Quality Engineer
1 month ago
Job Title: Quality Engineer Tank Management and Warehouse
Job Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124
Duration: 10+ Months contract with the possibility of extension
Description:
We are seeking a Quality Engineer with at least 3 years of experience to support Tank Management and Warehouse operations. This role is critical in resolving quality issues, managing discrepancies, and reviewing documentation to ensure compliance with all applicable regulations.
Main Purpose of the Position:
- Act as a key QA contact for Tank Management and Warehouse.
- Solve routine quality issues, ensuring compliance with regulations.
- Perform tasks to achieve company goals and departmental objectives.
- Provide technical review and approval of validation deliverables.
- Maintain inspection readiness of validation areas.
- Lead validation issue resolution following cGMP regulations and company standards.
- Serve as a technical leader and subject matter expert for validation studies and regulatory requirements.
- Oversee Validation, Revalidation, and Quality Risk Management projects.
- Integrate risk management programs with quality systems, including CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
Job Duties/Responsibilities:
- Serve as the Quality representative in cross-functional projects and initiatives.
- Support validation programs during regulatory inspections.
- Resolve quality issues through effective interdepartmental partnerships.
- Provide input on validation performance metrics.
- Perform Quality Assurance Reviews (QAR) for cryovessel releases.
- Conduct assessments and evaluations in the Document Management System (DMS).
- Provide QA oversight to internal and external customers.
- Review and approve validation documents for CGMP and technical content.
- Offer technical guidance on study design, sampling plans, acceptance criteria, and rationale.
- Assess and approve quality risk management documents.
- Participate in procuring new equipment to ensure compliance and efficiency.
- Review and approve Alarm Review documentation.
- Collaborate with site and corporate units on validation standards and procedures.
Qualifications/Requirements:
- B.A. or B.S. degree in Engineering or Life Science preferred.
- At least 2 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
- Basic knowledge of engineering principles and regulatory requirements.
- Familiarity with Risk Assessment Methodologies (PHA, FMEA, FTA) preferred.
- Ability to work collaboratively in cross-functional teams.
- Knowledge of EU and US cGMPs and applicable validation guidance.
- Strong decision-making skills regarding quality and technical subjects.
- Excellent written and verbal communication skills.
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