Quality Analyst II

Teva Pharmaceutical Industries•Salt Lake City, UT

40d

About The Position

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 POSITION SUMMARY This role provides Quality Assurance support to Manufacturing, Supply Chain, and Quality Control Laboratories. Responsibilities include reviewing and approving QA methods, procedures, protocols, investigation documents, and change control documents. The position uses trend and investigational data to improve processes and reduce failures, while representing the quality department on cross-functional teams.

Requirements

Requires a Bachelor's Degree or equivalent with a minimum of three years relevant progressive QA experience in the pharmaceutical or a related industry.
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.
Requires experience with the handling of deviations, investigations and CAPA's.
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.
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.

Nice To Haves

Prefer degree in Science or Engineering.
Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
Experience with laboratory related investigations/inquiries preferred.
ASQ/CQE/CQA Certification preferred.

Responsibilities

Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and reports, and facility controls, instruments and procedures.
Responsible for working with operating departments to facilitate process improvements and lean concepts.
Responsible for participating in cross functional improvement and process monitoring teams to mitigate unfavorable trends.
Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
Responsible for evaluating reports of deviations from defined processes 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 investigating critical events, supporting other quality team members in the analysis and documentation.
Responsible for compiling and maintaining metrics and tracking logs for site's quality KPI's or other functions.
Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM
Responsible for serving as QA backup as final review/release of production batch records.
Responsible for completing 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.

Benefits

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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