Quality Investigation Specialist
On-Board
- Somerset, NJ
- $30.00-32.00 per hour
- Permanent
- Full-time
For immediate consideration please send your resume to
Subject Line: Position Title and State you are LocatedAbout Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.Position Details:
Position Type: Full-Time/Contract
Job Location: Somerset NJ
Benefits: 401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Pay Rate: $30-32 per hourResponsibilities
· Perform routine tests of raw materials, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
· Evaluates test results and decides acceptability of the samples based on the test results.
· Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
· Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
· Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.
· Design and develop test methods, perform experimental tests and evaluate performances.
· Write test methods, method validation protocols and reports.
· Establish test specifications and communicate with internal and external customers.
· Analyze and interpret results in written and oral format.
· Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment
Qualification
Bachelor’s degree in Chemistry or related scientific field and 2+ years related experience in pharmaceutical analysis OR Master’s degree in Chemistry or related scientific field and 1+ year related experience in pharmaceutical analysis.
To perform this job successfully, an individual should have:
- Ability to deal with problems involving several concrete variables in standardized situations.
- Ability to carry out necessary computations and to draw and interpret graphs.
- Working knowledge of instrumentation software used in the laboratories.
- Aid in the writing of laboratory practices and procedures.
- Helps assist in the generation of laboratory practices and modifications of standard operating procedures.
- Assist in the validation of Quality Control methods.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Knowledge of Excel and MS Office Suite Word Processing software.
- Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.
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