Pharma QA Specialist: Syringe Project & Compliance

Spectraforce Technologies; North Chicago (IL); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Spectraforce Technologies in Waukegan, IL is seeking a Quality Assurance Specialist III for a 12-month contract to support a project converting a marketed pharmaceutical drug from vial to pre-filled syringe. The role involves coordinating change controls, investigations, CAPAs, and ensuring cGMP compliance with CMOs.

Hybrid work model: onsite Tue-Thu and remote Mon-Fri; travel minimal. Strong QA systems knowledge and project coordination are essential to drive timely quality deliverables and

Qualifications

• Bachelor’s degree in Biology, Chemistry, Life Sciences, or related field.
• 3–5 years QA experience in pharma/biopharma manufacturing.
• Foundational understanding of aseptic processing.
• Knowledge of deviations, CAPA, change controls, and complaint handling.
• Strong communication and cross-functional collaboration.

Responsibilities

• Initiate, execute, and monitor change controls, CAPA investigations, deviations/non-conformances, and product quality reviews per quality agreements and cGMP.
• Track action items, deliverables, and timelines for the syringe project; represent QA in cross-functional meetings and report updates to leadership.
• Collaborate with CMOs/contract manufacturers and support vendor discussions on quality items.
• Participate in site visits to inspect equipment, review qualification docs, and assist with troubleshooting.
• Assist in due diligence on supplier components and ensure regulatory readiness for audits.

Skills

QA experience

Aseptic processing

QMS knowledge

Project management

Communication

Education

Bachelor’s degree in Biology, Chemistry, Life Sciences, or related

Tools

TrackWise

OneVault

Job description

Spectraforce Technologies in Waukegan, IL is seeking a Quality Assurance Specialist III for a 12-month contract to support a project converting a marketed pharmaceutical drug from vial to pre-filled syringe. The role involves coordinating change controls, investigations, CAPAs, and ensuring cGMP compliance with CMOs.

Hybrid work model: onsite Tue-Thu and remote Mon-Fri; travel minimal. Strong QA systems knowledge and project coordination are essential to drive timely quality deliverables and