Senior QA Specialist - Raw Materials, GMP Pharma

Carex Consulting Group; Madison (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

Carex Consulting Group, partnering with a Pharmaceuticals industry partner, seeks a Quality Assurance professional to support the raw materials program in a GMP environment. You will contribute to supplier qualification, material risk assessment, specification development, and change control.

This is a key Supplier Quality role requiring a science degree and 5+ years in GMP QA, with experience in raw material release, EDMS/ERP systems, and regulatory expectations.

Qualifications

• 5+ years QA experience in GMP biotech or pharmaceutical environments.
• Experience with raw material release and supplier qualification.
• Knowledge of 21 CFR Parts 210/211, ICH Q7 and global regulatory expectations.

Responsibilities

• Draft, edit, review, and approve material specs and qualification docs.
• Review qualification protocols and periodic requalification.
• Perform risk assessments on product quality, safety, and regulatory impact.
• Support supplier qualification and requalification activities with audits.
• Maintain the Approved Supplier List (ASL) in the EDMS.
• Collaborate with suppliers to resolve quality issues and non-conformances.
• Review supplier change notifications and assess potential impact.
• Initiate and manage raw material-related change controls.
• Manage SCARs, deviations, CAPAs, and root-cause analysis for material issues.
• Provide QA oversight during onboarding and lifecycle management of materials.
• Collect and review supplier documents such as CoAs, CoCs, and compliance statements.

Skills

Quality Assurance

GMP-regulated

Regulatory knowledge

Supplier quality

Documentation control

Education

Bachelor’s degree in Science

Tools

EDMS

ERP systems

Adobe Acrobat

MS Office

SmartSheet

Job description

Carex Consulting Group, partnering with a Pharmaceuticals industry partner, seeks a Quality Assurance professional to support the raw materials program in a GMP environment. You will contribute to supplier qualification, material risk assessment, specification development, and change control.

This is a key Supplier Quality role requiring a science degree and 5+ years in GMP QA, with experience in raw material release, EDMS/ERP systems, and regulatory expectations.