Quality Assurance Systems Specialist
Bend, OR
Quality Assurance Systems Specialist
Supports commissioning, qualification, and computerized systems validation in a regulated pharmaceutical or biotechnology environment, with Monday-Friday day shift and a 6-month contract. Requires a science bachelor’s degree, 5+ years’ experience, 2 years in a quality unit, and knowledge of GxPs, 21 CFR Part 11, and Annex 11.
Job Title: Quality Assurance Systems Specialist
Pay Rate: $53.19
Work Schedule: Mondays-Fridays 8:00 AM–5:00 PM- Day Shift
Location: 1201 NW Wall Street, Bend, OR 97703
Contract: 6 Months
Position Summary
We are seeking a Quality Assurance Systems Specialist to support commissioning and qualification and computerized systems validation projects in a regulated pharmaceutical or biotechnology environment. This role helps ensure consistent validation strategies for equipment, systems, computers, and methods, while promoting a strong Data Integrity (DI) culture and awareness across the site.
Key Responsibilities
At Tailored Management, we help people get jobs and take pride in their work. To better support our employees, we offer a variety of benefit options, including:
Pay Rate: $53.19
Work Schedule: Mondays-Fridays 8:00 AM–5:00 PM- Day Shift
Location: 1201 NW Wall Street, Bend, OR 97703
Contract: 6 Months
Position Summary
We are seeking a Quality Assurance Systems Specialist to support commissioning and qualification and computerized systems validation projects in a regulated pharmaceutical or biotechnology environment. This role helps ensure consistent validation strategies for equipment, systems, computers, and methods, while promoting a strong Data Integrity (DI) culture and awareness across the site.
Key Responsibilities
- Support commissioning, qualification, and computerized systems validation projects.
- Write, execute, review, and approve validation protocols, reports, and system lifecycle documents, as required.
- Collaborate with cross-functional teams, including IT, QC, Automation, QA, and vendors, to review and approve qualifications and validations.
- Perform assessments as part of change management and risk management activities.
- Act as a subject matter expert and promote consistency in validation strategies and approaches for equipment, systems, computers, and methods.
- Support system troubleshooting and staff training, as required.
- Participate in client and regulatory inspections.
- Assist with investigations, root cause analysis, and corrective and preventive actions, as needed.
- Promote a Data Integrity (DI) culture and raise DI awareness across the site.
- Support improvement of site Data Integrity maturity as defined.
- Establish and facilitate a site DI forum with a consistent, structured agenda covering ongoing DI activities (including remediation CAPAs and training), global best practices and updates, site best practices and case studies, deviations with potential DI impact, and ad hoc topics such as inspection preparation.
- Establish regular DI GEMBA walkthroughs.
- Generate, review, and approve controlled documents and records.
- Supervise validation activities and advise on courses of action for problem resolution.
- Work with stakeholders to resolve findings and gap assessments and reduce potential Data Integrity risks
- Bachelor’s Degree in Science
- Minimum of five years of experience in the pharmaceutical, biotechnology, or related industry, including two years in a quality unit.
- Experience with equipment and analytical instrument qualification and computerized systems validation.
- Working knowledge of GxPs, regulations such as 21 CFR Part 11 and Annex 11, and related industry standards (e.g., USP).
- Use of personal protective equipment (PPE).
- Occasional light lifting of less than 25 pounds.
- Travel as needed.
At Tailored Management, we help people get jobs and take pride in their work. To better support our employees, we offer a variety of benefit options, including:
- Medical Coverage – HDHP, PPO, and Surest plan options
- Minimum Essential Coverage (MEC)
- Dental Insurance
- Vision Insurance
- Short-Term Disability (STD)
- Long-Term Disability (LTD)
- Life & AD&D Insurance
- Critical Illness Insurance
- Accident Insurance
- Employee Assistance Program (EAP)