Compliance Specialist

Job Purpose:

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

Duties:

* Identifies quality requirements by reviewing regulations, guidelines, and standards, including International Committee on Harmonisation (ICH), International Organization on Standardization (ISO), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA).

* 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.

* Improves quality compliance by recommending and following-up on improvement plans; writing training courses; contributing information to cross-functional quality improvement teams.

* 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.

* Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

Skills/Qualifications:

Quality Management, GCP, Documentation Skills, Reporting Skills, Analyzing Information, Problem Solving, Process Improvement, Verbal Communication, Informing Others, Attention to Detail, Biohazard Safety