- Work with a cross-functional team to ensure all documents are properly stored and archived
- Facilitate the periodic review of documents to comply with internal QMS requirements
- Ensure any submitted documentation meets internal quality standards
- Assist with Customer Complaints.
- Support the Internal Quality Audit program
- Manage relevant record logs for Quality Events
- Generate document control reports as required
- Assist with the review of batch records.
- Data entry and analysis.
- Perform review of inspection paperwork.
- Assist with training and provide technical expertise as needed.
- Assist with supplier quality checks
- Assist with maintaining equipment calibration and temperature logs
- Assist with maintaining proper documentation of incoming and outgoing product
- Provide a safe work environment that complies with all local, state, and federal regulations.
- Assist in other duties as assigned by the QA Manager
- Relevant bachelor's degree required
- Be able to work with a cross-functional team in an international stage
- Be able to communicate effectively in written and spoken English
- Proficient in computer programs such as Microsoft Word, Excel, PowerPoint and Spreadsheets.
- 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, Spanish, or French.
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Quality Associate - Swedesboro, United States - Healgen Scientific Limited
Description
Job Description
Job DescriptionThe 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 the FDA, ISO, and the IVD Directive. Responsible for handling quality events such as customer complaints, CAPAs, SCARs, and nonconformance, along with maintaining proper documentation practices to ensure compliance with FDA, ISO, and other regulatory requirements as applicable.
Other relevant tasks and responsibilities include:
