QA Auditor - SLC East (Mon-Fri 8am - 5pm)

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 close supervision, conduct AQL inspections on products.  Conducts GMP audits. Review completed intermediate commercial batch records as well as non-commercial experimental records. Resolves GMP Issues on the production floor.  Issues batch records and all supporting documents per the manufacturing master schedule.  Performs sampling activities associated with the commercial manufacturing core, including retain, analytical, and complaint samples.

How you’ll spend your day

This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

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

•    Perform issuance of batch records and supporting documents for commercial and non-commercial batches manufactured in the 575 production core.
•    As assigned, perform retain sample product inspections for Annual Product Reviews.
•    Perform sampling and delivery of intermediate and finished products.
•    Assist with retain sample management.
•    Conduct monthly GMP and batch-specific room audits.
•    Conduct AQLs inspections on intermediate and finished products.
•    Control and transfer AQL waste with proper handling.
•    Perform in process record review of commercial manufacturing batch records.
•    Review completed documentation associated with intermediate and finished products; prepare documentation for final disposition.
•    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.

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 one (1) year pharmaceutical, medical device, nutraceutical, or food processing quality assurance 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 cooperative working relationships with others.
•    Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

Knowledge/Abilities:
•    Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
•    Principles of auditing.
•    AQL sampling and inspection principles and techniques.
•    Principles of mathematical computations.
•    Business, scientific and personal computer hardware and software applications.
•    Business English usage, spelling, grammar and punctuation.
•    Pharmaceutical principles, practices and their applications.

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(