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 Deviation Specialist will play an important role in the department by writing deviations, participating in Out of Specification analysis investigation, closing batch documentation prior to release, and communicating with internal stakeholders/SME and clients. In addition, the Specialist will act as a point of contact between the manufacturing group, QA/client QA, and regulatory agencies.

MAJOR RESPONSIBILITIES:

• Authors deviations, Investigations, Environmental Monitoring Excursion, and CAPA for Manufacturing (USP/DSP/Fill/Finish//Buffer and PST) including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and tracking batch release items to meet company targets.

• Participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation reoccurrence

• Works closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements.

• Actively participates in regulatory, client, and internal audits by compiling and providing information to department manager.

• Ensures Deviations are closed within assigned timelines to meet client demand and company targets. • Participates in data gathering and analysis for Monthly and Quarterly quality matrix as well ad departmental KPI.

• Ensure adherence to GDP, GMP, and safe practices at clinical and commercial scales.

• Implement process improvement-related changes.

• Ensure corrective and preventative actions that have been implemented are effective via Effectiveness Checks (EC)

• Provide support in ensuring batch readiness action items are completed before batch start

• Performs all other job-related duties as assigned

This is a fixed-term contract position for the next 18- months

MINIMUM QUALIFICATIONS:

• 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

PREFERRED QUALIFICATIONS:

• Diploma with 3+ years of industrial experience in pharmaceutical practices or a B.Sc.

• Demonstrate ability to perform RCA investigations and lead CAPA initiatives.

BEHAVIOURAL:

Demonstrate ability to apply the following behavioral competencies on the job:

Teamwork: Working effectively and productively with others 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, analyzing, diagnosing and resolving 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 equity, 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, flexible time off, 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.