Specialist, Deviations (Fixed Term Contract)

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

JOB SUMMARY:

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.

MAJOR RESPONSIBILITIES:

• Responsible for identifying recurring Deviations/Non-conformances and ensure appropriate actions are taken
• Capture immediate actions and initial impact in deviation records to help ensure issues are remediated prior to proceeding with manufacturing
• 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
• Prepare operations investigations to support other functional areas as required, performed the deviation review process and ensure deviation investigations close according to targeted timelines
• Accountable for working on problems associated with a wide variety of quality issues that range from errors in production, incomplete batch records, component reconciliation, poor documentation practices etc.
• In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause
• High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
• Work with internal stakeholders, SMEs, client to review/finalize investigations prior to closure
• Ensure deviations are closed in a timely manner
• Performs all other job-related duties as assigned
• 18 Month Fixed Term Contract Position

PREFERRED QUALIFICATIONS:

 

• Diploma with 3+ years or a B.Sc. with relevant industrial experience in pharmaceutical practices.
• Demonstrate ability to perform RCA investigations and lead CAPA initiatives.
• Demonstrate ability to review manufacturing, engineering, and quality documentation.
• Strong working knowledge GMP requirements.
• Experience in top-tier biopharmaceutical environment
• Knowledge of regulatory agencies HC, FDA and others.

BEHAVIOURAL:

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

Flexibility: Agility in adapting to change

Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.

Problem Solving: Anticipating, analysing, diagnosing and assisting the team to resolve problems

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types

Diligence: Attention to detail.

 

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. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). 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.

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, fertility healthcare and family-forming benefits, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $24.00 - $33.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.