Senior Quality Auditor - SLC East (Mon- Fri 2pm - 10:30pm)

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

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. 

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. This role requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills. Build knowledge of the organization, processes, and customers. Solve a range of straightforward problems. Analyzes possible solutions using standard procedures. Receives low to moderate level of guidance and direction. Any non-essential functions are assumed to be included in other related duties or assignments.   

• 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 related 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. 

Your experience and qualifications

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

Education/Certification/Experience: 

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

Skills: 

• 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 coopera