QC Chemist I & II
Company: ProStaff Solutions Inc
Location: New Brunswick
Posted on: May 8, 2022
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Job Description:
ProStaff Solutions is looking for QC Chemist I & II to work with
a pharmaceutical company in New Brunswick, NJ. Direct Hire Job
Summary: Perform analytical testing for raw materials and various
drug products in different dosage forms such as tablets, capsules,
transdermal patch etc. Operate instruments such as HPLC, GC,
Dissolution, UV-Vis, FTIR, Particle Size Analyzer, KF Titrator,
Oven etc. Area of Responsibility Performs tests and analysis of raw
materials, bulk and finished products, scale-up samples, process
validation samples, cleaning validation samples, and stability
samples using instrumentation such as HPLC, UPLC, GC, UV-Vis, FTIR,
dissolution apparatus, particle size analyzer etc. Responsible for
the timely execution of lab analysis as directed. Assists in
conducting analytical method validation and method transfer
activities, as directed. Concurrent documentation of all the raw
data, observations in the notebooks or equivalent electronic system
as per Good Documentation Practices. Provides training and
mentoring to less experienced chemists, as needed. Be vigilant to
any difficulties, undesirable/unacceptable problems in analytical
method execution, chromatography, and data integration and keep the
supervisor/manager informed of such issues. Help lower level
chemist to resolve technical issues. Compile the analytical data
and notify the results to supervisor/manager. Adhere to safety, DEA
procedures and department SOPs. Keep the working place clean and
tidy. Supports systems to ensure the successful completion of
Departmental goals and objectives. Assists Metrologists in
laboratory equipment qualifications, calibrations and preventative
maintenance programs, as needed. Assists in preparing technical
documentation including test reports, analytical test procedures,
and change controls, investigations and CAPAs as needed. Manages
USP reference standards and the qualification of secondary
standards, as needed. Works to ensure compliance with cGMP's and
the site operating procedures under the direction of senior staff
or laboratory management. Works independently and the primary job
functions require independent judgment. Participates in a
leadership capacity, in one or more of several laboratory
committees, (e.g. Safety, Instrumentation, GMP, SOP etc.) Performs
other duties as assigned. Education or Equivalent: Minimum BS or
equivalent degree in Chemistry or related scientific discipline.
Experience: 5+ years of experience in pharmaceutical analytical
laboratory People based qualities: Good communication and writing
skills, respect to others, positive attitude, team work, quick
learner. Requirements and Qualifications: Familiarity with
analytical instrumentation theory such as HPLC, GC, FTIR, UV and
practice. Familiarity with wet chemistry techniques. Ability to
train junior chemists. Working knowledge of Microsoft Office
Applications. Knowledge of ICH and FDA regulatory guidance. Must be
familiar with cGMP/GLP concept or practices for analytical
laboratories and EHS/OSHA safety regulations. Familiar with of USP
dissolution apparatus 1 and 2. Excellent written and verbal
communication skills.
Keywords: ProStaff Solutions Inc, New Brunswick , QC Chemist I & II, Other , New Brunswick, New Jersey
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