Senior Quality Systems & Investigations Specialist

Title: Senior Quality Systems & Investigations Specialist

Employment Type: Contract

Duration: 12+ Months

Shift: 2nd Shift

Status: Accepting Candidates

We are seeking an experienced Senior Quality Systems & Investigations Specialist to lead and execute quality investigations and quality-system activities within a fast-paced pharmaceutical manufacturing environment. The ideal candidate will have strong experience managing Deviations, CAPAs, Change Controls, and QC Investigations from initiation through closure.

• Own and execute quality records, including Deviations, CAPAs, Change Controls, and QC Investigations
  .
• Lead deviation triage
  , investigation planning, and event initiation.
• Conduct interviews,
  GEMBA activities, data reviews, and Root Cause Analysis (RCA).
• Lead investigations involving manufacturing, quality control, materials, facilities, and equipment
  .
• Develop and implement effective corrective and preventive actions.
• Manage CAPAs and Change Controls from initiation through closure.
• Maintain and drive quality records within an electronic Quality Management System (eQMS).
• Track investigation deliverables, milestones, timelines, and escalations using project tracking tools.
• Collaborate with cross-functional teams to identify root causes and implement sustainable solutions.
• Ensure quality records are completed accurately and within established timelines.
• Support continuous improvement initiatives in a fast-paced pharmaceutical environment.

• 10+ years of experience in engineering, project management, pharmaceutical manufacturing, quality, or a related field.
• Strong hands-on experience with Deviation Investigations, CAPA, and Change Controls
  .
• Experience conducting Root Cause Analysis (RCA) and investigation activities.
• Knowledge of GEMBA / Gemba Walk methodologies.
• Experience working with eQMS or electronic quality management systems
  .
• Experience leading cross-functional investigations.
• Strong project management, organizational, analytical, and problem-solving skills.
• Ability to manage multiple quality records, priorities, and deadlines in a fast-paced environment.
• Strong written and verbal communication skills.

• Pharmaceutical, biotechnology, or life sciences manufacturing experience.
• Experience with QC investigations and manufacturing quality systems.
• Experience with manufacturing deviations involving equipment, facilities, materials, or processes
  .
• Experience with Smartsheet or similar project/workflow management tools.
• Experience supporting continuous improvement and quality-system initiatives.

• Estimated hourly range: $65–$75/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.