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Chemist/Quality Specialist
Ref No.: 18-05332
Location: Herndon, North Carolina
Job Title: Chemist/Quality Specialist
Location: Wilson, NC 27893
Duration: 6 Months

40 Hours per week; Monday to Friday; 09:00 AM to 05:00 PM

Qualify On: Summary of Work:
  • 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

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.

Tech skills:
  • 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