Compliance Specialist (Fixed Term Contract)

Resilience • Mississauga, ON

18d • $24 - $33

About The Position

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.

Nice To Haves

• University degree or equivalent in science
• 1-3 years pharmaceutical experience in manufacturing, quality, or compliance
• Knowledge of GMP guidelines, Health Canada, FDA, EMA
• Previous experience in a Quality function
• 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

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 CCs, DCCs, CAPAs, SOPs, logbooks, MCCPs.
• Review 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 on the floor.
• Review and assess alarms for manufacturing areas as per procedure.
• Provide proactive leadership in quality & compliance goals forward within the department to assist in maintaining 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.

Benefits

• 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, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level