Quality Control Chemist II

Radiomedix, Inc.•Humble, TX

2d•Onsite

About The Position

Ensures quality control efforts are performed in accordance with established chemistry, manufacturing, and controls specifications for Ga68 generators and upcoming projects in the pipeline. This role involves conducting analytical/quality control testing for API and Drug products to ensure safety, following pertinent Quality Control procedures, and performing analytical testing with proficiency in various equipment. The position also includes setting up and maintaining laboratory equipment, supporting radiochemical process development, ensuring methods conform to cGMP, and assisting in the development of procedures and reports. Responsibilities extend to testing incoming materials, managing chemicals, training new QC employees, and coordinating third-party testing. Additionally, the role involves analytical method development for radiopharmaceuticals/API, writing SOPs, and performing radiation safety duties such as facility surveys, instrument calibration, and waste assessment.

Requirements

At least 2-3 years of QC experience in biotech, pharma, or cGMP.
Proficiency in equipment e.g. HPLC, TLC, ICPMS, HPGE/Gamma Spec.
Ability to meet the physical demands of the job (standing for long periods of time, lifting heavy loads of up to 40 pounds etc.).
Ability to function and maneuver within the work environment without placing self, the product or others at risk.
Requires physical strength and dexterity with the ability to climb on ladders and up on equipment for environmental service and maintenance responsibilities.

Nice To Haves

Experience with analytical method development for radiopharmaceuticals/API using instruments such as HPLC, GC, TLC, and ICP-MS.

Responsibilities

Conducts analytical/quality control testing in accordance with cGMP (21 CFR 211) for API and Drug products to ensure safety for the patient/end user.
Follows pertinent RadioMedix Quality Control procedures for e.g. Identity testing, radiochemical purity, radionuclidic purity, endotoxin and sterility.
Preforms analytical testing with proficiency in equipment e.g. HPLC, TLC, ICPMS, HPGE/Gamma Spec.
Completes and maintains appropriate documentation required by federal and state agencies.
Sets up and maintains automated chemistry modules and laboratory equipment.
Supports RadioMedix’s development of radiochemical processes.
Ensures Quality Control methods are in conformity with cGMP.
Assist in the development of procedures, test reports, operating procedures, and maintenance procedures for new or updated processing equipment.
Drafts pertinent protocols, reports and documentation to support API and Drug Product.
Tests materials upon incoming receipt if required according to RadioMedix release specifications.
Ensures chemicals on site are properly managed in appropriate conditions with appropriate documentation e.g. Safety Data Sheets.
Trains new QC employees.
Coordinates third party testing of raw materials if required.
Development of procedures in the quality control of radiopharmaceuticals/API using a variety of instruments such as HPLC, GC, TLC, and ICP-MS.
Develop and improve analytical methods used in assessing the radiochemical attributes of the company products.
Write necessary SOPs, Validation Protocols and Validation Report.
Supports wipes and surveys of the facility to ensure state of control.
Provides basic support and supervision for ensuring calibration of all radiation instrumentation.
Performs radiation safety duties to assure compliance with all regulations.
Assesses the nuclear waste characteristics of the group’s chemical processes to support regulatory and waste classification exercises.
Be self-motivated and able to work as a team member when needed.
Ensures a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.
Follows and promote on-the-job safety expectations, including wearing proper Personal Protective Equipment (PPE) and following cGMP rules and guidelines in all designated areas.