Company: LanceSoft Inc
Posted on: November 25, 2022
Title: FTE Quality Specialist I, Chemist
Location: Wilson NC 27893
Duration: Direct Hire/ Permanent Position
- The Quality Specialist I, Chemist is responsible for supporting
the operations and manufacturing process by performing routine and
non-routine analytical testing and GMP review in support of the
analysis of raw materials, packaging components, ancillary
solutions, in-process samples, finished product method development
and/or transfers, cleaning/process validations, and stability
samples. Will follow standard procedures in accordance with cGMP,
GLP, DEA and company policies and procedures.
- 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
Education and Experience Requirements
- 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.
- 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,
- 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
Keywords: LanceSoft Inc, Wilson , Chemist, Other , Wilson, North Carolina
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