Primary responsibility is to complete documentation and analytical testing of raw materials, in-process materials, stability samples, finished products and product development in a timely manner, while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA. 

• Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28, 21CFR211.170 and ALCOA principals.
• Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
• Follow all DEA (Drug Enforcement Agency) regulations per laboratory SOPs.
• Perform analytical testing of raw materials, in-process materials, stability samples, finished products and product development products using different analytical techniques in compliance with written, approved methods.
• Document all performed analysis as per cGMP, USFDA and 21CFR211.194 guidelines. Maintain laboratory records including notebooks, logs, and other pertinent documentation in compliance with cGMP, SOPs, and good laboratory documentation guidelines. 
• Operate, Calibrate, Qualify, or perform Preventive maintenance and routine trouble shooting on analytical instruments such as UPLCs, HPLCs, GCs, AAS, UV/Vis spectrophotometers, Dissolution apparatus, Laser Diffraction Particle Size analyzers, etc. as assigned (if trained).
• Ensure all instruments are qualified, and calibrated before each use.
• Ensure all instruments are maintained, cleaned and used appropriately.
• Evaluate existing, as well as verify and validate new analytical methods of drug products and drug substance as per FDA, USP and ICH guidelines.
• Research and gather information in a timely manner.
• Prepare, label, organize and maintain files.
• Follow all SOPs.
• Comply with FDA guidelines/Company Policies of Data Integrity
• Other duties as assigned or delegated

N/A

Education Requirement

Specialization (If any)

BS Chemistry or related science field preferred

N/A

N/A

N/A

Experience Requirement

N/A

Number of Years

(Minimum to Maximum)

N/A

Technical competencies

·         Working knowledge of HPLC, UPLC, GC Dissolution, AA, UV spectrophotometers

·         Aptitude for application of analytical methods

·         Skilled in laboratory techniques

·         Good verbal and written English

·         Excellent interpersonal and communication skills