Andover, United States
over 1 year ago
Job Description: Project Coordinator III
For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial.
Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Project Coordinator in Andover, MA
Position Summary and Special Duties:
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 (LIMS) 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 sampling requirements are understood and followed, where required 6. Periodic check-in with laboratories and sample requestor on the receipt of samples 7. Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and 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 10. 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 self-managed follow processes and procedures SOP, CGMP environment
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.
Submit resumes to: email@example.com