Chemist

• Performs a variety of chemical analysis and GMP reviews of raw materials, packaging components, ancillary solutions, in-process samples, finished product, and stability samples in accordance with cGMP, GLP, DEA, and company policies and procedures.
• Assists in writing and performing method validations and method transfers.
• Assists in process validations.
• Conducts equipment validations IQs, OQs, PQs, and MQs, if necessary.
• Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation.  

Summary of Work:

• Entry-level Chemist (Quality Specialist I) 0-2 years’ experience, HPLC, Dissolution testing,  LIMS and Empower software experience is a perk.  

Necessary Knowledge, Skills, and Abilities

• Must demonstrate comprehension of at least one analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with cGMPs and FDA requirements.
• Must pass an internal GMP Training course and be computer literate    

Primary Responsibilities

• Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA, and company policies and procedures.
• Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Operate and maintain all analytical instrumentation and equipment as per established procedures.
• Write, revise, develop and evaluate operational and maintenance procedures.
• Communicate openly within the group to provide and gather information, optimize the use of resources, and to optimize efficiency.
• Provide training and assistance to other group members.
• Actively participate in investigations, problem-solving, and troubleshooting.
• Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
• Re-stock chemicals and consumables used in the analysis.
• Prepare and present data summaries (written and oral) as necessary.
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
• Performs other related assignments and duties as required and assigned.  

Education and Experience Requirements

• The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 0 – 2 years of laboratory experience.    

Hours: 7 am – 5:30 pm EST (Mon – Thurs)