Associate II, Quality Systems

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.

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Position Summary & Responsibilities

The position is accountable for effectively maintaining the Document Management System (eDMS) at site alongside with overseeing the site records management program. The role reports to the Manager, Quality Management Systems and also includes support to the following programs: Change Control, Deviation, CAPA, Continuous Improvement, Training, Quality Management Review (Quality Council), Annual Product Review, and Quality Metrics. This function supports the site’s cGMP compliance with government and health authority requirements, as well as meeting client expectations.

Document Control and Management

• Accountable for Document Management System (eDMS) at site – oversight of Veeva document management workflows, including issuance of BPR documents and other GMP documents to floor level.
• Managing the eDMS system at the site, involved in revision and maintenance of GMP documents (SOPs, WINs, BPRs, BOMs, etc).
• Responsible for site records management program including archiving of GMP documentation, records storage area and record destruction.
• Any tasks within the document control and management assigned by reporting Manager.
• Involved in Batch Readiness
• Maintaining periodic reviews of documents
• Prepare trends and presentations for site document control

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.

ADDITIONAL RESPONSIBILITIES:

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

MINIMUM QUALIFICATIONS:

• A seasoned professional, with previous QA experience in a pharmaceutical cGMP manufacturing environment.
• Demonstrated good judgment 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.
• Job may require occasional extended shifts

PREFERRED QUALIFICATIONS:

• University Bachelor’s degree or degree recognized as equivalent by Canadian University/ Canadian accreditation body
• Experience interfacing with regulatory authorities and proven record of successfully presenting DMS, LMS, QMS.
• Strong knowledge of Canadian and international regulatory and quality assurance regulations (HC, FDA, EU).

ADDITIONAL REQUIREMENTS:

Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as per RESILIENCE’s SOPs This position requires vaccination for Hepatitis A and B

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

Teamwork: Working effectively and productively with others

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

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

Problem Solving: Anticipating, analysing, diagnosing, and resolving problems.

Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives. Decision Making: Utilizing effective processes to make timely decisions.

Conflict resolution – Effectively broker solutions to resolve conflicts between individuals and groups

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 $60,000.00 – $78,750.00 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.