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Technical Data Reviewer

Company: Aequor Technologies LLC
Location: Rocky Mount
Posted on: January 23, 2023

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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