness: Participate in site visits (e.g., to third-party manufacturing facilities) to inspect incoming equipment, review qualification documentation, and assist with technical troubleshooting. Supplier & Component Due Diligence: Assist in investigating component issues (e.g., faulty parts, delivery discrepancies) and conduct background assessments/research on secondary suppliers and component vendors. Process & Planning Optimization: Coordinate with site QA planners and global quality initiatives; analyze cycle times, touch times, and process metrics to drive QA workflow efficiency. Risk Management: Identify potential quality risks early in the project lifecycle, develop mitigation/fallback plans, and report status/metrics to quality leadership. Audit & Inspection Support: Assist in gathering documentation and supporting audit/regulatory inspection readiness for new market introductions. Required Qualifications & Experience Education: Bachelor's degree in Biology, Chemistry, Life Sciences, or a related technical/engineering discipline. Experience: 3 to 5 years of hands-on Quality Assurance experience within the pharmaceutical or biopharmaceutical manufacturing industry. Aseptic Processing: Foundational understanding and familiarity with aseptic manufacturing environments and sterile fill-finish operations. Core Quality Systems (QMS): Solid working knowledge of deviations, root cause analysis/investigations, CAPA management, change controls, and complaint handling. Project Management Skills: Proven ability to organize multiple priorities, maintain action logs, manage deliverables, and thrive in a fast-paced environment. Communication & Collaboration: Strong verbal, written, and interpersonal communication skills to liaise effectively between external manufacturing partners and internal cross-functional teams. Preferred / Nice-to-Have Qualifications Combination Products / Medical Devices: Prior experience with drug-delivery systems, syringes, autoinjectors, or medical devices is a strong plus. QMS Platforms: Experience working in systems like TrackWise, OneVault, or similar electronic document and deviation management platforms (hands-on experience with specific software is not mandatory; transferable QMS knowledge is accepted). External / CMO Quality: Familiarity working with external contract manufacturers or third-party quality agreements. #J-18808-Ljbffr