Quality Assurance Specialist – Pharma & Biotech
Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
Location: Bend, Oregon, USA
Industry: Pharmaceutical Manufacturing | Biotechnology
Salary: $45–$50 per hour
Work Arrangement: Primarily On-site (up to 20% remote flexibility, subject to approval)
Employment Type: Contract / Contingent
About the Role
An opportunity is available for an experienced Quality Assurance Specialist to support data integrity, computerized systems validation (CSV), and regulatory compliance within a biopharmaceutical manufacturing environment.
This position will focus on strengthening site-wide quality systems, overseeing validation activities, and ensuring compliance with pharmaceutical industry standards.
The role involves close collaboration with Quality Assurance, Quality Control, IT, Automation, and external technical partners.
Key Responsibilities
- Lead site-wide Data Integrity (DI) initiatives, governance, and continuous improvement activities.
- Oversee computerized systems validation (CSV), equipment qualification, and laboratory instrument validation.
- Develop, review, and approve validation protocols, reports, and lifecycle documentation.
- Ensure compliance with GxP requirements, 21 CFR Part 11, Annex 11, and applicable USP standards.
- Collaborate with IT, QA, QC, Automation, and external vendors on qualification and validation projects.
- Support regulatory inspections and client audits as a subject matter expert in data integrity and validation.
- Conduct risk assessments, gap analyses, and quality investigations.
- Support deviation management, root cause analysis, and corrective and preventive actions (CAPA).
- Facilitate data integrity meetings, site walkthroughs, and compliance improvement initiatives.
- Provide guidance and training to operational teams on quality and regulatory requirements.
Required Qualifications & Experience
- Bachelor's degree in a scientific discipline.
- Minimum 5 years of experience within the pharmaceutical or biotechnology industry.
- At least 2 years of experience within a Quality Unit.
- Demonstrated experience with computerized systems validation (CSV).
- Experience in equipment qualification and analytical instrument validation.
- Strong understanding of GxP regulations, 21 CFR Part 11, Annex 11, and relevant USP standards.
- Experience conducting quality risk assessments, investigations, and gap analyses.
- Strong knowledge of quality management systems and regulatory compliance.
- Excellent communication, collaboration, and stakeholder management skills.
- Ability to lead cross-functional quality and data integrity initiatives.
Compensation & Benefits
- Hourly rate: $45–$50, depending on qualifications and experience.
- Opportunities to contribute to quality and compliance initiatives within biopharmaceutical manufacturing.
- Limited remote working flexibility, subject to operational requirements.
Additional Information
This is a site-based contingent opportunity requiring regular on-site collaboration in Bend, Oregon. xhqgsiq
Remote working may be permitted for up to 20% of working time, subject to case-by-case approval and business requirements.
Quality Assurance Systems Specialist in bend at Unknown Company
This position is listed as contract and able to be worked remotely.