Quality Analyst

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Salt Lake City, United States, Utah, 84116

Job

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.

This position is primarily responsible for the review of batch record files and final product release for shipment to end customer and to participate in investigations and trending of quality issues as appropriate. Additionally, this position will support QA Production Operations for all manufactured batches and issue/review/release raw materials, labeling materials and packaging materials as needed and for providing general guidance and instruction to correct identified deficiencies during documentation reviews and other oversight as needed to ensure compliance with company procedures and domestic and international regulatory requirements.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for conducting review and release activities associated with manufactured product release with some oversight, but minimal and directed at anomalous issues or observations.
• Responsible for performing activities to support Production Operations which includes floor support, audit/walkthrough support, AQL assessment, investigation assessment, and training.
• Responsible for compiling and maintaining metrics and tracking logs at the request of management and is responsible for successfully hitting metrics delivery schedules.
• Responsible for reviewing and approving edits to Master Batch Records submitted for revision and for ensuring accuracy and GMP compliance in documents that are being reviewed.
• Responsible for supporting investigations and process improvement initiatives in the Quality and Production Areas as well as supporting ongoing quality and compliance initiatives at the site including support of Lean Management initiatives (TLMS) (i.e. reducing events or documentation related to human errors).
• Responsible for revising or reviewing Standard Operating Procedures (SOPs), forms and/or Work Instructions with changes of low complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

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

Education/Certification/

Experience:

• Requires a Bachelor’s degree or equivalent education/experience with a minimum of three years relevant experience in a manufacturing environment within pharmaceutical, medical device, nutraceutical, or food processing industries preferred.
• Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• ASQ Certification preferred but not required.

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working…