Reporting to the Quality Assurance Manager ,
The Compliance Specialist II is responsible for managing the receipt, processing, monitoring and reporting of product complaints. Ensures that all product complaint investigations received are appropriately investigated and concluded by the company's complaint handling procedure. Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing processes based upon pattern and related analyses.
The Compliance Specialist II conducts and supports problem investigations (deviations), changes controls and disposition of material and finished goods in accordance with company procedures and current regulatory requirements. Will serve as a frequent inter-organizational contact and will represent the QA department on teams. Will review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary. This position interacts with manager and director levels of management in all departments in developing solutions and providing timely and accurate communication.
This position has responsibility to ensure all quality systems are in compliance. May provide guidance on issues and will ensure compliance with the product release system, including final disposition of product into the marketplace. The successful candidate will have strong competency in attention to detail; high level of customer focus; able to make quality decisions; excellent written communication, and strong technical acumen.
Bachelor's degree in chemistry, biology, pharmacy, or related field plus 7-10 years' experience in FDA regulated environment.
QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality system.
Experience in audits and regulatory inspections (FDA & others).
A comprehensive understanding of current regulatory requirements and ability to interpret them is required.
Must have the ability to analyze, interpret, generate and communicate data statistically.
Solid computer skills in Microsoft Office and Project programs.
Familiarity with ERP and Trackwise preferred.
Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
Must be able to work on a computer for extended periods of time.
Must wear safety glasses and other protective items as required.
Sitting 75% of the day; standing or walking 25%.