Investigations Specialist (Pharmaceutical Manufacturing)

Location: Onsite in Mulgrave, Victoria, Australia

Company

hirify.global develops and manufactures pharmaceutical products focused on patient safety, product quality, and regulatory compliance.

What you will do

• Lead complex site deviation investigations, develop project plans, coordinate subject matter experts, and communicate progress and closure plans.
• Conduct root cause analyses using Six Sigma tools, including MiniTab, Fishbone, and 5 Whys.
• Define and implement effective CAPAs, change controls, and continuous improvement initiatives to reduce repeat deviations, waste, and costs.
• Engage Operations staff in safety, quality, compliance, data analysis, and Materials Usage Variance reduction initiatives.
• Mentor Operations staff on investigation methods, proactive data analysis, root cause determination, and CAPA development.
• Present investigation findings during regulatory inspections and contract customer audits, and report deviation performance metrics.

Requirements

• Bachelor’s degree in science, Pharmacy, Engineering, or a related discipline, or equivalent pharmaceutical or allied-industry experience.
• 3–5 years of experience in pharmaceutical manufacturing or Quality, including deviation investigations in a cGMP environment.
• 1–3 years of experience facilitating investigations using Six Sigma, Fishbone, and 5 Whys methodologies.
• Knowledge of cGMP, quality systems, deviation investigations, change controls, quality records, and compliance issues related to deviations or product defects.
• Strong communication, negotiation, interpersonal, leadership, project management, problem-solving, and analytical skills.
• Permanent rights to work in Australia required. Proficiency with Microsoft Office is also required.

Nice to have

• Experience in sterile manufacturing, process validation, engineering, or Quality.
• Method 1 (M1), hirify.global Human Performance, or Lean Six Sigma certification.
• Experience with MiniTab and TrackWise Quality Management System.

Culture & Benefits

• Paid parental leave, paid volunteer days, life insurance, and options to purchase additional leave.
• Health and wellness apps, flu vaccinations, and skin checks.
• Career Growth Experiences program, recognition and rewards program, and access to the hirify.global Learning Academy.
• Salary packaging and novated lease options.
• Workplace focus on diversity, equity, inclusion, colleague wellbeing, and employee resource groups.