The Quality Assurance (QA) Coordinator II is accountable to the QA Documentation Supervisor and performs the activities associated with the QA Coordinator I as well as additional responsibilities, including but not limited to, and administration of Ennov training modules, updating SOPs, metrics reporting and training of peers and new hires on documentation processes.
Primary Duties And Responsibilities
* Configuration and administration of Ennov training modules (including auditing of the training module).
* Auditing the timely and accurate closure of DCRs.
* Providing new hire orientation training on Documentation practices.
* Training Coordinators on departmental tasks.
* Acting as a department representative during internal audits and site projects as required.
* Assisting in the review and update of department SOPs.
* Assisting in executing departmental reports including SOP Review, Training Records, Time Tracking.
* Assisting in the creation and maintenance of department instructions/training documents.
* Submitting purchase orders in AX for off-site storage costs, QA supplies, audit fees, etc. and completes the receipt of orders in AX.
* Prepares and distributes all Quality Master Documents.
* Coordinates the update, routing, and proper completion of Quality documents through other departments.
* Ensures that all documents in Ennov are maintained, administered accurately, and remain current.
* Provides support for Pharma documentation as required.
* Cancels, archives, and reassigns Ennov processes as required.
* Provides training on Ennov and documentation practices to employees.
* Updates Ennov doc units in accordance with the Ennov-Doc Unit Admin policy.
* Prepares training reports via Ennov.
* Actively supports regulatory and customer audits as required.
* Follows the policy for sharing documents with outside customers.
* Maintains filing systems for control, security, and access of all master documents.
* Archives completed documents and records in accordance with the Record Retention policy.
* Reviews contents of batch records at the time of archival in accordance with the Filing, Archival and Requests for Quality Documents procedure.
* Coordinates the pick-up and drop off for archived records through the Shipping department and off-site storage facility.
* Populates the off-site storage facility system with archived records.
* Records documents signed out to requestors via the record tracking system.
* Ensures QA office supplies are stocked and prepares purchase orders.
* Scans batch records for customers as required.
* Follows Quality and regulatory requirements and ensures quality standards are met.
* Observes and supports all safety guidelines and regulations.
* Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
* Performs other related duties as required.
Basic Requirements
Education
* College Diploma in a scientific or administrative function.
Experience
* Two (2) years of experience in an administrative function.
* Experience with documentation systems, documentation software (such as ENNOV) or equivalent experience is considered an asset.
* Experience in working in a GMP environment
* Advanced computer skills, specifically in Microsoft Word.
* Records management training would be an asset.
* Excellent organizational skill with strong attention to detail.
* Excellent communication skills, both written and verbal.
* Demonstrated ability to train others
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We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.
In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.
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