Process Validation Coordinator

DESCRIPTION:
The primary focus of this position is to provide sample management and associated logistical support during a drug substance process validation campaign.

KEY RESPONSIBILITIES:

- Create and maintain master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign
- Maintain and enforce sample management workflow and processes
- 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
- 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
- Daily coordination with manufacturing to confirm that sampling plan and requirements are understood and followed
- Daily check-in with laboratories and sample requestor on the receipt of samples
- Escalation and coordinate resolution of sampling related issue including but not limited to missed sample, production plan changes, sample plan changes
- Query and collate laboratory results from submitted samples; provide data verification and documentation support to summarize laboratory results in validation and technical reports
- Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign
- Validation of Drug Substance
- Will be responsible for sample preparation and management
- Will interact with cross functional teams

SKILLS:

REQUIRED SKILLS:

- Proficiency in Microsoft Word and Excel
- Prior working experience with electronic laboratory information management system (LIMS)
- Biopharmaceutical
- Documentum
- Biotech experience
- Experience in QC labs
- Experience with electronic data systems (lab systems)

PREFERRED SKILLS AND EXPERIENCE:

- Working experience with Documentum system
- Prior experience with biologics drug substance manufacturing, quality control, and/or validation
- 1-3 years experience preferred