Associate, QA

hace 1 mes

Ciudad de México ABBVIE A tiempo completo

Review all production batch records for the manufacture of Humira, clinical manufacturing projects and contract manufacturing projects against specifications, and authorize release of materials or product.
- Work as a liaison between the operating groups and the Document Control group to facilitate the identification, writing, reviewing, and approval of all documents to support a given project.
- Ensure GMP and operational compliance with documentation related to the production of a batch or lot of material. This is accomplished through the systematic review of all the batch-related documents. Once all the documentation has been reviewed and signed off, assemble a batch disposition package which authorizes the approval or rejection of the given batch or lot.
- Participate in project team meetings as representative for QA/Document Control group. Ensure overall GMP compliance with project through coordination of documentation, batch record review, and other means
- Review and investigate exception reports for out of specification materials or products. Work with Production and Quality Control to investigate issues, determine causes, and identify and implement corrective actions.
- Provide Quality Assurance support for a variety of projects at the site, including, but not limited to, process improvements, compliance for newly built manufacturing suites, better yields in production area, etc.
- Interact with auditors from the FDA and/or contract manufacturing companies. Respond to auditor requests for files, documentation, records, reports, etc.
- Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation, Division, and Location.
- Provide support on QA initiatives / special projects when necessary.
- Work independently and release raw materials and components based on approved specifications
- Use of discretion and independent judgment on final disposition of raw materials and component materials for use in manufacturing of biologics.
- BS in a scientific discipline, or equivalent experience
- 3+ years experience in a GMP-related field
- Working knowledge of GMPs and their documentation
- Experience with batch record review and working knowledge of batch release
- Ability to work well in a project team environment
- Good oral, written, and presentation skills
- Strong computer skills utilizing a Microsoft environment (e.g. word, excel, access, PowerPoint)

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