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)

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.

• 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.

• 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.

• 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 Track Wise, One Vault, 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.