QA Compliance Specialist III

Summary: Maintain compliance to procedures for System Investigations, Laboratory Investigations, Corrective and Preventive Actions, Metrics and Annual Product Reviews. Maintain and administer the GMP training program and curriculum, manage the customer complaint system to assure compliance with all cGMP, State and Federal Regulations.

Primary Responsibilities/Activities:

• Change order/change control assessments (Stability protocols, IOQ Protocols, Process Validations, Site Master Files, SOPs (MNF, QCU, EM, ERP, CSV), Specification Documents (Packaging components)), Stability Protocols
• Initiate, review, and close Investigations (SIRs, LIs, CAPAs, and SCARs). Track follow-up items from the investigations.
• Complete monthly metrics for training, investigations, periodic reviews, change orders/controls. Compile the bi-annual quality metrics reports.
• Perform Annual Product Reviews to include collecting data, authoring report, and drawing conclusions based upon the data collected on the continued validated state of the product.
• Review write and/or revise company SOPs as required to assure that procedures remain current.
• Manage the training program through the electronic document management system. Conduct New-hire training for all new employees. Conduct annual GMP training and other group trainings as needed.
• Manage customer complaint system, to include logging, investigating and closing complaints, communicating with third party complaint partner, review and approve 1932 reports.
• Review temperature and humidity reports for each stability chamber for each month and the annual report. Review, sign off, and maintain the records of the QC water testing results
• Administrator responsibilities for the electronic document management system.
• Complete quarterly reports (ARCOS) and year-end inventory for controlled substances.

Qualifications:

• Education: Bachelor's degree in science related field.
• Experience: Minimum of 3 years' experience in Quality Assurance or Quality Control. Pharmaceutical experience in a cGMP environment. Experience with electronic document management systems preferred.
• Physical Requirements: None