Quality Assurance Specialist

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

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.