QA System Specialist

Essential Job Responsibilities

• Oversee the administration and control of cGMP documents to ensure their accuracy, quality and integrity.
• Adhere to record retention policies, safeguarding information and retrieving data more effectively and efficiently.
• Manage and maintain document control systems and databases.
• Ensure all documents are properly stored and easily accessible.
• Cook with various departments to ensure document accuracy and completeness.
• Monitor of SOPs revision stratus.
• Review and update documents for accuracy and completeness.
• Maintain records of document requests and retrievals.
• Aid with documentation of non-conformances associated with deviations, CAPAs, investigations, customer complaints.
• Maintain consistent and documented compliance with all relevant Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.

Job Qualifications

• Must have great attendance.
• Two years’ experience in Quality Assurance or production, preferably in the pharmaceutical and/or dietary supplements industry.
• Strong organizational skills, excellent communication skills, and good attention to detail.
• Basic understanding of CFR Part 111, and CFR Part 211 and GMP.
• Must be able to read and understand English job instructions and safety requirements.