QC Associate II

Duties

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.

Skills

Two (2) or more years of experience in cGMP regulated industry or equivalent.