Compliance Investigator

HIRING NOW!

Shift: Monday to Friday 1st shift

Job Description:

• Writing and completing investigations and deviations
• complete investigations and deviations from a compliance and operations side
• Review investigation and deviation to check for manufacturing and GMP compliance
• Root cause analysis
• Fully life cycle of an investigation- will need to open and close independently
• technical writing
• interviewing manufacturing for the investigations- will need good communication
• Will be speaking with vendors on investigations

Additional Skills & Qualifications:

• Bachelor of Science in a Quality / Process related field.

• 3 years of experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma. (required)

• 3 years of experience with root cause analysis experience in pharmaceutical or FDA regulated operation preferred. (required)

• Experience using e-Quality Management Systems preferred.

• Relevant IT skills (able to work with Visio, Microsoft Project and Excel)

Experience Level:

Expert Level