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Responsible for providing Quality support to Quality Operations Management. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.

Essential Duties and Responsibilities:

Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Support external assessments or audits.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.

Include the education and experience that is necessary to perform the job satisfactorily. Associate degree in business/scientific discipline and one to three years of relevant.