Description
Summary:The primary focus of this position is to provide sample management and associated logistical support during a drug substance process validation campaign.
Key responsibilities include the following:
1. Create and maintain master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign
2. Maintain and enforce sample management workflow and processes
3. Provide data verification and documentation support to ensure alignment of the master sample plan with GMP documentation such as protocols and batch records, and laboratory information system
4. Support ad-hoc, supplemental sample requests utilizing a paper-based or electronic sample request workflow; coordinate with sample requestor and manufacturing on ad-hoc/supplemental sample requests
5. Daily coordination with manufacturing to confirm that sampling plan and requirements are understood and followed
6. Daily check-in with laboratories and sample requestor on the receipt of samples
7. Escalation and coordinate resolution of sampling related issue including but not limited to missed sample, production plan changes, sample plan changes
8. Query and collate laboratory results from submitted samples; provide data verification and documentation support to summarize laboratory results in validation and technical reports.
9. Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign
Skills:
- Required Skills: Proficiency in Microsoft Word and Excel; prior working experience with electronic laboratory information management system (LIMS)
- Preferred skills and experience: Working experience with Documentum system; prior experience with biologics drug substance manufacturing, quality control, and/or validation
- Communication Skills, MS Excel Intermediate, MS Excel Intermediate, Manufacturing Process