Job Details |
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| Quality Associate/Data Entry | |
| Job ID: | 00004K2V |
| Category: | Quality Control |
| Location: | CA Camarillo |
| Hours: | 40 Monday to Friday 8am to 5pm |
| Pay: | $21.00 $24.00 |
| Quality AssocaiteData Entry Needed in Camarillo | |
| Job Description Will oversee the management of GMP documentation for area of operations and associated processes, including real time design review, approval and archiving. Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements, with a focus on raw material specification development and validation guide. Gather, rename, and upload supplier documentation SDS, RIO, VAL, TSE, REA, ROH, SLS, ENL, SPC, etc. to Ithos for each material part number, following document naming conventions and sourcing from Syteline. Create and edit raw material entries in the Ithos system, accurately populating all required in accordance with company procedures. Enter and save all raw material specification attributes across all sections inIthos, ensuring accuracy and section-by-section review prior to saving. Build and maintain validation guides Product Information FilesFormulas in Ithos for final and in-process assemblies, including creating formula entries, updating composition from drawing and BOM, and setting shelf life and storage conditions. Cross-reference assembly drawings and BOMs via Syteline to identify all raw material components to be included in validation guides, resolving discrepancies using the Engineering Workbench. Maintain complete and accurate raw material specification records in QT9 and Ithos, ensuring documentation is current revised within five years and all required document types are uploaded, reviewed, and archived per company procedures. Collaborate with Engineering and Supply chain teams to ensure drawings, BOMs, and raw material specifications are available and aligned in Ithos prior to validation guide creation coordinate corrections or missing documentation as needed. Ensures documents are entered in the quality databases, scanning, indexing, filing and archiving. Verify part number descriptions and formats using Syteline Where Used Report and Item Form to ensure consistency between Ithos entries and ERP system recor | |
| Skills Required Prior exp in data entry, data validation or quality assurance. Exp with technical documentation. Ability to follow detailed SOPs, training and documentation practices. Proficient in Excel. Solid organizational and planning skills. | |
| Skills Preferred Understanding of global pharmaceutical product regulations. Exp with ISO 9001 or 134852003. Exp working in biopharma or life sciences a plus. | |