Quality Specialist - Chemist

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: May 16, 2023

Job Description:

Job Description

Responsibilities:

• Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
• Document all necessary and relevant information in an accurate and 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.
• ctively 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.
• ssist in writing and performing method validations and method transfers and assist in process validations.
• Perform equipment validations IQs, OQs, PQs, and MQs, if necessary, provide assistance and technical support to other groups with chemical testing needs and perform troubleshooting of analytical methods and instrumentation.
• Perform other related assignments and duties as required and assigned. Requirements:
  • The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 0 to 2 years of laboratory experience.
  • 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.

Keywords: Katalyst Healthcares & Life Sciences, Wilson , Quality Specialist - Chemist, Other , Wilson, North Carolina