Job Number: 20-10069
Job Number: 20-10069
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Project Coordinator for our client in Andover, MA.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The primary focus of this position is to provide sample management and associated logistical support during a drug substance process validation campaign.
- 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 (LIMS)
- 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 sampling requirements are understood and followed, where required
- Periodic check-in with laboratories and sample requestor on the receipt of samples
- Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and 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
- Provide sample label generation support and coordination of label placement in the manufacturing batch records.
- Must have Pharma industry experience, analytical background
- Lab analyst understanding of concepts – Note: this is an office-based position, not in the lab.
- LIMS experience (LIMS experience is not mandatory, but strongly preferred.)
- Attention to detail
- Follow processes and procedures
- SOP, CGMP environment
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.