Role Overview: The Quality Specialist will author non-conformances to decrease the site backlog.
Responsibilities:
• Train on site required SOPs
• Train on use of electronic system for non-conformances
• Author non-conformances for the duration of contract
• Education: B.S. in Chemistry, Biology, Microbiology or other science related field is required
• Experience: Minimum 1-2 years of experience in authoring non-conformances in a pharmaceutical environment
Competences:
• Knowledge of cGMP, ICH, FDA guidance and regulations
• Strong computer, scientific, and organizational skills
• Strong communication (oral and written) and attention to detail
• Ability to work with minimal supervision. Self-motivated, adaptable, and have a positive attitude.
• Ability to learn new techniques quickly, perform multiple task simultaneously, keep accurate records and comply with company policies