Hiring now! Quality Assurance Specialist 842608

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

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.