QC Systems Specialist 1
Bend, OR
QC Systems Specialist 1
Onsite QC systems work for a 6-month contract with possible extension or conversion; includes weekly pay, medical, vision, and dental. Requires a science bachelor’s, 3+ years’ relevant experience, GMP and CSV knowledge, and travel between Bend and Tumalo.
Job Title: QC Systems Specialist I
Location: 1201 NW Wall Street, Bend, OR 97703
Contract Length: 6 Months, Potential for contract extension or conversion to FTE
Pay: $45.76/hr Weekly Pay + Benefits (Medical, Vision & Dental)
Work Arrangement: Onsite – Travel between Bend and Tumalo sites is required.
Education Requirements
Interview Process
Panel interview with relevant team members and stakeholders.
Additional Requirements
#TMCA
Location: 1201 NW Wall Street, Bend, OR 97703
Contract Length: 6 Months, Potential for contract extension or conversion to FTE
Pay: $45.76/hr Weekly Pay + Benefits (Medical, Vision & Dental)
Work Arrangement: Onsite – Travel between Bend and Tumalo sites is required.
Education Requirements
- Bachelor's degree in Science or a related scientific discipline (minimum requirement).
- Advanced degrees in Science may be considered in place of the minimum work experience requirement.
- Minimum of 3 years of relevant professional experience.
- Strong knowledge of Quality Control (QC) processes and systems.
- Experience working in a GMP-regulated environment.
- Experience with computerized system validation (CSV) is highly desirable.
- Prior experience with a Laboratory Information Management System (LIMS), preferably LabVantage.
- Previous Quality Control (QC) experience.
- Experience with change management and system implementation.
- Translate User Requirements Specifications (URS) into practical system solutions in collaboration with external system integrators.
- Conduct informal User Acceptance Testing (UAT) to verify system functionality before formal testing.
- Support IT and Quality Assurance (QA) teams in delivering high-quality Functional Specifications (FS) and Design Specifications (DS) within established timelines.
- Evaluate the business criticality of Phase 2 requirements to minimize system complexity, prioritizing process improvements over unnecessary system configurations.
- Support system interface implementation involving MES, SAP, and CDS by developing and executing appropriate test cases.
- Identify critical issues, assess risks, and escalate concerns strategically when necessary.
- Coordinate with cross-functional stakeholders to ensure smooth system integration and implementation.
- Execute business test cases to verify the accuracy and functionality of system configurations.
- Ensure QC system solutions align with business requirements, quality standards, and regulatory expectations.
- Strong understanding of QC processes, including current and future global standards.
- Basic project management skills, including managing timelines, deliverables, and dependencies.
- Knowledge of GMP regulations and Computerized System Validation (CSV) requirements.
- Technical understanding and the ability to communicate effectively with IT teams and external vendors.
- Ability to review and challenge technical solutions to ensure they meet business and compliance requirements.
- Decision-Making & Courage: Ability to make and defend impactful decisions, even when they challenge established global standards.
- Strategic Thinking: Ability to balance global consistency with local business requirements and feasibility.
- Communication & Negotiation: Strong communication skills to translate business needs into technical requirements and align stakeholder priorities.
- Problem-Solving & Adaptability: Ability to assess risks quickly and identify practical solutions.
- Resilience & Persistence: Ability to drive progress despite challenges, resistance, or ambiguity.
Interview Process
Panel interview with relevant team members and stakeholders.
Additional Requirements
- Must be willing to travel between the two work locations: Bend and Tumalo, Oregon.
- Valid driver's license and reliable transportation may be required for travel between sites.
#TMCA