QA Specialist - On-Site Albany, cGMP & Audits

Selectemp; Albany (OR); On-site; USD 33,000 - 34,000; Full time

Benefits offered by this job

Competitive pay

Full-time schedule

Job summary

Selectemp in Albany, Oregon is seeking a Quality Assurance Specialist to uphold cGMP standards, review records, approve quality and manufacturing records, and support vendor qualification. This hands-on role ensures product quality and regulatory compliance in a fast-paced manufacturing environment.

You'll conduct routine internal facility audits, assist with deviations, CAPAs, change controls, and risk assessments, and help maintain document control and eQMS training.

Qualifications

• Working knowledge of cGMP and quality management systems with documentation, batch record review, internal audits, and vendor evaluation.
• Preferred 2+ years of QA experience in a cGMP or regulated environment with familiarity of 21 CFR 210 and 211.
• Meticulous attention to detail, strong technical writing, and cross-functional collaboration.
• Self-management to prioritize and complete tasks in a fast-paced setting.

Responsibilities

• Support manufacturing operations while understanding company processes and procedures.
• Conduct routine internal facility audits using structured templates and track findings to closure.
• Review batch production records, approve quality/manufacturing records, and disposition materials.
• Evaluate suppliers by reviewing questionnaires, quality agreements, and vendor documentation.
• Support Deviations, CAPAs, Change Controls, and risk assessments (FMEA) and environmental programs.
• Assist with validation/qualification protocols and summarize results in final reports.
• Help implement and maintain document control and training within the eQMS and drive improvement.

Skills

cGMP knowledge

Documentation

Audits

Vendor evaluation

Cross-functional collaboration

Detail-oriented

Job description

Selectemp in Albany, Oregon is seeking a Quality Assurance Specialist to uphold cGMP standards, review records, approve quality and manufacturing records, and support vendor qualification. This hands-on role ensures product quality and regulatory compliance in a fast-paced manufacturing environment.

You'll conduct routine internal facility audits, assist with deviations, CAPAs, change controls, and risk assessments, and help maintain document control and eQMS training.