Job Overview
The Quality Operations Laboratory Project Specialist is responsible for ensuring all relevant QC documentation is complete and accurate.
Main Responsibilities:
* Lead and project manage multiple stakeholders to give updates on project status at required forums.
* Maintain project schedules and manage to conclusion throughout capital and validation lifecycle.
* Manage pre-requisite tasks to secure investment including liaising with stakeholders, vendors, and teams.
* Drive projects to completion by working collaboratively with all parties to implement project deliverables.
Requirements:
* Bachelor's degree in biological, chemical sciences, business, or a related technical field or equivalent experience in a regulated industry.
* Preferably 2-4 years of experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
* Proven documentation skills with the ability to generate text and write documents clearly and unambiguously.
Preferred Skills:
* Experience working with a documentation system (e.g., PDOCs) and an investigation/change control system (e.g., QTS/eQMS).
* Knowledge of paperless digital systems (e.g., Kneat); experience with validation and computer system lifecycles.
* Excellent communication and interpersonal skills, with a proven record of demonstrating agility and capability to work in a fast-paced environment.