QC Systems Specialist 1

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.

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

• 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.

Work Experience

• 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.

Preferred Qualifications

• Prior experience with a Laboratory Information Management System (LIMS), preferably LabVantage.
• Previous Quality Control (QC) experience.
• Experience with change management and system implementation.

Job Responsibilities

• 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.

Technical Skills & Requirements

• 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.

Soft Skills & Competencies

• 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.

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you. We offer:

• 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)

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