Job Description

A career at Resilience is more than just a job \xe2\x80\x93 it\xe2\x80\x99s an opportunity to change the future.Resilience is a technology-focused biomanufacturing company that\xe2\x80\x99s changing the way medicine is made. We\xe2\x80\x99re 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 visitJOB SUMMARY:The focus of this role is to support the manufacturing team in achieving and maintaining a high level of GMP compliance within the Company to meet client, regulatory agency, and RESILIENCE expectations. Review of executed Batch Production Records (BPR) and ensure timely turnaround to the Quality department and client. Assist with investigations (Deviations, Out-of-Specification, and Environmental Monitoring Excursions), and ensure timely closure.MAJOR RESPONSIBILITIES:Coordinate Compliance Wire training activity (SOP & technical) within Manufacturing including delivery of Compliance-related training.GMP document control which includes but is not limited to creation/revision/closure of CAPAs, SOPs, logbooks, MCCPs.Generate Effectiveness Checks as result of CAPA execution and ensure timely closure.Initiate Change Controls related to documents and equipment for manufacturing, ensure execution and timely closure.Assist with completing CAPA actions and ensure timely closure of CAPA records for the Manufacturing Department.Assist with addressing audit observations (internal, client, regulatory) and ensure timely closure.Conduct regular inspections during GMP batches to assess GMP and GDP compliance, and report any issues identified to management.Responsible for compliance logbook reviews.Provide proactive leadership in moving quality & compliance goals forward within the department. Maintain departmental KP!s to monitor trends for process improvement.Ensure timelines for batch start are achieved by timely request of documents required for the batch.Work closely with department staff to assist them in implementing effective risk-based GMP processes, procedures, and documentation.Perform all other job-related duties as assigned.TECHNICAL KNOWLEDGE I EXPERIENCE:University degree or equivalent in science1-3 years of pharmaceutical experience in manufacturing, quality, or compliancePREFERRED QUALIFICATIONS/ EXPERIENCE:Knowledge of cGMP guidelines, Health Canada, FDA, EMEAPrevious experience in a Quality functionBEHAVIOURAL:Demonstrate ability to apply the following behavioural competencies on the job:Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objectiveLeadership: Achieving extraordinary business results through peopleProblem Solving: Anticipating, analyzing, diagnosing and resolving problemsInterpersonal Skills: Effectively communicating, building rapport, and relating well to all personality typesDecision Making: Utilizing effective process to make decisionsThis job profile provides an overview of the minimum requirements of the job and does not include all of 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.While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).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 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 $24.00 - $33.00 per hour. 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