Quality Assurance Associate

Position Title: QUALITY ASSURANCE ASSOCIATE

Full Time, Exempt Employee

Job Reference ID: 61310261

Location: Tigard, OR

ABOUT YECURIS CORPORATION

Yecuris is a biotechnology company specializing in industry-leading liver-humanized mouse models and research services. Our platforms enable biotech, pharmaceutical, and academic scientists to generate human-relevant insights at the cellular, tissue, and whole-animal level, and are integral to drug metabolism, infectious disease, and cell and gene therapy research – and we’re growing.

We are seeking an experienced Quality Assurance Associate to strengthen our internal quality systems, lead process improvement initiatives, and coordinate employee skills training to enhance operational efficiency, consistency, and quality.

Please note: This role does not operate within a formal GLP, GMP, or ISO compliance framework. Our quality systems are built on internal standards, client expectations, and operational excellence.

CORE RESPONSIBILITIES

Review Records and Resolve Quality Issues

• Review and approve internal records, batch documentation, study data, and operational logs for accuracy, completeness, and consistency.
• Identify, document, and help resolve quality discrepancies, deviations, and nonconformances, including routing issues to the right owner and following them through to resolution.
• Promote good documentation practices and data integrity across teams, and coach colleagues on documentation expectations.

Manage Document Control

• Maintain and optimize document control processes within the quality system, including revision control, version tracking, and archival.
• Administer change control, including routing documents for review and approval, and issuing, distributing, and retiring controlled documents.
• Maintain the master index of controlled documents and ensure current versions are available at the point of use.

Drive Corrective Action and Continuous Improvement

• Conduct internal audits and self-inspections; track corrective and preventive actions (CAPAs) to closure and verify their effectiveness.
• Support improvements to manufacturing and study processes and workflows to enhance quality and consistency.
• Track and trend quality metrics (e.g., deviations, CAPAs, audit findings) and report them to management.

Support Client Audits and External Inquiries

• Support client questionnaires and external audits, including document retrieval, facility readiness, and follow-up response tracking.
• Maintain audit-ready quality files and records so that requests from clients and auditors can be answered accurately and on time.

Build the Vendor Qualification Program

• Take a leading role in establishing a vendor qualification program, including qualification criteria, supplier documentation, and periodic re-evaluation.
• Maintain an approved vendor list and help investigate and document vendor-related quality issues.

Keep Equipment and Training Current

• Track and assist with laboratory equipment calibration and preventive maintenance, and maintain the related records.
• Establish and maintain personnel training matrices and verify that staff are current on required role-specific training.
• Support sample management, environmental health and safety (EHS), and facility readiness activities by maintaining the supporting documentation.

Elevate Technical Writing and Editing

• Edit and proofread quality system documents, including batch records, SOPs, work instructions, study reports, and client-facing technical documents, for clarity, grammar, consistency, and adherence to company style and formatting standards.
• Collaborate with subject matter experts (e.g., scientists and operations staff) to translate technical content into clear, well-organized documentation, including drafting and revising SOPs.
• Review documents for logical flow, technical accuracy, and consistency with related procedures.
• Maintain templates and style guides for internal technical writing.

Grow and Collaborate

• Stay current on best practices in quality management and technical communication.
• Participate in cross-functional projects as a quality and documentation resource.
• Perform other duties as assigned by management.

QUALIFICATIONS

Required

• Bachelor’s degree in a life science or related field
• 2+ years of experience in a quality assurance role, ideally in a life sciences, biotechnology, or laboratory setting (e.g., QA Associate or Specialist, Quality Coordinator, Document Control Specialist)
• Strong working knowledge of quality systems, including deviations, CAPAs, audits, change control, data integrity, and audit readiness; familiarity with GxP concepts is helpful but not required
• Working knowledge of document control practices, including version control, change management, and approval workflows
• Experience developing or maintaining SOPs, training materials, or technical guides
• Excellent written and verbal communication skills, with experience editing technical or scientific documents
• Self-driven team player who collaborates effectively with scientists and operations staff
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint

Preferred

• Experience in a CRO or biotech operations environment
• Familiarity with laboratory or animal research operations
• Experience supporting client audits, quality questionnaires, vendor qualification, equipment calibration tracking, personnel training matrices, sample management, EHS, or facility readiness activities

KEY SKILLS

• Positive attitude with the ability to work cooperatively in a team environment
• Highly organized and capable of meeting deadlines
• Excellent attention to detail, with the ability to identify inconsistencies across complex documents
• Strong verbal and written communication skills
• Well-developed multi-tasking skills
• Ability to work in a fast-paced environment and quickly adapt to changes
• Ability to work independently, exercise sound judgment, and manage multiple priorities
• Discretion in handling confidential and proprietary client information

WORK ENVIRONMENT

• This position is in an office setting, with access to laboratory and animal facility areas as needed for record review, inspections, and audits
• Ability to lift up to 25 lbs occasionally, with or without reasonable accommodation
• Ability to wear required personal protective equipment and follow facility entry procedures when working in laboratory and animal facility areas

EQUIPMENT

Office Equipment: personal computer (MS Office suite, document control and quality management systems, databases), printers, scanners, phones.

BENEFITS

Yecuris offers exciting career opportunities in a dynamic working environment. Full medical, dental, vision, 401K, and profit-sharing benefits provided for full-time employees. Join a collaborative, science-driven team supporting gene therapy, infectious disease, and metabolic disease research. Convenient location in Tigard, Oregon with free parking.

Pay: $56,000.00 - $76,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Ability to Commute:

• Tigard, OR 97224 (Required)

Work Location: In person