Resilience

Specialist, Deviations (Fixed Term Contract)

CAN - ON - Mississauga - Meadowpine Blvd · Contract

Sponsorship not specified$24k-$33kDetected 10 days ago

AccessibilityGMPFDA RegulatoryCommunicationCollaborationProblem Solving

About the role

The Deviations Specialist will play an important role in the department by unblocking, investigating and authoring deviation reports.
Deviation Specialists also participate in Out of Specification analysis investigations, closing batch documentation prior to release and communicating with internal stakeholders/SME and Client.
In addition, the Specialist will act as a point of contact between the Manufacturing group, QA, Client and regulatory agencies.

Effectively and efficiently write deviation investigations. Develop an investigation strategy, perform Root Cause Analysis by selecting appropriate analytical tools, collect and analyse data to determine root cause
In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause
Performs all other job-related duties as assigned

Ability to work with minimal supervision
Prepare operations investigations to support other functional areas as required, performed the deviation review process and ensure deviation investigations close according to targeted timelines
High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job.

Diploma with 3+ years or a B.Sc. with relevant industrial experience in pharmaceutical practices.
Demonstrate ability to review manufacturing, engineering, and quality documentation.
Experience in top-tier biopharmaceutical environment
Knowledge of regulatory agencies HC, FDA and others.
Strong working knowledge GMP requirements.
Demonstrate ability to apply the following behavioural competencies on the job:
Teamwork: Working effectively and productively with others, delegates tasks and works with all members of the team to ensure timelines are met
Independence: Ability to work with minimal supervision

Diligence: Attention to detail.
The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.
Requests for accommodation can be made at any stage of the recruitment process.
Applicants are asked to make their needs/requirements known to Human Resources.
Our target base pay hiring range for this position is $24.00 - $33.00 per hour.
Excited about Resilience?

Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fert

A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made.
We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com

This listing is sourced directly from Resilience's careers page and normalized into a canonical job model.