FTE Quality Specialist I, Chemist
Company: Katalyst Healthcares & Life Sciences
Posted on: November 24, 2022
- Perform all assigned testing in a timely and organized manner
in accordance with cGMP, GLP, DEA and company policies and
- Document all necessary and relevant information in an accurate
and 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
- Communicate openly within the group to provide and gather
information, to optimize the use of resources and to optimize
- Provide training and assistance to other group
- Actively participate in investigations, problem solving and
- 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
- Assist in writing and performing method validations and method
transfers and assist in process validations.
- Perform equipment validations IQs, OQs, PQs, and MQs, if
necessary, provide assistance and technical support to other groups
with chemical testing needs and perform troubleshooting of
analytical methods and instrumentation.
- Perform other related assignments and duties as required and
- The incumbent must have a BA or BS degree in Chemistry or
closely related science . The incumbent must have a BA or BS degree
in Chemistry or closely related science. Prior GxP laboratory
experience of six months - two years is highly preferred.
- 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 have a familiarity with
computerized laboratory environment.
- Supervisory Responsibilities (if Applicable)
- There are no positions reporting to this position.
- Minimum required education, experience, knowledge, skills and
abilities are included in the posting. The position will be filled
at the level commensurate with the successful candidate's
education, experience, knowledge, skills, and abilities.
- The job description is not an exhaustive list of all functions
that the employee may be required to perform, and the employee may
be required to perform additional functions. Additionally, the
company may revise the job description at any time.
Keywords: Katalyst Healthcares & Life Sciences, Wilson , FTE Quality Specialist I, Chemist, Other , Wilson, North Carolina
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