Job Purpose: Maintains quality compliance by identifying quality requirements; disseminating standards, policies, and procedures; conducting audits; recommending improvement plans.

Duties:

* Communicates quality goals and requirements by preparing and disseminating standards, metrics, standard operating procedure (SOP) management, and contractor document and production records guidelines.

* Assesses quality compliance by conducting audits; analyzing and verifying documentation; reviewing process changes.

* Prepares quality assurance reports by collecting, analyzing, and summarizing data and trends.

* Protects organization's competitiveness by keeping information confidential.

* Updates job knowledge by reviewing changes in good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory requirements; participating in educational opportunities; reading professional publications.

*Knowledge of FDA laws, regulations & practices including Quality System Regulations (QSR)

Skills/Qualifications:Quality Management, GCP, Documentation Skills, Reporting Skills, Analyzing Information, Problem Solving, Process Improvement, Verbal Communication, Informing Others, Attention to Detail.

**The qualified candidate will possess a B.S. or M.S. in life sciences with at least two (2) years experience in Quality Assurance.