Quality Assurance Associate — Quality Management System

Job overview

The Quality Assurance Associate — Quality Management System role is onsite in Bend, OR. Compensation is not specified. Serán BioScience manufactures pharmaceutical products at a GMP facility, and this role supports its quality systems programs. The associate performs day-to-day quality assurance work, helping maintain and improve quality systems and the electronic Quality Management System. The work includes document and training programs, quality events, investigations, audits, and inspections to support compliant pharmaceutical manufacturing.

What you'll do

• Support implementation and continuous improvement of quality systems
• monitor systems through trending and metrics analysis
• support program oversight and eQMS administration
• author, review, and approve SOPs, reports, and quality records
• oversee investigation and CAPA program management
• support internal and client audits and regulatory inspections as needed.

What we're looking for

Skills & competencies

quality assurance associate

quality management system

gmp

eqms

pharmaceutical manufacturing

bend or

serán bioscience

capa

quality records

audits and inspections

onsite

Work arrangement

• Weekend coverage required

Benefits & perks

• More than four weeks of paid time off accrued annually
• employer retirement contributions after 90 days
• health plans with minimal employee contributions
• basic life and long-term disability coverage
• Employee Assistance Program
• pet insurance.

Why this role

The posting prefers GMP and FDA regulatory knowledge, pharmaceutical industry experience, and a bachelor's degree, preferably in a scientific discipline; it requires three or more years of manufacturing, quality control, or quality assurance experience.

About the employer

Serán BioScience is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.