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Quality Documentation Specialist

Date: Jun 21, 2019

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!

 

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. This position is located at our facility in the International Center, near the Salt Lake City International Airport (4745 Wiley Post Way, 84116). For more on Teva, check us out at www.tevapharm.com or www.tevausa.com.

Job Description

 

POSITION SUMMARY

 

This position has the responsibility to assist and support all Document control functions in a pharmaceutical environment.  This person will assist in ensuring compliance with regulatory requirements and will interact with all areas within the company to ensure that change control policies are followed with a high level of accuracy. 

 

ESSENTIAL AREAS OF RESPONSIBILITY

 

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

 

  • Responsible for ensuring document control and regulatory compliance with emphasis on document management in pharmaceutical production.
  • Assist in coordination of the review and revision of controlled documents (master batch records, procedures, specifications, test methods and forms).  Ensure consistency in format and presentation of content for all documents.
  • Help to ensure adequate and compliant document change control practices.
  • Assist in organizing and maintaining files for all master documents and document history.
  • Assist in compiling regulatory filing documents.
  • Issue documents, binders and batch records to appropriate personnel, in a timely manner.
  • Effectively interact with other functional groups (e.g., Production, VCTS, external regulatory affairs, etc.)

Qualifications

 

POSITION REQUIREMENTS

 

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

 

Education/Certification/Experience:

  • Requires a high school diploma and two to four years experience in a Document Control, Clerical or Secretarial position.
  • Pharmaceutical Manufacturing or Medical Device background strongly preferred.

 

Skills/Knowledge/Abilities:

  • Working knowledge of GMO regulations required.
  • Computer proficiency with MS Office and internet tools.
  • Ability to handle and move between multiple tasks. 
     
     
    Problem Solving (to be completed from pre-defined language in Position Description Worksheet):
  • 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 no instruction on routine work and receives general instructions on new assignments.
  • May provide guidance to other nonexempt or temporary personnel on new assignments.

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

In process of validation

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.


Nearest Major Market: Salt Lake City