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 Senior Specialist, Quality Assurance (18- month fixed term contract) position is accountable to address QA activities as assigned by the Manager, Batch Disposition relating to clinical and commercial manufacturing, and related issues which directly or indirectly impact product quality. Areas of responsibility include Batch Disposition (Review and approve Master Batch Documents, Batch Production Records (BPR), Buffer/Solution forms, and other documentation associated to batch manufacturing) and quality oversight of GMP areas. Responsible for ensuring GMP compliance in line with US FDA, Health Canada, EU requirements, and other regulatory bodies and standards.

Major Responsibilities:

• Accountable for the review and approval of executed batch records (BPR, Buffer/Solution forms, and other documentation associated to batch manufacturing), including equipment print outs, temperature charts, etc.
• Receive and reconcile all the documents from production team.
• Accountable for the review and approval of Master Batch Documents (Batch Production Records (BPR), Buffer/Solution forms, and other documentation associated to batch manufacturing.
• Ensure review of all documentation associated with the manufacture, testing and control of in-process and finished product and makes the final decision on product disposition.
• Ensure rejected materials or drug product are identified, segregated, assessed, and controlled according to internal procedures.
• Review & approval of Batch Production Records related change controls.
• Review and approval of additional ancillary GMP documentation.
• Effectively disposition a batch ensuring compliance with regulatory and internal requirements.
• Perform checks or audits on production, warehouse, and quality control activities to ensure all work is performed in full compliance with GMP, SOP and related regulatory requirements.
• Provide oversight of GMP areas and shop floor support, as required.
• Collaborate and effectively communicate with internal customers, as necessary, to provide required documentation and/or resolve documentation or compliance issues.
• Assist with the GMP and procedural training program for department's new hires and current employees as required.
• Address gaps and perform revisions to departmental SOPs, forms, and processes to streamline systems and ensure compliance to GxP and related company and regulatory requirements.
• Provide proactive leadership in moving quality & compliance goals forward throughout the organization and achieving positive and value-added results.
• Perform all other job-related duties as assigned by the Manager, Batch Disposition, as required.
• 18-month fixed term contract

Minimum Qualifications

• An experience QA professional with previous experience in a pharmaceutical manufacturing environment.
• Strong knowledge of Canadian and international regulatory and quality assurance regulations (HC, FDA, EU).
• Demonstrated good judgement and analytical skills.
• Strong ability to network with senior leadership personnel.
• Advanced competency in specific computer systems and application
• Excellent problem-solving skills, communication skills.

Preferred Qualifications

• University Bachelor's degree or degree recognized as equivalent by Canadian University/ Canadian accreditation body
• Training in microbiology and /or bio/sterile manufacturing experience is an asset.

ADDITIONAL REQUIREMENTS:

• Pre-employment medical and medical re-examination; inclusive of eye examination and color blindness test, performed every 2 years will be required as per RESILIENCE'S SOPs
• This position requires vaccination for Hepatitis A and B
• Job may require occasional extended shifts

BERAVIOURAL

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

Teamwork: Working effectively and productively with others

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

Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives

Communication: Clear and succinct verbal and written communication skills

Problem Solving: Anticipating, analyzing, diagnosing and resolving problems

Flexibility: Agility in adapting to change and ability to work independently

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

Decision Making: Utilizing effective processes to make quality-based decisions

This position may also include the following conditions:
[insert options from job description template]

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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, 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 $70,000.00 - $107,500.00 per year. 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.