Athens, GA - Project Coordinator

Job Description:

• To provide general support and coordination of activities for the Technical Services group (which includes the active pharmaceutical ingredient and chemical impurity Reference Standards Program), as well as to the overall Scientific Affairs department
• This support includes reference standards daily operations, logistics and material movement, documentation support, purchasing support, DEA coordinator duties, SAP support, and other duties as required by the Scientific Affairs department
• In addition, this role will interact with external and internal customers with regard to reference standards supply and qualification, material movement, and customer inquiries
• Day to day oversight of the Reference Standards Program:
• Technical resource for active pharmaceutical ingredient and chemical impurity reference standards
• Create documents such as batch records, worksheets, reports and CoAs
• Maintain inventory control via SAP
• Schedule and coordinate scientific experiments for the replenishment (chemical synthesis & analytical qualification) of reference standards and materials in consultation with supervisor
• Package and ship materials (including high potency compounds) to internal/external customers
• Track reference standards budget, provide financial analysis, and competitor price evaluation
• Communicate with DEA regarding quota and material movements to maintain compliance
• Communicate with Customer Service to meet customer requirements
• Implement continuous improvement processes to the Reference Standards Program
• Other duties as needed to support the Reference Standards Program
• Summarizes and conducts preliminary data interpretation, including the use of statistical packages and standard databases
• Records all information obtained in the laboratory according to established procedures and specifications Maintain and provide notebooks, records and documentation that are current, legible, readily understood, complete, accurate and verifiable as required or requested
• Ensures that records and raw data are properly retained
• Assists in preparation of technical reports and other documents that record data or results
• Issue, update and review Scientific Affairs documents as needed
• Serve as DEA coordinator for the Scientific Affairs department; participate in DEA audits

REQUIREMENTS:

• Minimum requirements include a Bachelor’s degree (B.S.) in Chemistry or related area of study and 1-3 years of work experience using basic laboratory skills or chemical analysis
• Knowledge of chemical manufacturing and GMP regulations highly preferred
• An equivalent combination of education, training, and experience may be used to meet the minimum qualifications
• Knowledge of cGMP regulations is required
• Use computer software and customize programs to meet business needs, including word processing and mathematical applications
• MS Excel knowledge required
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production
• Must be able to work with people, influencing their output and work behavior
• Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production
• Ability to perform under stress in cases of emergency, critical or hazardous situations
• Must have the ability to make independent decisions within general guidelines and to work under minimum supervision
• Must be highly organized and have the ability to prioritize multiple tasks to meet business needs
• Role will work a traditional M-F work schedule

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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