QC Associate I
Aequor JD ·www.aequor.com
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Technical Responsibilities:
Perform Total Organic Carbon (TOC) and Conductivity testing on equipment cleaning samples utilizing different type of instruments such as the Sievers M9 TOC Analyzer and the Mettler Toledo Sevenexcellence pH/Conductivity Meter
Perform Raw Material tests (wet chemistry and analytical tests) in accordance with different compendia requirements (USP, EP, JP) which include but are not limited to: Appearance, pH, ID reactions of Ions and Functional Groups, ID by FT-IR, HPLC, Osmolality, Color absorption, Titrations.
Compliance Duties:
Executes and reviews fundamental laboratory tasks, as prepare buffers and run assays. Identifies and implements fundamental improvements to lab processes compliance activities. Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs).
Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner. Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately. Maintains and improves lab areas according to predefined standards (5Ss).
Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on compliance topics and scientific principles as needed.
Coordinates work within the team and cross functionally.
Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place.
Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.
Trains other associates and technicians on methods and compliance.
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment. Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance.
1 or more years of GMP experience preferred.
Must be willing to work all shifts including weekend support but primary work hours are during the day.
Bachelor s Degree in a Scientific Discipline
Perform Total Organic Carbon (TOC) and Conductivity testing on equipment cleaning samples utilizing different type of instruments such as the Sievers M9 TOC Analyzer and the Mettler Toledo Sevenexcellence pH/Conductivity Meter
Perform Raw Material tests (wet chemistry and analytical tests) in accordance with different compendia requirements (USP, EP, JP) which include but are not limited to: Appearance, pH, ID reactions of Ions and Functional Groups, ID by FT-IR, HPLC, Osmolality, Color absorption, Titrations.
Compliance Duties:
Executes and reviews fundamental laboratory tasks, as prepare buffers and run assays. Identifies and implements fundamental improvements to lab processes compliance activities. Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs).
Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner. Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately. Maintains and improves lab areas according to predefined standards (5Ss).
Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on compliance topics and scientific principles as needed.
Coordinates work within the team and cross functionally.
Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place.
Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.
Trains other associates and technicians on methods and compliance.
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment. Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance.
1 or more years of GMP experience preferred.
Must be willing to work all shifts including weekend support but primary work hours are during the day.
Bachelor s Degree in a Scientific Discipline
Frequently asked questions
Who is hiring for the QC Associate I role?
Aequor JD is hiring for the QC Associate I position, a Shazamme client. Apply directly on the employer's career site.
Where is the QC Associate I job located?
The QC Associate I role with Aequor JD is based in Fremont, CA, US.
Is the QC Associate I role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the QC Associate I role?
The QC Associate I position is aimed at junior-level candidates.
How do I apply for the QC Associate I 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.