QA Specialist – cGMP Audits & Compliance (Albany)

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

Benefits offered by this job

Competitive pay ($24-$25/hr)

Full-time schedule

Opportunity with Selectemp

On-site in Albany

Job summary

Selectemp is hiring a Quality Assurance Specialist for our Albany, OR location. The role focuses on upholding cGMP standards, reviewing records, performing internal audits, and supporting quality system improvements in a regulated manufacturing setting.

You will collaborate with cross-functional teams to maintain compliance and drive quality initiatives. The position is on-site in Albany with a full-time schedule, Monday–Friday, start ASAP.

Qualifications

• Working knowledge of cGMP and quality management systems.
• Experience with documentation and batch record review.
• Experience conducting internal audits and evaluating vendors.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Support manufacturing operations while understanding company processes and procedures.
• Conduct routine internal facility audits using structured templates and close findings.
• Review batch production records (BPR), approve quality and manufacturing records, create Certificates of Analysis, and disposition materials.
• Evaluate suppliers by reviewing questionnaires, quality agreements, and vendor qualification documentation.
• Support deviations, CAPAs, change controls, and risk assessments (FMEA).
• Assist with validation/qualification protocols and summarize results in final reports.
• Assist with document control and training within the eQMS and contribute to continuous improvement.

Skills

cGMP knowledge

Quality management systems

Batch record review

Internal audits

Vendor evaluation

Job description

Selectemp is hiring a Quality Assurance Specialist for our Albany, OR location. The role focuses on upholding cGMP standards, reviewing records, performing internal audits, and supporting quality system improvements in a regulated manufacturing setting.

You will collaborate with cross-functional teams to maintain compliance and drive quality initiatives. The position is on-site in Albany with a full-time schedule, Monday–Friday, start ASAP.