Scientist

6 days ago

Mumbai Maharashtra, India Novasyte Full time

Job Overview

Perform a variety of testing procedures of moderate to high complexity to obtain data for use in clinical trials research. Perform work in accordance with ICH E6 Guideline for Good Clinical Practice.

Essential Functions
- Perform a variety of testing procedures of moderate to high complexity. Evaluate validity of specimen results as per standard operating procedure (SOP) guidelines. Document all corrective actions taken.
- Provide oversight and guidance to Medical/Histo Laboratory Technicians and/or Assistants. Assist with training of new staff within the assigned group. Train staff Medical Technologists and Medical/Histo Laboratory Technicians and/or Assistants in proper laboratory techniques for existing and new methods.
- Maintain quality control of laboratory testing to ensure accurate and timely lab reporting. Document corrective and preventative actions taken using good documentation practices.
- Assist management in establishing new methodologies. Assist in completion of validation packages.
- Assist management with implementing SOPs for laboratory testing and safety procedures. Implement changes in laboratory notifying all employees of necessary changes. Notify management when updates to department SOP manuals are needed to reflect procedural changes.
- Follow safety procedures as per laboratory SOPs.
- Collaborate with Project Manager with client requests and concerns. Notify management of any delays in testing and any related factors.
- Identify appropriate vendors and orders laboratory supplies as directed by management in order to maintain consistent workflow.
- Participate in continuing education through self-study, attending off-site lectures and preparing programs to share with coworkers.

**Qualifications**:

- Bachelor's Degree or educational equivalent in medical/histo technology Req
- 2 years relevant experience Req Or
- Equivalent combination of education, training and experience Req
- Good knowledge of clinical procedures used in the area of responsibility
- Knowledge of good laboratory practices (GLP) and other regulatory agency standards within area of responsibility
- Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
- Knowledge of laboratory equipment, instrumentation and terminology used in the area of responsibility
- Basic computer skills
- Ability to maintain effective reporting procedures and control workflow
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Good knowledge of clinical procedures used in the area of responsibility
- Knowledge of good laboratory practices (GLP) and other regulatory agency standards within area of responsibility
- Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
- Knowledge of laboratory equipment, instrumentation and terminology used in the area of responsibility
- Basic computer skills
- Ability to maintain effective reporting procedures and control workflow
- Ability to establish and maintain effective working relationships with coworkers, managers and clients

Req

Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other.

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