QC Data Specialist from Joulé

Job Title:  QC Data Specialist
Location:  Remote
Schedule / Hours:  Part Time, 10 - 15 hours per week (hours will likely increase in the future)
Type:  Contract - 6 - 9 months with potential to extend and convert temp to perm
Compensation: up to $35 per hour pending experience

Responsibilities
Quality Control Assistant Manager will support analytical testing conducted at various contract research organizations under minimal guidance of a supervisor.

• Supports team for method validation and transfer, release and stability testing for the analysis of drug substances and finished products at Contract Research or Manufacturing Organizations in accordance with cGMP regulations, established protocols, and applicable SOPs

• Reviews all tests results, raw data, verifies calculations including electronic data generated in support of testing of raw materials, in-process, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), water determination by KF, and tests according to the in-house monographs and USP generated at contract laboratories

• Ensures compliance with analytical methods during testing

• Reviews method validation / transfer protocols and reports for data accuracy per raw data

• Monitors status of testing; prepares statements noting deficiencies with the analytical data set or notebooks for correction and reports deficiencies to the Team and contract labs

• Compiles data from raw data packages to batch analysis and stability tables using templates, QC data for regulatory submissions.

• Archives documents per company SOP

• Other duties as assigned by his/her supervisor

• Participation in occasional face-to-face meetings in the NYC office a plus

 Requirements

• Bachelor’s degree in chemistry or related field

• 5-10 years of relevant industry experience in Quality Control.

• Previous experience using all types of analytical instrumentation, software, and tests performed in the lab, including HPLC, GC, Dissolution, FT-IR, KF etc. testing required.

• Previous experience with conducting analytical data review as peer or supervisor reviewer is a must

• In-depth knowledge of cGLP / GMP; applicable FDA and ICH guidances a must

• Familiar with USP and other compendia

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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