QA Compliance, Associate

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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JOB SUMMARY:
The position is accountable for ensuring site's cGMP compliance with government and health authority requirements, as well as meeting client expectations. The main responsibility of this role includes document control and management and managing the training program. It also includes, Quality Management Review, Annual Product Review and New Material Enrollment, Supplier maintenance activities, and supporting the Quality Management Systems (QMS): Change Control, Deviation, CAPA, Continuous Improvement.

MAJOR RESPONSIBILITIES:
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
• Responsible for site records management program including archiving of GMP documentation, records storage area and record destruction.
• Maintaining periodic reviews of documents
• Prepare trends and presentations for site document control

Training

• Develops user requirements and contributes to the configuration, validation, implementation, and lifecycle management of the GMP Learning Management System (eLMS).
• Collaborates with management to develop and manage personnel training plans in alignment with learning objectives and employees' functional roles.
• Coordinates, schedules, and conducts New Hire Introduction to GxP course while supporting other new hire orientation activities.
• Assists functional areas in developing on-the-job (OJT) training evaluations, instructor- led courses, and course skill quizzes and/or evaluations.
• Manages and maintains training curricula, training records and monitors training/re-training requirements using the Veeva Vault Training eLMS.
• Contributes to site Quality Management Reviews (QMR) to assess the health of the local GMP training program; identifies unfavorable trends and collaborates with Quality and other GMP departments to ensure their timely mitigation.
• Provides support in the preparation for, the conduct of, and follow-up activities associated with regulatory inspections and client audits.
• Develops custom Vault Training reports as needed for internal clients.

Other Activities

• Support the Inspection Readiness Program and Site health for all Quality Systems
• 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.
• Perform all other job-related duties as assigned by Manager, QA Compliance from time to time.

MINIMUM QUALIFICATIONS:

• Previous QA experience in a sterile pharmaceutical manufacturing environment.
• Advanced competency in computer systems and application
• Demonstrated good judgement and analytical skills
• Strong knowledge of Canadian and international regulatory and quality assurance regulations (HC, FDA, EU).
• Excellent problem-solving skills, communication skills.
• Experience interfacing with regulatory authorities

PREFERRED QUALIFICATIONS:

• University Bachelor's degree or degree recognized as equivalent by Canadian University/ Canadian accreditation body
• Strong ability to network with senior leadership personnel

ADDITIONAL REQUIREMENTS:

• Job may require occasional extended shifts.

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 $50, $68,750.00 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.