Job Description

COMPANY SUMMARY:

RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We\xe2\x80\x99re building a robust, dynamic, and diverse network of manufacturing capability and talent \xe2\x80\x93 investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next-generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that\xe2\x80\x99s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:

The position is accountable to address QA activities as assigned by the Manager, Quality Operations relating to clinical and commercial manufacturing, and related issues which directly or indirectly impact product quality. Areas of responsibility include QA oversight of GMP areas, batch record review, investigations, and product disposition. Responsible for ensuring GMP compliance in line with US FDA, Health Canada, EU requirements, and other regulatory bodies and standards. This is a fixed -term contract position with an expected end date of 12/31/2024.

MAJOR RESPONSIBILITIES:

Production Support

• Be present in the Manufacturing and Fill Finish areas and provide on the floor support to production and perform Aseptic Filling/ Manufacturing surveillance and Quality Oversight of GMP activities as required by approved procedures.
• Perform checks or audits on production activities to ensure all work is performed in full compliance with GMP, SOP and related regulatory requirements.
• Perform immediate assessment of impact and criticality of all events and make decision to continue or stop production activities.
• Support Validation group and provide Media fill support.
• Perform document review on the floor as required e.g. logbooks, work orders, spot check review of batch record
• Perform Room Release / Change-Over Approval / Line Clearance as required by production in a timely manner.
• Perform Visual inspectors\' qualification and AQL Inspection as per approved procedures.
• Verify batch documents prior to issuance to Production.
• Attend Batch Readiness and Scheduling Meetings.
• Assist with post-shutdown activities and room release.

Investigation Support

• Assist with the investigation of deviations/non-conformances by providing guidance and support to in root cause determination and reviewing the impact and criticality of the event with respect to product function, quality, effectiveness, safety, reliability, and customer satisfaction.
• Evaluate the appropriateness of the CAPA identified to address the root cause of the issue.
• Perform Quality and Compliance impact assessment of the event on products and processes.
• Review investigations for thoroughness and completeness and approve investigation reports in Trackwise or on paper.
• Perform trending of incidents and prepare monthly report for presentation to Senior Management during Quality Metrics/Quality Council Meetings.

Batch Review and Product Disposition

• Review and approve Master Batch Documents (Batch Production Records (BPR), Buffer/Solution forms, and other documentation associated to batch manufacturing).
• Review executed batch records (BPR, Buffer/Solution forms, and other documentation associated to batch manufacturing), including equipment print outs, temperature charts, etc.
• Proactively perform follow up on outstanding issues to ensure timely batch disposition.
• Effectively disposition (release or reject) a batch ensuring compliance with regulatory and internal requirements.
• Generate and approve RESILIENCE Certificate of Compliance.

Other Activities

• Perform deviation/non-conformance investigations, as required.
• Interface with client, 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 the 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.

ADDITIONAL RESPONSIBILITIES:

• Perform all other job-related duties as assigned by Manager, Quality Operations from time to time.

MINIMUM QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

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

ADDITIONAL REQUIREMENTS:

• Pre-employment medical and medical re-examination; inclusive of eye examination and colour 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 behavioural 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 job profile provides an overview of the minimum requirements of the job and does not include all 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 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 annualized base pay hiring range for this position is $77,000.00 - $97,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate\xe2\x80\x99s 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.

National Resilience