Job title: Quality Assurance Associate 

Department: Quality

Supervisor: QA Supervisor

Quality Assurance Associate will assist with establishing, implementing, and maintaining an effective quality system. Ensure that purchased and manufactured material consistently meets design, QA, and manufacturing requirements and meets regulatory compliance with FDA, ISO, and IVD Regulation. Responsible for handling quality events such as customer complaints, reworks, nonconformances, and CAPAs along with maintaining proper documentation practices to ensure compliance with FDA, ISO, and other regulatory requirements as applicable.

Duties and Responsibilities

Work with a cross-functional team to ensure all documents are properly stored and archived.

Aid in the periodic review of documents and subsequent change order process, to comply with internal QMS requirements.

Manage intake and closure of Customer Complaints using electronic QMS system.

Performs reworks, as required, and completes all necessary documentation following Good Documentation Practices.

Support with document requests during Internal and External audits. 

Support with Quality related events such nonconformances and CAPAs using electronic QMS system.

Assist with the review of batch record documents.

Perform review of raw material and finished goods incoming inspection paperwork.

Assist with Quality-related training events and provide technical expertise as needed.

Assist with maintaining equipment calibration logs and temperature monitoring.

Provide a safe work environment that complies with all local, state, and federal regulations.

Assist in other duties as assigned by the QA Supervisor.

Qualifications

Relevant bachelor’s degree required.

Previous experience GMP experience preferred, but not required. 

Be able to work with a cross-functional team on an international stage.

Be able to communicate effectively in written and spoken English

Proficient in computer programs such as Microsoft Word, Excel, and PowerPoint.

Be able to troubleshoot as necessary.

Be able to prioritize tasks effectively.

Show initiative and be proactive in their day-to-day tasks.

Preference for bilingual individuals who speak and write Chinese or Spanish.