Job Information
Teva Pharmaceuticals Lead Documentation Specialist - SLC East in Salt Lake City, Utah
Lead Documentation Specialist - SLC East
Date: Apr 22, 2024
Location:
Salt Lake City, United States, Utah, 84108
Company: Teva Pharmaceuticals
Job Id: 53778
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
This position provides Quality Documentation support for the cross-functional departments. This position has the responsibility to support 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 coordination and publishing of documents are completed in a timely manner with a high degree of accuracy.
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. Any non-essential functions are assumed to be included in other related duties or assignments.
Responsible for independently performing day-to-day tasks that occur in a Document Control Function (typing, filing, research, etc.).
Responsible for assisting in coordination of the review and revision of controlled documents (master batch records, procedures, specifications, test methods and forms) to ensure consistency in format and presentation of content for all documents.
Responsible for helping to ensure adequate and compliant document change control practices.
Responsible for assisting with the organization and maintenance of files for submitted documents, all master documents and document history as needed.
Responsible for issuing documents, and GxP records to appropriate personnel, in a timely manner.
Responsible for effectively interacting with other functional groups (e.g., Production, external regulatory affairs, etc.)
Responsible for assisting in the coordination of activities related to the implementation and maintenance of an EDMS (electronic document management system).
Responsible for assisting in writing and/or revising departmental Standard Operating Procedures as needed.
Responsible for effectively addressing CAPA and deviation resolutions as needed.
Responsible for generating reports from EDMS and other software applications.
Responsible for supporting regulatory agency audits with ability to field and respond to audit requests (backroom lead).
Responsible for representing Document Control on project/product teams as assigned.
Responsible for training and providing guidance to lower level employees as needed.
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.
Your experience and qualifications
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/GED or equivalent, with 4 or more year’s relevant, progressive experience in pharmaceutical or device manufacturing environment.
Would prefer an associate degree with a minimum of 3 years’ experience, progressive experience in pharmaceutical or device manufacturing environment.
Working knowledge of GMP regulations required.
Skills/Knowledge/Abilities:
Computer proficiency with emergent working knowledge of MS Office products, Learning Management Systems (LMS), EDMS.
Understanding of ERP systems, as well as Quality systems such as Trackwise preferred.
Ability to handle and move between multiple tasks.
Ability to train other personnel on new assignments and larger groups on new systems and/or processes.
Interact positively and collaborate with co-workers, management and external partners.
Self-directed with ability to organize and prioritize work.
Communicate effectively with excellent written and oral communication skills.
Problem Solving:
Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.
Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.
Selects methods, techniques, and evaluation criteria for obtaining results.
Acts independently and proactively to recommend methods and procedures for problem resolution.
Enjoy a more rewarding choice
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.
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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
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.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
This position is not eligible for sponsorship. To be considered for this opportunity, you must apply on our career page.
EOE including disability/veteran