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Quality Specialist I - Job In Katalyst Healthcares & Life
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Quality Specialist I - Chemist

  • Full-Time
  • Wilson, NC
  • Katalyst Healthcares & Life Sciences
  • Posted 3 years ago – Accepting applications
Job Description
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.
Summary of Work:
  • Entry level Chemist (Quality Specialist I) 1-2 years experience, HPLC, Dissolution testing, LIMS and Empower software experience is a perk.
  • Local candidates only and recent graduates are of most interest (BS/MS in Chemistry is mandate)
  • Hours: 7am 5:30 pm (some flexibility but shift is 10.5 hrs w/ 1D2 hr unpaid meal period)
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