Technical Data Reviewer
Company: Aequor Technologies LLC
Location: Rocky Mount
Posted on: January 23, 2023
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Job Description:
Job Title: Technical Data Reviewer
Minimum experience:3+ years
Onsite - will need to adhere to return to site policy
Duration: Assignments will be for 6-months with the possibility of
extension up to 12-months
ROLE 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 5 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.
REQUIRED QUALIFICATIONS:
Minimum of 1 year data review experience with minimum 5 yrs Lab
Experience in pharmaceutical manufacturing environment.
Minimum of 4-5 years of experience reading and interpreting
chromatographic data.
ICP-MS Experience Preferred
Required Technical Experience:
-HPLC basic experience (AA/ICP-MS)
-Empower3 Experience
-Chromatography Knowledge
-cGMP
Day 2 Day:
-HPLC
-GC
-AA/ICP-MS
-Data Review
Keywords: Aequor Technologies LLC, Rocky Mount , Technical Data Reviewer, Other , Rocky Mount, North Carolina
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