Objective:

This position requires the incumbent to give support to manufacturing department for testing of Raw material, Packaging material, Intermediate/In-process samples, Stability samples, Finished API’s.

 

Essential Job Duties:

·  Performs testing utilizing multiple QC equipment

·  Conducts sampling and testing for raw materials to Finished APIs

·  Performs wet chemical analysis for raw material to Finished APIs

·  Performs sampling and monitors process water system and temperature graphs for freeze, freezers and stability chambers

·  Responsible for testing and releasing for all packaging materials

·  Provides packaging working standards, impurity standards and samples for customers as requested

·  Performs additional testing and documentation for deficiencies and other validation and regulatory requirements

·  Maintains lab, instruments, log books and notebooks at all time

·  Maintains lab instruments and performs calibrations/preventive maintenance to ensure proper working order and troubleshoot when necessary

·  Prepares solutions, compounds, reagents for conducting testing

·  All other duties as assigned for Quality Control requirements

 

Experience & Education: Minimum Bachelor Degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or the equivalent required.

 

Knowledge: Must possess knowledge of generic pharma, variety of pharma manufacturing technologies, SOPs and cGMPs

 

Skills & Abilities:

• Ability to work independently with little to no supervision
• Exceptional oral and written communication capabilities
• Advanced computer knowledge in MS Office programs
• Excellent organizational abilities and superior attention to detail
• Must have high level of interpersonal skills
• Ability to maintain high level of confidentiality at all times
• Possesses strong analytical and problem solving skills
• May be required to sit, stand, walk regularly and lift, push, pull up to 50 pounds continuously

 

Working Conditions: Position will be mainly Quality Control lab bench work based with a clerical component in addition to physical requirements.  Incumbent will be working in a laboratory and manufacturing facility and will be exposed to these environments. Minimal travel required