Specialist 2, Quality Assurance Technical

About the role

The QA Technical Specialist II performs final disposition of GMP raw materials and consumables to ensure timely availability for manufacturing. Serving as the QA point of contact for Warehouse, Supply Chain, and QC Raw Materials, this role resolves material-related issues and escalations, conducts quality impact assessments for investigations, change controls, and supplier change notifications, and ensures compliance with applicable procedures and data integrity requirements.

Responsibilities

• Execute QA disposition of GMP raw materials and consumables to support manufacturing schedules.
• Update and manage material status and associated records in SAP.
• Contribute to and review quality system records (e.g., deviations, change management, change controls) in TrackWise.
• Perform quality impact assessments for investigations and supplier change notifications related to raw materials/consumables.
• Collaborate with Warehouse, Supply Chain, QC Raw Materials, and Quality leadership to resolve issues, drive timely decisions, and maintain flow of materials.
• Review and adhere to applicable SOPs and work instructions; identify and support procedural improvements.
• Uphold data integrity and ensure compliance with 21 CFR Part 820 and Part 11, and internal quality standards.

Requirements

• High School Diploma or equivalent with 9+ years applicable industry experience; OR Associate’s degree with 7+ years; OR Bachelor’s degree with 5+ years; OR Master’s degree with 3+ years.
• Hands-on experience with SAP (material status/transactions) and Microsoft Office.
• Experience working within GMP quality systems (deviations, change control, investigations).
• Strong written and verbal communication, organization, critical thinking, and attention to detail.
• Demonstrated ability to multitask, prioritize, and meet timelines in a GMP environment.

Qualifications

• Bachelor’s degree with 5+ years applicable industry experience preferred.
• TrackWise experience for deviations and change management preferred.
• Supplier quality and/or material control experience in a regulated manufacturing environment preferred.
• Proven ability to influence and collaborate across Supply Chain, QC, and QA preferred.

Skills

• Quality systems (investigations, change control), data integrity, problem solving, conflict resolution.
• Cross-functional stakeholder management; ability to work independently with minimal daily direction.
• Agility and flexibility in a fast-paced, schedule-driven environment.

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays.