Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Investigates and observes Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product registrations are followed and maintained. Conducts investigations of batches, preps, lots, equipment, and facilities in accordance with the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA and DEA requirements.

• Support incident management review (RAPID process) to assess if a deviation is warranted, the containment measures and the path forward
• Support collecting information during RAPID process by applying 5 Why, Fishbone diagram or other incident management tools
• Conduct investigation writing and assist identifying the probable root cause of the incident
• With the guidance of Area lead and/or QPL resolves if batch is acceptable to release, or to deny release, what corrective actions are necessary and provide follow-up to ensure that corrective actions have been implemented.
• Assures review of incident by appropriate level of management
• Assist on functional area GEMBAs and GMP inspections of facilities to assure compliance with the current GMP regulations.
• Assist on housekeeping inspections
• Recommends changes to batch records for clarification and compliance.

• Minimum of 1+ years' experience in Records, Investigation Writing, QC, QA, Analytical Development, Process Engineering, Engineering services or manufacturing is required
• Bachelors Degree in Chemistry, Biology, Engineering or relevant science preferred.

• Knowledge of GMP
• Excellent problem solving and writing skills.
• Strong Proficiency in Microsoft Office Suites
• Ability to work on multiple projects simultaneously.