Quality Auditor Sr. job

Organization
Actavis, Inc.
Job Location
Salt Lake City, UT
Job Description

Under general supervision, ensures compliance to cGMP regulations in a pharmaceutical manufacturing area including all documentation. Essential functions include: - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. 
- Ensures compliance with all Company policies and procedures, including safety rules and regulations. 
- Facilitates communication between departments to ensure efficient flow of QA activities related to the production schedule, including but not limited to document issuance, production room audits, AQL sampling/testing, collection/delivery of samples, ERP activities, expiration date monitoring, intermediate product review/releases and finished product review. 
- Interfaces with manufacturing, warehouse, QC, and materials management to ensure timely and accurate shipment of products. 
- Reviews data from Quality Control, including Swab Data. 
- Prepares, revises, and verifies SOPs and forms. 
- Monitors environment as needed. 
- Maintains Quality Assurance documentation files, databases, and logs. 
- Assists in preparing capacity planning data. 
- Monitors training for compliance. 
- Prepares and conducts GMP training to Manufacturing and Quality Assurance staff as needed. 
- Manages Retain samples. 
- Right the First Time monitoring. 
- Maintains effective Writing skills in conducting change control, investigations, and CAPA related activities. 
- Performs related duties as assigned.

Requirements: 
Three (3) years pharmaceutical quality assurance auditing experience or an equivalent combination of education and experience.Knowledge of: 
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), DEA (Drug Enforcement Agency), European Medicines Agency (EMA) and other regulatory requirements. 
- Principles of auditing and performance evaluations. 
- AQL sampling and inspection principles and techniques. 
- Principles of mathematical and statistical computation and analysis. 
- Business, scientific and personal computer hardware and software applications. 
- Business English usage, spelling, grammar and punctuation. 
- Pharmaceutical principles, practices and their applications. 
- Current Company policies, practices and procedures, including safety rules and regulations. 

Note: Work Schedule; Fri-Sun, every other Th, 6:00 p.m. - 6:30 a.m. 

*Position does not include a relocation benefit. 

Bachelor’s Degree in Science or related field from an accredited college or university.*LI-WK1 

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