13 days old

Quality Auditor Associate (D1 shift) Mon-Wed and every other Thursday 6:00a-6:30p

Salt Lake City, UT
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Company Info

Teva is a global pharmaceutical leader and the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and weve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth! 

This position is located at our facility in Research Park, near the University of Utah (575 Wakara Way, 84108).

 

Job Description

 

Summary: Under close supervision, conduct AQL inspections on products.  Conducts GMP audits. Review completed intermediate commercial batch records as well as non-commercial experimental records. Resolves GMP Issues on the production floor.  Issues batch records and all supporting documents per the manufacturing master schedule.  Performs sampling activities associated with the commercial manufacturing core, including retain, analytical, and complaint samples. This position is scheduled to work 6:00 am to 6:30 pm Mon-Wed and every other Thursday 6:00 am to 6:30 pm.

 

Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

 

Carries out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.

 

  • Perform issuance of batch records and supporting documents for commercial and non-commercial batches manufactured in the 575 production core.
  • As assigned, perform retain sample product inspections for Annual Product Reviews.
  • Perform sampling and delivery of intermediate and finished products.
  • Assist with retain sample management.
  • Conduct monthly GMP and batch-specific room audits.
  • Conduct AQLs inspections on intermediate and finished products.
  • Control and transfer AQL waste with proper handling.
  • Perform in process record review of commercial manufacturing batch records.
  • Review completed documentation associated with intermediate and finished products; prepare documentation for final disposition.
  • Review completed swab data and perform subsequent room/equipment release.
  • Ensures compliance with all Company policies and procedures, including safety rules and regulations.
  • Performs related duties as assigned.

Qualifications

Required Knowledge and Skills:

Knowledge of:

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration  (FDA), and other regulatory requirements.
  • Principles of auditing.
  • AQL sampling and inspection principles and techniques.
  • Principles of mathematical computations.
  • Business, scientific and personal computer hardware and software applications.
  • Business English usage, spelling, grammar and punctuation.
  • Pharmaceutical principles, practices and their applications.
  • Current  Company  policies,  practices  and  procedures,  including  safety  rules   and regulations.

 

Skill in:

  • Observing and identifying problems, assisting in resolution to support Company goals.
  • Reading, interpreting records, reports, business, personal and scientific computer data, certificates of analysis and conformance and other applicable data sources
  • Responding to inquiries from management, employees and regulatory agencies under direction of management.
  • Communicating clearly and concisely, both orally and in writing.
  • Operating scientific, business and personal computers.
  • Applying Federal, state and local policies, procedures and regulations.
  • Establishing and maintaining cooperative working relationships with others.
  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

 

Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels. Work is performed in the manufacturing production core, warehouse, and office environments.

 

Minimum Qualifications:

  • Requires High School Diploma or equivalent.
  • Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries. 
  • Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment.
  • Associates Degree or higher (or equivalent) achieved or in process preferred.
  • ASQ Certification preferred.

 

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

Senior Quality Assurance Specialist, Spencer Morgan

Tevas Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Posted: 2019-02-05 Expires: 2019-03-07

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Quality Auditor Associate (D1 shift) Mon-Wed and every other Thursday 6:00a-6:30p

Teva Pharmaceuticals
Salt Lake City, UT

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