Quality Assurance Associate II

Scorpion Therapeutics; Fall River (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics in Fall River, MA is seeking a Quality Assurance Associate II to support GMP manufacturing documentation and ensure GxP compliance. You will manage electronic document workflows, review GMP documents, and assist with audits and training.

The role requires an Associate degree with GMP experience (2+ years) or 4+ years without a degree; proficiency in MS Office and EDMS, with strong organization and prioritization skills. On-site work preferred.

Qualifications

• Associate degree with 2+ years GMP experience or 4+ years GMP experience without a degree.
• GMP documentation and GxP knowledge required.
• Proficiency in MS Office and EDMS; strong organizational skills and prioritization.

Responsibilities

• Manage electronic document workflows and format GMP documents.
• Support batch record and raw material release activities.
• Maintain labeling and inventory records.
• Write and revise SOPs; conduct documentation audits.
• Assist with training programs and internal/external GMP audits.

Skills

GxP knowledge

GMP documentation

Prioritization

Education

Associate degree

Tools

MS Office

EDMS

Job description

Quality Assurance Associate II

Supporting GMP manufacturing documentation activities to ensure compliance with GxP standards.

Responsibilities: manage electronic document workflows, review and format GMP documents, support batch record and raw material release, maintain labeling and inventory, write/revise SOPs, conduct documentation audits, and support internal and external GMP audits. Also assist with training programs and off-site storage organization.

Requirements: Associate degree with 2+ years GMP experience or 4+ years GMP experience without a degree; GMP documentation and GxP knowledge; proficiency in MS Office and EDMS; strong organizational skills and ability to prioritize.

Preferred: GMP document management experience.

High-Value: GMP manufacturing, GxP compliance, documentation, audit support, training, GMP environment.

WorkSetup: not specified, likely on-site.