Quality Auditor

Stefanini Group • Salt Lake City, UT

7h • Onsite

About The Position

Stefanini Group is hiring! Stefanini is looking for Quality Auditor in Salt Lake City, UT For quick Apply, please reach out to Sangeeta Dasadhikary- call: 2485826547 / email: [email protected] Work Hours: M-F (40 hours) Work Location: Salt Lake City, UT Shift Time: 3rd Shift (10:00 PM – 6:30 AM) Responsibility: Perform sampling and delivery of intermediate and finished products. Assist with retain sample management. Conduct monthly GMP and batch-specific room audits. Perform in process record review of commercial manufacturing batch records. Review completed swab data and perform subsequent room/equipment release. Ensures compliance with all Company policies and procedures, including safety rules and regulations. Performs related duties as assigned. Materials and samples: Handling of pharmaceutical drug products, including topical patches, ointments, gels, and creams, as well as an oral liquid dosage form (oral suspension) as well as some combination products such nasal sprays, pump products, and vaginal applicators. Our drug products include non-controlled substances as well as some DEA controlled substances (schedule III and IV), as well as hormones. Details: Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries. Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment. Associate's degree or higher (or equivalent) achieved or in process preferred. Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems. Self-directed with ability to organize and prioritize work. Ability to communicate effectively with excellent written and oral communication skills. Ability to interact positively and collaborate with co-workers and management. Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers. About Stefanini Group The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company. #LI-SD2 #LI-Onsite

Requirements

• Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries.
• Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems.
• Self-directed with ability to organize and prioritize work.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers and management.

Nice To Haves

• Associate's degree or higher (or equivalent) achieved or in process preferred.

Responsibilities

• Perform sampling and delivery of intermediate and finished products.
• Assist with retain sample management.
• Conduct monthly GMP and batch-specific room audits.
• Perform in process record review of commercial manufacturing batch records.
• Review completed swab data and perform subsequent room/equipment release.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees