Quality Assurance Associate

A successful biotech company is looking for an experienced and detail-oriented Associate to join our Quality Assurance team on site in Bothell, WA. Unfortunately at this time no relocation or visa sponsorship provided.

At ELITechGroup, we are committed to supporting health systems globally. We take pride in our team and strive to maintain a work environment that is both professionally challenging and personally fulfilling. As a valued member of our team, you would contribute to the manufacturing and distribution of in vitro diagnostic products to clients in over 100 countries. You will have the opportunity to work alongside some of the brightest minds in the industry, as our team is dedicated to solving problems and delivering excellent products. This position is ideal for someone with some experience in the biotech industry and audits, who takes pride in learning all aspects of the job and adhering to procedures and standards. You will receive guidance from a supportive team that will ensure you are trained and capable of performing your responsibilities effectively. The primary focus of the QA Associate role is to support commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.

Summary

With direction, has part of the responsibility for ELITechGroup MDx Quality Assurance activities.

Essential Duties and Responsibilities

• Performs review of manufacturing batch records, enter information in Disposition Log, filing of batch records, and ensure the records are complete and stored in a manner where they are readily retrievable.
• Performs finished product inspection.
• Performs review and approval of labels.
• Reviews SPEC sheets, enter information in Disposition Log, file.
• Assists QA with the tracking and/or completion of CAPAs and Customer Complaints.
• Assists QA with the tracking and/or completion of NCRs, OOSs, TMPs.
• Assigns part numbers.
• Reviews, tracks, and files training forms. Ensures the training log is updated.
• Reviews calibration/maintenance records, update tracking log, file.
• Ensure the records are complete and stored in a manner where they are readily retrievable.
• Participates during audits (FDA, ISO, vendor)
• Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary.
• Other duties and task as assigned.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values.

Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure

quality. Written Communication - writes clearly and informatively; able to read and interpret written information.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor's degree (B.A. or B.S.), or equivalent combination of education and experience.
• Minimum of 2 years' experience in working in an FDA or ISO regulated environment or equivalent training.
• Knowledge of ISO 13485, ISO 9001, and FDA QSR preferred