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Quality Specialist I Chemist

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Company :
Katalyst Healthcares & Life Sciences

Location :
Wilson, North Carolina

Expiry Date :
Tue, 06 Apr 2021 23:59:59 GMT

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Description :
Job Details Full-time | Part-time | Contract$20 – $23 an hour4 hours ago Qualifications – Spectroscopy – FDA regulations – Laboratory experience – Computer literacy – Bachelor’s degree Full 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 ition 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 Types: Full-time, Part-time, Contract Salary: $20.00 – $23.00 per hour Schedule: – 8 hour shift Experience: – Chemist: 1 year (Required) – HPLC, GCDissolution, Automation, or Spectroscopy: 1 year (Required) – cGMP, GLP, DEA: 1 year (Required) Contract Length: – More than 1 year Work Location: – One location Work Remotely: – No Show full job description Quick