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Specialist – Manufacturing Label and Issuance
| Company | Bristol Myers Squibb |
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| Location | Bothell, WA, USA |
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| Salary | $70640 – $85600 |
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| Type | Full-Time |
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| Degrees | |
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| Experience Level | Junior |
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Requirements
- Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment
- Some document management experience
- Strong communication and customer service skills
- Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Document Management System
- Develop and improve label issuance processes to drive operational efficiency
- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively
- Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
- Possess project management skills
- Knowledge of cGMPs and domestic regulatory requirements
Responsibilities
- Issuing production labels, batch records, and other controlled documents to support manufacturing operations
- Coordination of work activities to support manufacturing
- Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and document change requests
- Assist with cross-training of Manufacturing personnel and customers to ensure adherence with procedures
- Execute the process and procedures for identifying and distributing controlled documents for the site
- Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections
- Managing an electronic document system for the Bothell site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state
- May write and revise Manufacturing Label and Issuance procedures including participating in the development and roll-out of manufacturing label and issuance tools
- Perform Manufacturing Label and Issuance metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
Preferred Qualifications
- Experience interacting with FDA or other regulatory agencies strongly preferred
- Knowledge of cGMPs and domestic regulatory requirements
