Senior Quality Engineer
Salt Lake City, United States, Utah, 00000
We Are Teva
Our Team, Your Impact
Under minimal supervision, this position is responsible for the facilitation and handling of product related complex customer complaints and manufacturing investigations including, but not limited to, the effective execution and management of quality investigations in response to pre-market and post-market manufacturing issues for both Company and Partner products. Including tracking and trending of complaint data, manufacturing deviations and generation of reports related to investigation activity. The position requires QA review/approval of investigation reports, change controls, Standard Operating Procedures, Process Validation Protocols/Reports, new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents. Leads teams using trend and investigational data to identify potential trends and mitigate through process improvements and failure reduction activities. The individual must perform independently to identify failure modes and related process improvements, facilitating teams and working to implement required changes.
This position receives minimal supervision for most assignments. General instructions are provided for non-standard analyses and projects. Data analysis is complex and requires input from multiple sources and innovative problem-solving. Interfaces to negotiate, collaborate and exchange information with all levels of management. Performs other duties as assigned.
This is a temporary assignment planned to go through 2028
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. Interacts closely with Quality Systems, Operations, Process Technology, Supply Chain, and the Quality Control Laboratory to provide an independent Quality Assurance direction to ensure a thorough and timely review and approval of cGMP documents. Any non-essential functions are assumed to be included in other related duties or assignments.
Primary Activities:
• Responsible for executing and managing investigations for pre-market and post-market manufacturing issues for any products manufactured at the Salt Lake City site.
• Responsible for facilitation and maintenance of communication with applicable associates and managers at the Corporate and Partner level(s) regarding complaint detail through closure.
• Responsible to interact with Production, Engineering, Quality Control and other Production support departments to perform root cause analyses and identify corrective/preventive actions.
• Responsible to identify and investigate post market customer complaint trends.
• Responsible for approving records and acting as backup for management out-of-office.
• Responsible for creating and supporting monthly, quarterly and annual trending reports including compiling analyzing and summarizing data from various databases, reports and other sources.
• Responsible for continuous improvement to increase efficiency; accuracy and compliance.
• Responsible to manage and complete critical Deviation Reports.
• Responsible to review and approve non-complex Deviation Reports.
• Responsible to manage and approve Customer Complaint investigations.
• Responsible to support Manufacturing, Quality Control and Packaging investigations, using root cause analysis tools.
• Responsible to review and approve Standard Operating Procedures.
• Responsible to review Cleaning and Process Validation protocols, reports and deviations.
• Responsible to review and approve SOPs Quality Control Methods, Specifications.
• Responsible to complete special reports and risk assessments.
• Responsible to complete Quality Council Slides and Key Performance Indicator metrics
• Responsible to represent the site and provide support during FDA audits.
• Responsible to represent QA management as a decision maker in cross-functional meetings. Serves as back-up to supervisor, manager and associate director.
• 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.
Secondary Activities:
• Uses data trends to work with Operations and Quality Control to facilitate process improvements and lean concepts.
• Leads cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Leads scheduled and unscheduled audits of operational areas.
• Provides backup to Batch Record Review of production batch records.
• Provides first response and ongoing QA Presence for Quality and Compliance issues in Manufacturing and Packaging operations.
• Contributes to a motivating work environment, where superior performance is defined, supported, rewarded and recognized.
• Participates in external and internal audits.
Your Skills and Experience
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, preferably coursework in scientific or engineering discipline, or equivalent education/ experience.
• Minimum 5-7 years in Quality function, preferably in pharmaceutical, medical device or other regulated industry.
Skills/Knowledge/Abilities:
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP 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.
• Project management or advanced presentation skills desired.
• ASQ CQE/CQA certification is desired.
Problem Solving:
• Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
• Exercises judgment within generally defined practices and policies and selects methods and techniques for obtaining solutions.
• Normally receives little instruction on routine work and general instruction on new assignments.
• May be asked to recommend methods and procedures for problem resolution.
PHYSICAL REQUIREMENTS:
Frequent:
• Sitting for extended periods of time at work station or mobile equipment.
• Using fingers to perform activities such as picking, pinching or typing.
Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Repetitive motions (frequent motions of the wrists, hands and/or fingers).
• Lifting – raising from lower to upper and/or moving objects horizontally up to 25 lbs.
Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
WORKING ENVIRONMENT:
• Exposure to moving mechanical parts or moving equipment.
• Exposure to low to moderate noise levels.
May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).
How We’ll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
We offer a competitive benefits package, including:
- 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.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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