Tellus Solutions is in partnership with a committed biopharmaceutical company focused on providing innovative therapies. Your technical expertise as a Data Analyst II/ Document Control in the area of QA, Commercial (Marketing), Regulatory, R&D and CMOs will contribute to our client's innovative therapies which will impact the quality and duration of life.
This position works with all electronic ECR (Engineer Change Records) from creating, edit engineering documentation to support, assembly consistency, product qualification and customer satisfaction, that is related to packaging development / manufacturing of skincare in third-party facilities. This position performs duties under limited of supervision and according to company's SOP.
- Coordinate with Packaging Engineer, QA, Commercial (Marketing), Regulatory, R&D and CMOs to ensure packaging components need the capacity / fit /form / function requirements
- Work with suppliers to ensure all critical parameters are called out on the technical spec. To Create and update all tech specs and keeping track of files.
- Coordinate with suppliers and CMO to verify various testing to ensure the package meet the fit / form / functions.
- Assisting other departments and keeping communications of new product release dates.
- Create and manage ECR (Engineering Change Request) to meet Quality's approvals, PF&As (100+ SKUs) and pallet patterns. Ensure all documents are uploaded and tracked in files.
- Create, update all packaging technical specifications (1000+ Specs) & assembly instructions -ECR (PF&As).
- Request part numbers through software system.
- Create manufacturing instructions.
- Route documents for signatures electronically.
- Review current documents for completeness & robustness.
- Update and maintain current technical documentations as they relate to packaging.
- Create/manage ECR (Engineering Change Request) and load the necessary info into PAMS-AMS/SAP/ Winshuttle/TrackWise/OneVault (Veeva) data base system
- Work with Engineers in components and lab testing.
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Last updated on Nov 22, 2023