Teva Pharmaceuticals USA, Inc.

Chemist II

US-NJ-Elizabeth
Requisition #
17-20159
# Positions
1
Category
Research & Development - Pharmaceutical

Responsibilities

Summary: Performs testing of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records.

 

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 organization’s policies, procedures, and state, federal and local laws.
  • Complies with all current Good Laboratory Practices (cGLP), current Good Manufacturing Practices (cGMP) and safety requirements and laboratory Standard Operating Practices (SOPs).
  • Performs difficult analytical techniques such as complex procedures involving multiple extractions, titration, timed reactions and normal phase HPLC with a minimum of assistance and direction.
  • Assists in providing training to new staff and ongoing training to current staff; assists in providing work direction and review, and schedules work in absence of supervisor.
  • Operates, maintains and troubleshoots all laboratory equipment, solves analytical problems that involve troubleshooting equipment and laboratory method, and reports method issues to Supervisor.
  • Operates general analytical instruments for all routine testing (i.e., HPLC, GC, UV, automatic titrator, and IR).
  • Performs wet chemistry tests (i.e., LOD, pH, titration, etc.).
  • Labels, transcribes and records data on approved report sheets, maintains appropriate documentation (records and lab notebooks) of tests and assays, and performs all necessary calculations associated with test analysis as required by SOP’s.
  • Prepares written reports including investigations, validation studies, and recommendations to revised laboratory test methods, SOPs, GTP’s and work requests.
  • Trains all levels of new and current employees and provides direction in daily tasks.
  • Reviews and audits analytical data from other laboratory personnel.
  • Complies with good housekeeping and safety practices; ensures the collection and proper disposal of hazardous waste from laboratory instruments.
  • Participates in troubleshooting of analytical test methods and laboratory instruments.
  • May provide direction on assignments.
  • Takes part in the training program as a qualified trainer, as requested.
  • Performs related duties as assigned.
  • Reviews test methods.

LI-CA1*

 

Qualifications

Minimum Qualifications: Minimum Qualifications: Bachelors degree in Chemistry or related science from an accredited college or university; and a minimum of zero (0) – one (1) years of related laboratory work experience in a pharmaceutical environment; or an equivalent combination of training and experience.

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

  • Quality control systems.

  • Basic math skills, including basic statistics.

  • Basic Chemistry or related sciences.

  • FDA compliance standards, regulations and guidelines.

  • Sample preparation techniques.

  • Spectroscopic techniques.

  • Chromatographic system.

  • Computer applications and programs.

  • Compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.

 

Skill in:

  • Reading, understanding and complying with Company policies and procedures, including safety rules and regulations.
  • Operating a personal computer.
  • Providing leadership and training to all levels of the Chemist position.
  • Troubleshooting and problem solving laboratory equipment and methods.
  • Accurately and precisely performing testing.
  • Communicating clearly and concisely, in English, both orally and in writing.
  • Establishing and maintaining cooperative working relationships with those contacted in the course of work.
  • Chemist License preferred in Puerto Rico.

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