Overview
Position Objective: Responsible for conducting finished goods and raw material sampling and testing within an ISO accredited laboratory environment. Essential functions include Pharmacopeia testing, UHPLC, ICPMS analysis, and a strong knowledge of both basic and advanced analytical techniques. Ensures compliance with in-house and external specifications and standards. Actively leads data collection, trend analysis, investigation, and improvement processes.
Responsibilities
* Serves as a subject matter expert in analytical finished goods release testing, ensuring timely and efficient performance in accordance with standard operating procedures.
* Lead and troubleshoot technical and instrumental queries across the analytical chemistry department.
* Proactively collaborate with Production, Technical, and Manufacturing teams to resolve quality-related issues arising from customer complaints and internal incidents. Facilitate investigation and resolution of related quality issues.
* Identify and implement opportunities for improvement across the quality department and operational facility.
* Point of contact for Junior lab operators
* Exercise independent decision-making and initiative where appropriate.
* Perform statistical analysis to review trends in data and implement improvements.
* Exercise considerable latitude in determining technical objectives and solutions to complex problems.
* Constantly strive to enhance efficiency in procedures and processes without compromising quality.
* Review and approve testing assigned to new, existing and future products from a quality perspective.
* Perform other related duties as required and/or assigned.
Education
Requires a bachelor's degree in Chemistry or a related subject area.
Experience
Extensive analytical experience with a minimum of 5 years in a related environment. Demonstrates excellent working knowledge of scientific principles. Experience operating and troubleshooting HPLC/UHPLC and ICP-MS/OES systems, method development and validation experience are essential.
Qualifications
Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and effectively interact with all levels of the company. Effective communication skills and the ability to collaborate with internal and external development team members are essential.
Contacts
Will liaise extensively with all other departments within the operational department. Customer and external lab communication is also expected within this role.
Working Conditions
Work is conducted in an analytical lab environment. May be required to perform raw material and WFI sampling, which will involve the movement of boxes and pallets.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting
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