Quality Specialist - cGMP Manufacturing - Weekend 1st Shift

Responsibilities

• Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Supports for client and regulatory agency audits and inspections.
• Provides quality evaluation and release of support materials, products, equipment and facilities as required.
• Maintains quality databases and may perform analysis and trending.
• Affords assistance with quality improvement initiatives as needed.
• Develops quality SOPs or other quality documents and/or reports as needed.
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics in areas of expertise.
• Provides Quality oversight for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc.
• Effectively performs a variety of complex duties, on schedule, with accuracy and competency.
• Maintains accurate files and records.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master’s degree in relevant field and 1+ years of related experience.
• Relevant GMP experience required.
• Experience in Environmental monitoring and critical utilities preferred for sterile operations.