Teva Senior Quality Auditor - SLC East Friday 

United States, Utah, Salt Lake City 

190983180

Under minimum supervision, ensures compliance to cGMP regulations in manufacturing area including all documentation complying with the Company's Standard Operating Procedures (SOP's), governmental regulations and other requirements where applicable. Facilitates communication between departments to ensure a smooth flow of materials and release. Perform batch record review of intermediate and finished materials. Perform release of intermediate materials.

Requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills -- Builds knowledge of the organization, processes and customers -- Solves a range of straightforward problems -- Analyzes possible solutions using standard procedures -- Receives low to moderate level of guidance and direction

· Carries out lead responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.

· Assists in the training of new auditors in job duties according to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Company training procedures.

· Perform review of intermediate and finished material batch records.

· Interface with manufacturing, warehouse, and QC materials management to ensure timely and accurate shipment of materials and products.

· Audit data from Quality Control, vendor's certificate of analysis, and other relative documentation of products and materials.

· Prepare, revise and verify SOP, Sampling Plans, MPRs, Swab Data, and BMS system data.

· Maintain Quality Assurance documentation files, databases and logs.

· Assist in preparing budgets and reviews.

· Conduct final audit of Laboratory Service Reports for in-process and finished product reports, assuring compliance with cGMPs, current Good Laboratory Procedures (cGLPs), test methods and SOPs and prepare documentation for release.

· Conduct audits of other documents as directed by the Supervisor and prepare these documents for release, assuring compliance with cGMPs and SOPs.

· Interface with other department's personnel to complete job duties.

· Participates in and provides training programs for the development of successful working understanding of materials presented and become more proficient in assigned duties and tasks.

· Provides support, direction, and coaching to team members in the areas of training, problem resolution, planning, and work assignment delegation.

· Ensures project deadlines and performance standards are established and met.

· Ensures compliance with all company policies and procedures, including safety rules and regulations.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

· Bachelor's Degree in Science or related field from an accredited college or university, and/or 3-5 years pharmaceutical quality assurance auditing experience. An equivalent combination of education and experience may be substituted.

· Observing and identifying problems, assisting in resolution to support Company goals.

· Reading, interpreting records, reports, business, personal and scientific computer data, certificates of analysis and conformance and other applicable data sources

· Responding to inquiries from management, employees and regulatory agencies under direction of management.

· Communicating clearly and concisely, both orally and in writing.

· Operating scientific, business and personal computers.

· Applying Federal, state and local policies, procedures and regulations.

· Establishing and maintaining cooperative working relationships with others.

· Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

· Advanced principles of auditing.

· AQL sampling and inspection principles and techniques.

· Principles of mathematical and statistical computation and analysis.

· Business, scientific and personal computer hardware and software applications.

· Pharmaceutical principles, practices and their applications.

· Leadership and training methods and techniques.

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