Performs a variety of chemical analysis and GMP review 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.
- 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, to 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 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. (This can be academic as well)
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.