- Title: Project Coordinator
- Code: RCI-19764-1/19756-1
- Location: Andover Massachusetts (MA) 01810
- Posted Date: 10/16/2020
- Duration: 6 Months
Talk to our Recruiter
- Name:Namy Bhatt
- Email: email@example.com
- Phone: 908-704-8843 ✖ 207
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:
- Create and maintain master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign
- Provide data verification and documentation support to ensure alignment of the master sample plan with GMP documentation such as protocols, reports, manufacturing batch records, and laboratory information system (LIMS)
- Used to processes and procedures (SOPs) in a cGMP environment
- Highly preferred Technology Transfer background with biologics manufacturing
- Must have Pharma industry experience
- Provide sample label generation support and coordination of label placement in the manufacturing batch records.
- Query and collate laboratory results from submitted samples; provide data verification and documentation support to summarize laboratory results in validation and technical reports.
- Periodic check-in with laboratories and sample requestor on the receipt of samples
- 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
- Maintain and enforce sample management workflow and processes
- Daily coordination with manufacturing to confirm that sampling plan and sampling requirements are understood and followed, where required
- Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and sample plan changes
- Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign. This can involve responsibility for campaign closure activities.
- LIMS experience (LIMS experience is not mandatory, but strongly preferred)
- Bachelor degree In science field or related discipline preferred
- An associate degree can be consider
- Understanding concept of large scale biologics manufacturing
- Strong technical writing skills a must