Quality Assurance Associate

Job Description

Job Description

A successful biotech company is looking for a motivated and detail oriented Quality Assurance Associate to join our QA team.

This position is ideal for someone interested in the biotech industry, 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.

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 reviews and approval of labels.

· Reviews SPEC sheets, enters 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.

· Support the review and approval of incoming raw materials, and calibration of equipment.

· Revise Standard operating Procedures as needed.

· 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 tasks as assigned.

We require candidates to have an Associates degree in a scientific discipline or an equivalent combination of education and experience as well as a minimum of 2 years of experience working in an FDA or ISO Regulated environment. Additionally, knowledge of ISO 13485, ISO 9001, cGMP and FDA QSR and hands-on experience of the batch record review and product disposition is preferred.

On our end, we provide comprehensive medical dental and vision insurance subsidized by the employer. On top of that, we provide life insurance, long term care insurance at no cost to employees, and we match up to 5% of your 401k contributions. To ensure a good work life balance, we provide 11 company paid holidays and 3 weeks of PTO in your first year, which increases with your tenure. But most of all, you will get to work with talented, enthusiastic, and positive professionals who will make it impossible for you to have a bad day at work and support you in your success and growth. FDA QSR and hands-on experience of the batch record review and product disposition is preferred.

If you think you will excel in this position and are interested in this opportunity, we are looking forward to receiving your application and getting to know you!