Sr Quality Engineer

Teva Pharmaceutical Industries • Salt Lake City, UT

44d

About The Position

This position is responsible for providing Quality Assurance support to Manufacturing, Supply Chain and Quality Control Laboratories by providing QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents. This position leads cross-functional teams to track and trend investigational data, and create value through process improvements and failure reduction activities. The Senior Quality Engineer provides representation for quality management.

Requirements

• Requires a Bachelor's Degree or equivalent with a minimum of seven 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.
• 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.

Nice To Haves

• Prefer degree in Science or Engineering.
• Preferred experience in a solid dose manufacturing environment.
• Experience with managing partner relationships preferred.
• 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.
• Project management and advanced presentation skills preferred.

Responsibilities

• Responsible for providing a thorough and timely review/approval or author/execution 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 leading 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 deviation from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of critical, complex and/or challenging events as assigned.
• Responsible for serving as QA lead on research and development products and related document reviews/approvals - including change control items, protocols, batch records and deviations as applicable and product disposition.
• Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
• Responsible for compiling and maintaining metrics and tracking logs for site's quality KPI's or other functions.
• Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM.
• Responsible for serving as QA backup for final review/release of production batch records, managing the site change control system and for validation/qualification protocols and related activities.
• 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.

What This Job Offers

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