QC Chemistry
Aequor JD ·www.aequor.com
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Quality Control Chemistry is responsible for qualification of equipment, software and authoring the documents including qualification, SOP etc. The candidate will perform bioassays, analytical testing, rheology evaluations, and statistical data analysis to ensure product quality, safety, and compliance with regulatory standards. Experience with Hamilton systems, statistical software, and rheology, CCIT, FT-IR instrumentation is preferred. Additional functions include method validation/verification, tech transfers etc. in the Quality Control laboratory.
Description: Perform routine and non-routine bioassay testing for raw materials, in-process samples, stability samples, and finished products.
Operate and maintain Hamilton Microlab star automated liquid handling systems for bioassay preparation and sample processing.
Familiar with BioStat, PLA, SoftMAx Pro etc statistical software for Hamilton bioassay testing.
Conduct qualification activities for laboratory instrumentation including but not limited to Hamilton, Rheometers, FT-IR, CCIT, UV Spectrophotometer etc.
Prepare technical reports, SOPs, protocols for qualification of instruments and investigation documentation in compliance with cGMP, FDA, and ICH guidelines.
Support method qualification, validation, and transfer activities.
Perform instrument calibration, troubleshooting, maintenance, and documentation.
Work effectively with others to achieve shared goals and perform weekly trending meetings for qualification/upgradation activities.
Interact with external vendors on technical matters requiring coordination for qualification activities.
Work independently with minimal supervision and direction in compliance with cGMPs.
Practice safe work habits and adhere to ThermoFisher's safety procedures and guidelines.
HSE
It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
The individual must support site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.
REQUIREMENTS
Basic Qualifications
Bachelor's Degree in Life Sciences discipline and 6-8 years' experience in cGMP lab environment, or a
Master's Degree in Life Sciences discipline and 5 years' experience in cGMP lab environment.
Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems
Scientific technical writing ability.
Preferred Qualifications
Hands-on experience with:
BioAssay (Hamilton Microlab Star) with BioStat, PLA or SoftMax Pro software.
Rheometers, FT-IR, UV Vis Spectroscopy and CCIT.
Experience with instrument and software Qualification.
Knowledge of lab-based data management systems.
Familiarity with FDA and USP global compendia requirements.
#TechKV
Description: Perform routine and non-routine bioassay testing for raw materials, in-process samples, stability samples, and finished products.
Operate and maintain Hamilton Microlab star automated liquid handling systems for bioassay preparation and sample processing.
Familiar with BioStat, PLA, SoftMAx Pro etc statistical software for Hamilton bioassay testing.
Conduct qualification activities for laboratory instrumentation including but not limited to Hamilton, Rheometers, FT-IR, CCIT, UV Spectrophotometer etc.
Prepare technical reports, SOPs, protocols for qualification of instruments and investigation documentation in compliance with cGMP, FDA, and ICH guidelines.
Support method qualification, validation, and transfer activities.
Perform instrument calibration, troubleshooting, maintenance, and documentation.
Work effectively with others to achieve shared goals and perform weekly trending meetings for qualification/upgradation activities.
Interact with external vendors on technical matters requiring coordination for qualification activities.
Work independently with minimal supervision and direction in compliance with cGMPs.
Practice safe work habits and adhere to ThermoFisher's safety procedures and guidelines.
HSE
It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
The individual must support site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.
REQUIREMENTS
Basic Qualifications
Bachelor's Degree in Life Sciences discipline and 6-8 years' experience in cGMP lab environment, or a
Master's Degree in Life Sciences discipline and 5 years' experience in cGMP lab environment.
Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems
Scientific technical writing ability.
Preferred Qualifications
Hands-on experience with:
BioAssay (Hamilton Microlab Star) with BioStat, PLA or SoftMax Pro software.
Rheometers, FT-IR, UV Vis Spectroscopy and CCIT.
Experience with instrument and software Qualification.
Knowledge of lab-based data management systems.
Familiarity with FDA and USP global compendia requirements.
#TechKV
Frequently asked questions
Who is hiring for the QC Chemistry role?
Aequor JD is hiring for the QC Chemistry position, a Shazamme client. Apply directly on the employer's career site.
Where is the QC Chemistry job located?
The QC Chemistry role with Aequor JD is based in Ridgefield, NJ, US.
What does the QC Chemistry role pay?
Aequor JD lists the QC Chemistry role at USD 60–70 per hour.
Is the QC Chemistry role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the QC Chemistry role?
The QC Chemistry position is aimed at mid-level candidates.
How do I apply for the QC Chemistry role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.