QA Associate II – GMP Quality Systems & CAPA Focus

Seranbio; Bend (OR); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Life and long-term disability

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience is seeking an experienced Quality Assurance Associate to support GMP quality systems in our Bend, Oregon facility. You will perform day-to-day QA tasks, assist in document management, training, quality events, and participate in audits and inspections.

The role emphasizes collaboration across cross-functional teams, data analysis, CAPA management, and eQMS administration. A Bachelor’s in a scientific field and 3+ years in manufacturing, quality control, or QA are preferred, with

Qualifications

• Bachelor’s degree in a scientific field required.
• 3+ years in manufacturing, quality control, or QA.
• Knowledge of GMP and FDA regulations preferred.
• Experience with document management and CAPA.
• Proficient in audits and inspections support.

Responsibilities

• Supports the implementation and continuous improvement of the company’s Quality systems.
• Assists in monitoring of Serán quality systems through trending and metrics analysis.
• Supports the management of Serán’s quality systems through program oversight and eQMS administrative functions.
• Document authorship, review, and approval of SOPs, reports, and quality records
• Oversight of investigation and CAPA program management
• Supports internal audits, client audits and regulatory inspections, as needed
• Other related duties as assigned

Skills

GMP knowledge

FDA regulations familiarity

Communication skills

Time management

Detail-oriented

Cross-functional collaboration

Analytical skills

Scientific curiosity

Laboratory data analysis

Education

Bachelor’s Degree in scientific discipline

Tools

Veeva

SAP

Job description

Serán BioScience is seeking an experienced Quality Assurance Associate to support GMP quality systems in our Bend, Oregon facility. You will perform day-to-day QA tasks, assist in document management, training, quality events, and participate in audits and inspections.

The role emphasizes collaboration across cross-functional teams, data analysis, CAPA management, and eQMS administration. A Bachelor’s in a scientific field and 3+ years in manufacturing, quality control, or QA are preferred, with