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Job ID : 27505

Location : Wilson, NC

Company Name : AgreeYa Solution Inc.

Job Type : Contract

Industry : Biotech/Pharmaceutical

Salary : $19 - $21  per hour

No. of Positions : 2-4

Required Skills : GMP Or

Benefits : Medical Insurance,Dental Insurance,Vision Insurance,Life Insurance

Job Description :
  • Performs a variety of chemical analysis and GMP reviews 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.  

Summary of Work:

  • Entry-level Chemist (Quality Specialist I) 0-2 years’ experience, HPLC, Dissolution testing,  LIMS and Empower software experience is a perk.  

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    

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, 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 the 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.    

Hours: 7 am – 5:30 pm EST (Mon – Thurs)

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