Quality Engineer II

Teva Pharmaceuticals • Salt Lake City, UT

1d

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.Our Team, Your ImpactPOSITION SUMMARY: Under minimal supervision, this role is responsible for managing complex product-related customer complaints and manufacturing investigations for both Company and Partner products. This includes execution of quality investigations related to pre-market and post-market manufacturing issues, as well as tracking, trending, and reporting of complaint and deviation data. Provides Quality Assurance support across Manufacturing, Packaging, Supply Chain, and Quality Control. Responsible for the review and approval of investigation reports, change controls, SOPs, validation protocols/reports, maintenance work orders, and other cGMP documentation. Leads cross-functional teams to identify trends, determine root cause, and drive process improvements and failure reduction activities. This role requires strong independent problem-solving, data analysis, and the ability to collaborate with all levels of the organization.

Requirements

• Bachelor’s degree, preferably coursework in scientific or engineering discipline, or equivalent education/ experience.
• A minimum of 3 years in Quality function, preferably in pharmaceutical, medical device or other regulated industry.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise Harmony.
• Must be experienced at creating performance metrics, having performed the corresponding analysis and reports.
• Detail oriented, team player with strong interpersonal skills.
• Demonstrated working knowledge of cGMP and applicable regulatory requirements.

Nice To Haves

• Project management or advanced presentation skills desired.
• ASQ CQE/CQA certification is desired.

Responsibilities

• Lead and manage investigations for pre-market and post-market manufacturing issues
• Facilitate communication with internal teams and external partners throughout investigation lifecycle
• Perform root cause analysis and identify corrective and preventive actions (CAPAs)
• Analyze and trend customer complaints and manufacturing deviations
• Generate monthly, quarterly, and annual reports by compiling and analyzing data from multiple sources
• Manage complex deviation reports and review/approve non-complex deviations
• Review and approve customer complaint investigations
• Support Manufacturing, Packaging, and Quality Control investigations
• Review and approve change controls, SOPs, validation protocols/reports, and maintenance documentation
• Act as backup for management as needed
• Ensure compliance with company policies, cGMPs, SOPs, and safety standards
• Perform additional 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees