GMP QA Specialist – Elevate Clinical Manufacturing Quality

Serán BioScience; Bend (OR); On-site; USD 75,000 - 110,000; Full time

Job summary

Serán BioScience in Bend, Oregon is seeking a Quality Assurance Specialist to support GMP clinical manufacturing operations, reviewing and approving records, investigations, CAPA, and change controls while providing floor support and driving quality improvements.

The ideal candidate holds a Bachelor’s degree in a scientific discipline and 3+ years of GMP QA experience, with strong documentation, communication, and cross‑functional collaboration skills.

Qualifications

• Bachelor’s degree in a scientific discipline preferred.
• 3+ years GMP manufacturing or QA experience.

Responsibilities

• Implementation and continuous improvement of the company’s quality systems.
• Documents authorship, review, and approval of SOPs and associated documents.
• Reviews/approves master batch records
• Raw material and product review and release.
• Oversight, review, and approval of investigations, CAPA, and change controls.
• Contributes to a culture of quality ownership, compliance, and continuous improvement.
• Communicates quality-related information to internal team with guidance and recommendations.
• Supports internal audits, client audits and regulatory inspections, as needed.
• All other duties as assigned.

Skills

GMP knowledge

Change control

CAPA

Investigations

Documentation practices

Cross-functional collaboration

Communication

Time management

MS Office

Education

Bachelor’s degree in a scientific discipline

Job description

Serán BioScience in Bend, Oregon is seeking a Quality Assurance Specialist to support GMP clinical manufacturing operations, reviewing and approving records, investigations, CAPA, and change controls while providing floor support and driving quality improvements.

The ideal candidate holds a Bachelor’s degree in a scientific discipline and 3+ years of GMP QA experience, with strong documentation, communication, and cross‑functional collaboration skills.