Associate Scientist, Quality Control

DUTIES AND RESPONSIBILITIES – PRIMARY ROLE:

• Perform physical and chemical testing of raw material, packaging material, in-process, release, and stability samples.
• Record experimental data, analyze results, and maintain accurate and up-to-date notebooks.
• Assist in maintaining the laboratory in compliance with SOPs, CGMPs, FDA, OSHA and other guidelines.
• Assist in filing laboratory documents.
• Use and maintain instruments, such as HPLC, GC, Dissolution, UV-VIS, IR, Titrator, etc.
• Troubleshoot and perform minor maintenance and repair of lab instrumentation.
• Support investigation and troubleshooting of analytical issues.
• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, DEA, EPA and OSHA.
• Support ANDA/NDA projects from development to approval with guidance.
• Support method development and method validation work.
• Perform calibration and maintenance of various analytical equipment.
• Assist in writing technical documents (for example specifications, test methods, protocols and reports).
• Periodically review SOPs for compliance with CGMP and revise SOPs, if necessary.
• Execute EQ protocols and set up qualification program for new instruments with some guidance.
• Perform calibration and maintenance of various analytical equipment.
• Assist in preparing documents for ANDA/NDA filing.
• Provide formal/informal mentoring to technicians.

DUTIES AND RESPONSIBILITIES – SECONDARY ROLE:

• Clean laboratory glassware.
• Maintain laboratory in clean and organized condition.
• Order, receive and maintain a record of chemicals and lab supplies.
• Perform regular inspection of chemical storage areas to ensure the proper storage of chemicals and to remove expired chemicals from storage.
• Packaging all samples to be sent out.
• Dispose laboratory organic waste and solid waste timely manner.
• Assist in filing of laboratory documents.