Quality Investigator

Job Description

The Senior Biotech Quality Investigator is responsible for conducting thorough investigations of deviations, non-conformances, and other quality-related issues within a GMP environment. The role ensures compliance with regulatory standards and internal procedures, aiming to identify root causes and implement corrective and preventive actions (CAPA). Investigations will be focused on facilities, utilities and engineering spaces

Additional Skills & Qualifications

Required Capabilities:

• Excellent analytical and problem-solving skills.
• Proficiency in technical writing and documentation.
• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a team.
• Proficient in using quality management software and tools.

Qualifications:

• Bachelor's degree in Microbiology, Biology, Engineering, or a related field.
• Minimum of 5 years of experience in a GMP-regulated environment, with a focus on microbiology, environmental monitoring, engineering controls, and maintenance.
• Proven experience in writing deviations, investigating CAPAs, and closing records.
• Strong understanding of GMP regulations and guidelines.

(Soft Skills)

• Great Communication: Ability to clearly and effectively communicate with SMEs, team members, and management.
• SME Networking: Strong networking skills to collaborate with Subject Matter Experts (SMEs) across various departments.
• Technical Writing: Exceptional technical writing skills to document investigations, CAPAs, and other quality-related records.
• Team Collaboration: Ability to work collaboratively with cross-functional teams to achieve common goals.
• Adaptability: Flexibility to adapt to changing priorities and work in a fast-paced environment.
• Critical Thinking: Strong critical thinking skills to analyze complex issues and develop effective solutions.

Job Type: Full-time

Pay: $60.00 - $75.00 per hour

Schedule:

• 8 hour shift

Work Location: In person

Salary : $60 - $75