Quality Auditor Sr. job

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.

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 

At Nature, Johns Hopkins' Gundula Bosch describes her graduate program that aims to get doctoral students thinking about the big picture.

Patricia Fara writes about childcare funding, and women in science and science history at NPR.

National Institute of Environmental Health Sciences researchers have visualized the career paths of former postdocs.

A new survey from the Pew Research Center finds that half of women working in STEM have experienced gender discrimination at work.