Pharma- Chemist

Job Summary:

· 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.

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, 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

Schedule:

  • 10 Hour Shift
  • Monday to Friday

Experience:

  • Chemist: 1 year (Required)
  • Pharma Industry: 1 year (Required)

Education:

  • Bachelor's (Required)

Work Remotely:

  • No