Senior QA Specialist – GMP Compliance & Client Liaison

Bora Pharmaceuticals; Maple Grove (MN); On-site; USD 88,000 - 125,000; Full time

Job summary

Bora Pharmaceuticals is seeking a Senior Product Quality Specialist to provide independent quality oversight of manufacturing operations, ensuring cGMP compliance and high-quality product delivery for multiple client projects. You will lead complex quality activities, review investigations, and support audits while maintaining strong client relationships.

This senior role requires expert QA knowledge, robust documentation review skills, and the ability to mentor junior staff in a fast-paced

Qualifications

• Bachelor's degree required.
• 6 years of direct pharmaceutical/GMP experience with 2+ years in QA/QC.
• Strong knowledge of cGMP and quality systems.
• Excellent written and verbal communication; able to work independently.

Responsibilities

• Review and approve complex GMP documentation (SOPs, validation, change controls).
• Lead major-risk investigations, CAPAs, and deviations; support investigations.
• Support audits and provide QA leadership to cross-functional teams.
• Mentor junior QA personnel and ensure regulatory compliance.

Skills

Quality Assurance

cGMP knowledge

Technical writing

Analytical thinking

Communication skills

Education

Bachelor's degree

Tools

SAP

Veeva

Microsoft Office

Job description

Bora Pharmaceuticals is seeking a Senior Product Quality Specialist to provide independent quality oversight of manufacturing operations, ensuring cGMP compliance and high-quality product delivery for multiple client projects. You will lead complex quality activities, review investigations, and support audits while maintaining strong client relationships.

This senior role requires expert QA knowledge, robust documentation review skills, and the ability to mentor junior staff in a fast-paced