· 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.
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
· Supervisory Responsibilities (if Applicable)
· There are no positions reporting to this position.
Job Type: Contract
- 10 Hour Shift
- Monday to Friday
- Chemist: 1 year (Required)
- Pharma Industry: 1 year (Required)
- Bachelor's (Required)