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Contract Manufacturing Quality Associate
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- Contract Manufacturing Associate Job Summary Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight.
- Area of Responsibility Review of manufacturing and packaging records Review certificate of analysis and Certificate of compliance Ensure the release packages are ready prior to batch disposition Review of QMS records submitted by CMO and monitoring (e.g. change controls/deviations, quality agreements but not limited to) Manage and oversee complaint, change control, and variation-filing modules for CMO activity.
- Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs∯*∯ Manage and oversee complaint module for Ohm Site. Work Conditions: Office Environment Lab Environment Manufacturing Environment Environmental related to manufacturing/production environments: Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
- Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
- Certified Quality Auditor (e.g. ASQ) certification preferred.
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