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Scientist II , Verification Programs @ United States

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 Scientist II , Verification Programs

Job Description

Summary of the Position:

This is a key hands-on, non-supervisory position. In this role, the Scientist performs the required analytical tests of Dietary supplements samples using appropriate methods. The Scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. The Scientist has mastered many common techniques in the laboratory and is able to contribute his/her own observations and input to difficult projects. The incumbent will provide technical assistance to the Verification Program by performing analytical tests and preparing summary reports.

Roles and Responsibilities:

  • Executes the Verification projects by performing individual analytical tests allotted by the Group Leader.

  • Completes the projects as per the project timelines and priorities.

  • Demonstrates solid scientific approach to analysis in the laboratory.

  • Routinely applies personal experience, academic training, and technical insights including emerging sciences to solve complex technical problems within the laboratory;

  • Compiles project reports and responds QA observations.

  • Executes all testing and analysis of data with excellence and essentially no errors;

  • Demonstrates a strong desire to continue learning and grow personal capability;

  • Pursues, recommends, and implements new approaches or processes to improve laboratory operations;

  • Positively influences project direction by ensuring own work is congruent with overall direction of laboratory projects;

  • Assists with other testing programs and housekeeping duties in the laboratory as needed.

  • Ensures the implementation of GLP, safety systems in labs.

  • Ensures the calibration of the equipment as per the schedule.

  • Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.

  • Ensures and follows USP mission, policies and procedures.

  • Maintains good relationship with QA, HR, Purchase, accounting, IT and other dept.

  • Preparation and planning for ISO-9001 ISO- 17025 certification/recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.

  • Supports collaborative testing, GPH, RSL and other departmental teams in terms of project testing, review, execution and approval whenever needed.

Required Skills

  • Ability to lead projects to completion with a high degree of scientific expertise.
  • Proficient with pharmaceutical testing requirements and test protocols involving compendial methods (USP, BP, EP, etc.).
  • Expert in ICP-OES, HPLC, GC,ICP-MS,LC-MS, Dissolution analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, etc), strong communication and presentation skills, both verbal and written, experience working in the pharmaceutical industry strongly preferred.
  • Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred.
  • Proficiency with electronic documentation systems strongly preferred.
  • Takes personal responsibility to ensure work is delivered on time and is the highest possible quality.
  • Skills to anticipate, troubleshoot, and solve technical problems.

Required Experience

  • Master s degree in pharmacy or Analytical chemistry.

  • Minimum 3 to 5 years of relevant laboratory experience.

Job Classification

Industry: Pharma, Biotech, Clinical Research
Functional Area: IT Software - Application Programming, Maintenance,
Role Category: Programming & Design
Role: Programming & Design
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization
Post Graduation: Any Postgraduate in Any Specialization
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization

Contact Details:

Company: United States
Location(s): Hyderabad

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Keyskills:   Housekeeping QA Analytical chemistry Pharmacy Instrumentation GLP ISO 17025 Scientist II Technical support HPLC

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United States

United States Pharmacopeia-India (P) Limited