Quality Assurance Specialist

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

Quality Assurance Specialist - Urgently hiring in Albany! Job Title: Quality Assurance Specialist Pay: $24.00 - $25.00/hr Hours: Day Shift, Monday-Friday Start Date: ASAP Looking for a rewarding role where your attention to detail and quality standards make a real difference? This position offers a fulfilling opportunity to uphold product quality and ensure compliance with current Good Manufacturing Practices (cGMP) in a dynamic, regulated manufacturing setting. As a Quality Assurance Specialist, you will be a key member of the Quality Unit, ensuring day-to-day compliance with cGMP, company procedures, and regulatory requirements. You'll work closely with cross-functional teams to support quality system improvements, perform audits, and review records to keep operations running safely and smoothly.

What You'll Do

• Supporting manufacturing operations while maintaining and developing a deep understanding of company processes and procedures.
• Conducting routine internal facility audits using structured templates and tracking findings through to closure.
• Reviewing batch production records (BPR), approving quality and manufacturing records, creating Certificates of Analysis, and dispositioning materials as assigned.
• Evaluating suppliers by reviewing questionnaires, quality agreements, and supporting vendor qualification program documentation.
• Supporting Deviations, CAPAs, Change Controls, and risk assessments (FMEA), while assisting with contamination control and environmental monitoring programs.
• Assisting with validation and qualification protocols (process validation, IQ/OQ/PQ) and summarizing results in final reports.
• Helping implement and maintain document control and training within the eQMS while contributing to continuous improvement initiatives.

What You'll Bring

• Working knowledge of cGMP and quality management systems, with experience in documentation, batch record review, internal audits, and vendor evaluation.
• Preferred 2+ years of Quality Assurance experience in a cGMP or equivalent regulated environment, including familiarity with 21 CFR 210 and 21 CFR 211.
• Meticulous attention to detail, strong technical writing skills, and excellent cross-functional collaboration.
• Self-management abilities to prioritize and complete tasks on time in a fast-paced environment.
• Ability to don required PPE, work in a cleanroom/laboratory setting, and access reliable transportation between Oral BioTech locations.
• Physical ability to sit or stand for extended periods, bend/stoop/reach, and lift up to 25 pounds (occasionally up to 50 pounds).

Why Join Us in Albany?

• Competitive pay of $24.00 - $25.00 per hour.
• Consistent, full-time schedule in a professional manufacturing environment.
• A meaningful role where your oversight directly impacts product safety, regulatory compliance, and high-quality standards.
• A collaborative team environment through a premier placement Opportunity with Selectemp.

Location & Schedule

This position is on-site across local facilities in Albany and offers a full-time schedule, Monday through Friday.