Senior Associate, QA Operations

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

Position Summary & Responsibilities

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.

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 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.

Minimum Qualifications

• A seasoned professional with previous 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

• University Bachelor's degree or degree recognized as equivalent by Canadian University/ Canadian accreditation body
• A minimum of 5 years of previous QA experience in a pharmaceutical manufacturing environment.
• Training in microbiology and /or bio/sterile manufacturing experience is an asset.

ADDITIONAL RESPONSIBILITIES:

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

This position may also include the following conditions:

• 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

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 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 $70,000.00 - $103,750.00 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.