Quality Assurance Specialist

Key Responsibilities:

• Lead and document deviations, investigations, and CAPAs within GMP-regulated environments, specifically supporting TOS functions.
• Act as the primary Quality representative for CMRs (Change Management Requests) and TrackWise investigations.
• Provide technical writing support for detailed investigations and root cause analyses (e.g., 5 Whys, Fishbone diagrams).
• Collaborate with operations to assess GMP issues and determine appropriate quality actions.
• Challenge existing processes and contribute to continuous improvement initiatives (e.g., 5S).
• Maintain and review GMP documentation related to instrumentation, equipment, and utilities.
• Support CMMS-related quality activities and ensure compliance with internal procedures.
• Help reduce the burden on managers by owning deviation workflows and TrackWise entries.

Qualifications:

• 3–5 years of experience in a GMP-regulated pharmaceutical or biotech environment.
• Strong working knowledge of GMP principles , documentation practices, and compliance standards.
• Experience with TrackWise or similar deviation/compliance management systems.
• Proven ability to write clear, concise, and technically sound investigations.
• Familiarity with CMMS systems and equipment/instrumentation documentation.
• Ability to work independently and partner effectively with cross-functional teams.
• Strong attention to detail and organizational skills.

Preferred Skills:

• Experience supporting technical departments such as maintenance, utilities, or instrumentation.
• Knowledge of root cause analysis tools (e.g., Fishbone, 5 Whys).
• Ability to assess and challenge processes to drive quality improvements.