Senior Investigator - Quality Assurance SLC West

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

This position is responsible for actively investigating deviations and recommending corrective and preventative actions.

How you’ll spend your day

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 evaluating deviation incidents and working with QA to determine if incidents should be escalated to an event investigation.
•    Responsible for conducting comprehensive investigations of complex and/or challenging events as assigned.
•    Responsible for completing all actions necessary in system to document investigations, identify root causes, create and assign appropriate CAPA’s and gain approval and closure of an event.
•    Responsible for hosting meetings to get agreement with area managers and subject matter experts on event root cause and corrective actions.
•    Responsible for maintaining continuous compliance to cGMP documentation of all investigations.
•    Responsible for updating open events tracking system and hosting regular meetings to track the status of all assigned events.
•    Responsible for updating documents (SOPs, MBRs, forms, etc.) as assigned.
•    Responsible for summarizing and presenting investigation trend data as assigned.
•    Responsible for monitoring CAPA’s for completion and effectiveness as assigned.
•    Responsible for completing all training requirements and maintaining 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 (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions. 
•    Responsible for performing additional 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 Engineering or equivalent education/experience with a minimum of 5 years relevant experience in pharmaceutical industry.
•    Prefer degree in Science or Engineering
•    Preferred experience within engineering, production, quality, validation or other relevant functional area.
•    Experience in Solid Dose manufacturing environment preferred.
•    Requires experience with the handling of deviations, investigations and CAPA’s.
•    Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
•    Experience with Manufacturing/Quality systems such as Trackwise, Learning Management Systems, ERP Systems, and statistical software preferred.

Skills/Knowledge/Abilities:
•    Detail oriented with ability to analyze information and create corresponding performance metrics.
•    Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
•    Ability to demonstrate sound judgment and decision making.
•    Ability to build and maintain collaborative relationships between teams, departments and business units.
•    Motivate, influence and lead others with and/or without direct supervisory authority.
•    Communicate effectively with excellent written and oral communication skills.
•    Interact positively and collaborate with co-workers, management and external partners.
•    Manage conflict and negotiate resolution.
•    Self-directed with ability to organize and prioritize work. 
•    Project management and advanced presentation skills preferred.
 

Problem Solving:
•    Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of