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 JOB SUMMARY: The Compliance Specialist is to support the manufacturing team with achieving and maintaining a high level of cGMP compliance within the Company to meet client, regulatory agency, and RESILIENCE expectations. MAJOR RESPONSIBILITIES: Coordinate Compliance Wire training activity (SOP & technical) within Manufacturing including delivery of Compliance related training. Review of executed Batch Production Records (BPR) and ensure timely turnaround to Quality department and client. Assist with investigations (Deviations, Out-of-Specification, and Environmental Monitoring Excursions), and ensure timely closure. GMP document control which includes but 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 involving quality & compliance goals forward within the department. Maintain departmental KPIs 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. Fixed term contract for 12 months PREFERRED QUALIFICATIONS: University degree or equivalent in science 1-3 years pharmaceutical experience in manufacturing, quality, or compliance Knowledge of GMP guidelines, Health Canada, FDA, EMEA Previous experience in a Quality function BEHAVIOURAL: Demonstrate ability to apply the following behavioural competencies on the job: Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective Leadership: Achieving extraordinary business results through people Problem Solving: Anticipating, analyzing, diagnosing and resolving problems Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types Decision Making: Utilizing effective process to make decisions This 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. 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 $24.00 - $33.00 per hour. 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. Join Our Talent Community Don't see a posting that's the right fit? Join our talent community to be considered in our talent pool and we'll reach out if the right opportunity arises. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites
