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  • Quality Engineer

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    Hillsboro, United States HIS Innovations Full time

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  • Quality Manager

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    Hillsboro, United States Gxo Full time

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  • Hillsboro, United States Tailored Management Full time

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6821 Quality Engineer Tank Management and Warehouse

1 month ago


Hillsboro, United States Harvest Technical Services Full time

Onsite:Main Purpose of the Position:Directly support Tank Management and Warehouse by acting as a key QA contact for issue resolution, discrepancy management, and documentation review.Solve routine quality issues limited in scope and complexity following all applicable regulations.Perform assigned tasks and work to achieve company goals and department objectives.Provide technical review and approve validation deliverables ensuring proper study design and execution.Maintain the compliance status of the assigned validation areas at a state of inspection readiness.Working with multiple functions, lead solution of validation issues following cGMP regulations and company standards.Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design and regulatory requirements.Provide Quality Assurance oversight to Validation, Revalidation and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.Provide technical review and approve validation deliverables ensuring proper study design and execution.Maintain the compliance status of the assigned validation areas at a state of inspection readiness.Job Duties/Responsibilities:Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.Support the validation program during regulatory agency inspections.Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.Be accountable for behaviors as described in the company's Competencies. Provide input into the design and presentation of validation performance metrics. Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones and schedules.Technical Duties/Responsibilities:Perform QAR's for cryovessel release(s)Perform assessor and evaluation activities in DMSInteract with inter-departmental contacts on discrepancy assessment and resolutionProvide QA oversight to internal and external customersProvide Quality oversight (including technical requirements and regulatory expectations) of site validation efforts.Review and approve validation documents (e.g. Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.Provide technical guidance for study design including sampling plans, acceptance criteria and rationale.Provide technical and quality validation assessment and approval for engineering and process changes.Collaborate with departments to ensure validation activities are executed compliantly, with efficiency and effectiveness.Review, assess and approve Quality Risk management documents.Participate in the risk stages of procuring new equipment. Collaborate with departments to ensure risk management and validation activities are executed efficiently and effectively.Review and approve Alarm Review documentation.Provide input into investigations with potential validation impact.Provide input and collaborate with other site/functional units and Corporate on validation standards and procedures.Qualifications / Requirements:B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years' experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency and company requirements.Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), preferred.Ability to work collaboratively in cross-functional teams to achieve milestones and goals.Basic knowledge of EU and US CGMPs and applicable validation guidance.Ability to make sound decisions about quality and technical subjects.Ability to communicate clearly and professionally both in writing and verbally.The hiring range for this position is $42 to $52 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.#ZR