QA Specialist

This is a long term contract position located in central NJ. This person will be responsible for providing support for COQA Quality Systems including (but not limited to) complaints, annual product record reviews, training, stability, quality agreements, change control and document management. Continuous assessment and maintenance of Quality Systems and SOPs will be expected in parallel w/ongoing implementation of enhancements to support COQA quality systems, policies and practices.

Responsible for supporting document control activities, to include: archival and retrieval of all controlled documents as well as maintaining the document storage systems. Work w/collaborating partners to provide documentation for contract-manufactured products. Issuance and management of correspondence to contract manufacturers.

Obtaining metrics data and communicating to management on a periodic basis. Assist in development and maintenance of various IT systems and computer applications (e.g. MS Access databases, spreadsheets and reports) used for departmental applications. Responsible for management of COQA shared area and WebSite. Manage occasional projects associates w/quality oversight of contract-manufactured products.

Minimum of a Bachelors Degree in an appropriate scientific discipline, such as Pharmacy, Chemistry or Biology is required. Computer skills MS Word, Excel and internet browsers also required. Knowledge of Microsoft Access and Documentum is desired.



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