Quality Specialist Chemist
Katalyst Healthcares & Life Sciences
Wilson, North Carolina
Expiry Date :
Mon, 16 Nov 2020 23:59:59 GMT
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ContractEstimated: $42,000 – $59,000 a year1 hour ago
– FDA regulations
– Laboratory experience
– Computer literacy
– Bachelor’s degree
Full Job Description
– 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.
– 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
Job Type: Contract
– 8 hour shift
– Bachelor’s (Preferred)
– Laboratory Experience: 1 year (Preferred)
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