Overview

Develops, establishes and maintains equipment calibration and qualification methodologies, systems, and practices that meet customer and regulatory requirements. Identifies magnitude of error sources contributing to uncertainty of results to determine reliability of measurement process in quantitative terms. Redesigns or adjusts measurement capability to minimize errors. Develops and enhances calibration methods and techniques based on scientific principles, performs technical analysis of measurement problems, and accuracy and precision requirements. Assists engineering, quality, and laboratory personnel in design, manufacture, evaluation, and calibration of measurement standards, instruments, and test systems to ensure selection of approved instrumentation. Advises others on methods of resolving measurement problems and perform training on other metrology personnel.

Responsibilities

• Performs calibration and maintenance of analytical instruments as required.
• Performs equipment troubleshooting and repair.
• Implements and revises calibration, maintenance and qualification procedures by employing various analytical techniques and instruments.
• Records, reports and reviews calibration results and documentation from in house or vendor; prepares documentation in compliance with regulatory requirements.
• Performs calibration and qualification testing in compliance with cGMP and current safety regulations.
• Performs training and provide technical support to others analysts or metrology staff.
• Executes equipment qualification protocols.
• Writes, revises and implements procedures, protocols, qualification, validation, and deviation reports
• Communicate with vendors for equipment quotation and generate equipment purchase requisition.
• Completes any other duties assigned by Metrology/QE management as required.

Qualifications

Competencies:

Education / Experience:

Requires a body of knowledge of principles, procedures, methods and techniques in a specialty, including analytical chemistry. Minimum of Bachelor's degree in chemistry or related field with seven years of appropriate professional experience; or Master degree in chemistry or related field with three years of appropriate professional experience; or Ph. D degree in chemistry or related field. Broad knowledge of scientific principles and methods, analytical methods including chromatographic analysis (i.e. HPLC, GC, Dissolution). Where appropriate the candidate must have broad knowledge of USP related to equipment calibration and qualification. Good verbal and written communication skills in English. Must be highly organized and able to work under pressure. Must have strong interpersonal and leadership skills. Must be computer literate with knowledge in all Microsoft business applications. A strong background in scientific software such as Waters Corp. Empower and LIMS is a plus.

Judgment / Decision Making:

Under general direction toward broad assignments with periodic reviews. Duties performed within a framework of departmental or functional protocol requiring a high degree of original thinking.

Work Environment:

A laboratory environment with exposure to chemicals, acids, caustics, fumes, heat and electrical current.

Physical Demands:

Visual acuity and manual dexterity required to operate computer, analytical instrumentation, and review documents.