Scientist - Carmel, NY | Biospace
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Scientist

HumanEdge

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Location:
Carmel, NY
Posted Date:
9/22/2017
Position Type:
Full time
Job Code:
282356
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Scientist,

Job Description

Our client is currently in need of a contract Scientist to support the QC laboratory testing functions.

 
  • Perform physical and chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process and finished products, using various wet chemical, physical and instrumental techniques.
  • Plan and execute testing to meet established deadlines.
  • Ensure that the laboratory testing techniques and documentation comply with GMPs, SOPs
  • Record data and results
  • Ensure that all information is entered into databases for trending and capacity modeling purposes.
  • Review and approve data and results
  • Assist in performing investigations of out-of-specification and out-of-trend data and communicate to the manager and affected departments.
  • Monitor metrics and communicate information and recommendations to QC Manager.
  • Initiate, author and revise test procedures, SOPs, technical reports, and other documents.
  • Maintain and improve laboratory efficiency by implementing improvements, new techniques, training, new processes and/or improvements to work flow.

Requirements

Minimum of a BS Degree in Chemistry or related discipline

  • At least 5 years of pharmaceutical QC Laboratory testing experience in a cGMP-regulated laboratory environment.
  • Knowledge of GMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations.
  • Excellent communication skills.
  • Expertise in Microsoft Word and Excel.
  • Strong troubleshooting and investigation skills.
  • Thorough knowledge of laboratory test procedures and instrumentation, especially HPLC; USP/NF methodology; relevant regulatory requirements.
  • Ability to read and interpret test procedures, manuals, technical documents or instructions in mathematical or diagram form, SOPs and governmental regulations.
  • Ability to summarize and explain such documents to the QC Laboratory staff as well as to non-scientists.