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Laboratory Management System Program Coordinator
1 month ago
BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.
We are seeking a highly skilled Laboratory Management System Program Coordinator to join our team. The successful candidate will be responsible for:
- Configuring the NuGenesis Laboratory Management System (LMS) to meet the needs of end users.
- Preparing project plans and test protocols, and leading assigned project teams.
- Leading incident investigations and change management to ensure continuous improvement.
- Developing and overseeing the maintenance program throughout the LMS's lifecycle.
- Participating in internal and external audits as the SME for the LMS.
- Reviewing and approving all activities related to the installation, implementation, and optimization of the LMS.
- Assessing, proposing, and implementing future enhancements to the LMS implementation with BIOVECTRA.
- Reviewing and initiating revisions to Standard Operating Procedures governing LMS.
- Participating in the validation and qualification protocols, activities, audits, and reports related to the LMS.
- Ensuring validation and maintenance of the LMS is compliant with the GMP regulation(s) such as 21 CFR Part 11.
- Providing training on the electronic systems including power users on higher-level development activities which will be required for the application's long-term use.
The ideal candidate will have:
- Post-Secondary education.
- Bachelor's degree in a scientific or computer science field is an asset.
- Minimum 2 years of previous work experience in a pharmaceutical quality management system.
- Experience in Quality Assurance and/or Project Management considered an asset.
- Ability to work independently with minimal supervision, as well as part of a team.
- Excellent organizational skills and the ability to multi-task and interchange from projects.
- Excellent computer skills including EXCEL, Word, and MS Project.
- Strong written and oral communications skills are necessary, as this position requires interaction with various levels of management, as well as interaction with external technical support teams.
- Must be prepared to travel between Nova Scotia and PEI sites on a frequent basis for training and support.
- Must be prepared to work out of hours on occasions to support system and operations.
BIOVECTRA offers a competitive salary and benefit package. Interested candidates are encouraged to apply.
