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Quality Control Auditor II

Date: Jun 10, 2021

Location: Salt Lake City, Utah, US, 84116

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's 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 world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've 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!

Job Description

The purpose of this position is to review QC documentation, to assess compliance/validity with regulatory guidelines in the Quality Control Department, and ensure that all lab work is performed and documented accurately.  The QC Auditor ensures all data generated is done in compliance of GMP.  Ensures compliance with internal procedures (SOPs) and regulatory agencies.  The individual should be familiar with a variety of analytical chemistry concepts, practices, and procedures.  Completes tasks and goals in a timely manner.  Under general supervision is expected to make decisions based on experience and technical knowledge.  Ensures timely completion of all projects and batch release. 
•    Performs peer review of chemist’s work and assembles data packets.
•    Performs LIMS entry and review and maintains database.
•    Generates Test Reports, Certificates of Compliance, and other documents using Excel and Word.
•    Interprets protocols and experimental design for testing plans.
•    Works with LIMS and Empower, and other related software systems.
•    Follows SOPs.
•    Maintains appropriate documentation (records and lab notebooks) as required by SOPs.
•    Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
•    Complies with all current Good Manufacturing Practices (cGMP) current Good Laboratory Practices (cGLP) and safety requirements, laboratory Standard Operating Procedures (SOPs) and Company policies and procedures.
•    Complies with good housekeeping and safety practices.
•    Manages multiple projects and meets deadlines.
•    Performs other related duties as assigned.
•    Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by SOPs.
•    Meets project deadlines and performance standards as assigned.
•    Complies with all Company policies and procedures, including safety rules and regulations     
•    Performs investigations and troubleshooting of analytical test methods and lab instruments.
•    Performs investigation and writes reports on findings, conclusion and identify corrective actions/preventative actions.
•    Performs related duties as assigned.

Qualifications

Bachelor’s Degree in Science or related science field from an accredited college or university and one (2) year related laboratory experience or an equivalent combination of education and experience.

Experience and Skills:

  • Usage of GC and HPLC chromatographic equipment, as well as UV/VIS, dissolution apparatuses, FTIR, Instron operation and other techniques in testing gels, creams, lotions, oral solutions and transdermal system.
  • Business, scientific and personal computer hardware and software applications.
  • Business English usage, spelling, grammar and punctuation.
  • Wet Chemistry and Chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures.
  • Knowledge of or ability to learn FDA, cGLP, cGMP, USP, EP and SOP or other applicable regulatory and safety compliance guidelines.
  • Performing testing accurately and precisely.
  • Responding to routine inquiries from management, employees and regulatory agencies.
  • Communicating clearly and concisely, both orally and in writing.
  • Managing multiple projects, duties and assignments.
  • Establishing and maintaining cooperative working relationships with others.

Function

Quality

Sub Function

Manufacturing Quality Control

Reports To

Senior Manager Quality Control

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.


Nearest Major Market: Salt Lake City