Teva Pharmaceuticals USA, Inc.

Manufacturing Science & Technology(MS&T) Specialist I

US-UT-Salt Lake City
Requisition #
17-19518
# Positions
1
Experience (Years)
1
Category
Operations - Operations Management

Overview

Under general supervision, determines the critical aspects of manufacturing equipment with regard to product and process, and writes protocols and other records related test results. Prepares final reports that identify the results of protocol testing and the conditions of release. Assists in conducting efficiency studies and in the identification of process improvement opportunities. Participates in project coordination activities.

 

Responsibilities

 

Responsibilities:

  • Carries out responsibilities in accordance with the organization’s policies, procedures,

          and state, federal and local laws.

  • Provides assistance in troubleshooting to manufacturing and packaging areas.
  • Interfaces with Quality Assurance and Research and Development (R&D) on process

          requirements for new and current products.

  • Assists with on-site transfer projects and product scale-up activities.
  • Recommends improvements in manufacturing and control systems.
  • Assures that protocols are approved through proper channels; writes and revises

          validation protocols.

  • Executes validation protocols per related SOPs and assures that acceptance criterion

          related to validation protocols are met.

  • Assures that all test data is gathered and recorded in accordance with cGMP

          requirements.

  • Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation

           reports as required upon failures to meet protocol acceptance criteria.

  • Writes reports and assures that they are approved through proper channels.
  • Provides support in investigations and other troubleshooting activities.
  • Prepares batch record documentation.
  • Develops and communicates project timelines and status.
  • Complies with all GMP and safety requirements, SOP’s and Company policies and

           procedures.

 

Qualifications

Requirements:

 

Bachelor’s degree in Science or related field from an accredited college or university and one (1) to two (2) years’ experience; or an equivalent combination of education and experience. Graduate degree preferred.

 

Preferred Qualifications:

  • One (1) to two (2) years process technician or laboratory experience in a manufacturing environment.
  • Knowledge of or ability to learn pharmaceutical manufacturing principles, practices and applications.
  • Ability to work and contribute in a positive, collaborative and dedicated team environment.
  • Knowledge of or ability to learn pharmaceutical product equipment qualification/calibration concepts.
  • Knowledge of or ability to learn pharmaceutical raw material and finished product tests, results and interpretation.
  • Experience in writing clear and concise technical documents (Batch Record, Change Control, Protocols, Summary and Evaluation reports).
  • Project management experience; ability to simultaneously manage multiple projects, duties, and assignments.
  • Ability to read, write and speak English in order to complete and generate training, reports and or revise or update documentation files, databases, and logs accordingly.
  • Ability to lift up to 25 lbs., climb stairs & ladders, work in moderate to loud noise environment and wear GMP appropriate attire as required.
  • Intermediate skills in Microsoft Office Suites (Word, Excel, Access, PowerPoint, MS Project)
  • Intermediate statistical analysis, computations, and test methodology experience; Knowledge of JUMP or MINI TAB helpful.

Knowledge of or ability to learn current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.

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