QA Chemist-Technical Data Reviewer
Company: Unicon Pharma
Location: Rocky Mount
Posted on: January 9, 2021
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Job Description:
Summary: The CQ Technical Data Reviewer reviews data from
physical and dimensional testing of commodities, wet chemical
techniques and instrumental analyses. Included in this review are
visual evaluations, titrations, pH measurements, AA, HPLC, GC and
UV/Vis among other analyses. In addition to data review, this
individual could be responsible for preparing solutions, performing
analyses, as well as recording and processing data in accordance
with DEA, FDA, and ICH guidelines, as needed. Role
Responsibilities: Functions as a dedicated data reviewer for the
Chemical Quality Lab. Prioritizes data review and testing with
guidance from Data Coordinator or supervisor. Assists in monitoring
laboratory metrics associated with turnaround goals. As needed,
prepares solutions required for testing, performs analysis, records
data according to cGMPs, performs calculations and enters results
into LIMS system. Provides support to assure lab safety and
compliance -either through safe use of chemicals and/or the
recognition of DEA, FDA, OSHA, and ICH compliance issues. Basic
Qualifications: Bachelor of Science in Life Science (e.g.
Chemistry, Biology, Microbiology, etc.) Minimum of 4 years of
experience in a Quality Control or R&D laboratory and
experience with a wide variety of analytical techniques (e.g.,
HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET,
antibiotic potency, sterility, etc.). Knowledge of cGMPs and
regulations outside of the US. Good communication, organization and
computer skills are required. Knowledge of LIMS, Empower, and
Microsoft Office programs is desired. Preferred Qualifications:
Minimum of 1 year data review experience in pharmaceutical
manufacturing environment. Minimum of 2 years of experience reading
and interpreting chromatographic data. ICP-MS experience
Physical/Mental Requirements: Able to: stand for up to 8 hours, sit
for up to 8 hours, walk, climb stairs, respond to visual warning
indicators, respond to audible warning indicators, respond to color
or special visual indicators, wear specialized protective clothing
(lab coat, safety glasses, gloves, face shield/goggles, apron),
perform repetitive use of upper extremities.
Keywords: Unicon Pharma, Rocky Mount , QA Chemist-Technical Data Reviewer, IT / Software / Systems , Rocky Mount, North Carolina
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