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Quality Control Lab Chemist (QC) reports to the TAT Quality Assurance Manager. This is a professional quality position to support the quality assurance activities of our client's radio pharmaceutical Targeted Alpha Therapy (TAT) Program. Initially, this position will assist in developing the QC laboratory operation portions of the Quality Management System to Title 21 CFR 210/211 and ICH Guides. The role will then perform day-to-day QC sampling, testing and recording of radioactive chemicals.
Develop analytical test methods according to ICH - Q2 guidelines for analytical methods (Gamma spectroscopy, Alpha spectroscopy, ICP-MS/OES).
Perform chemical and physical testing of raw materials, in-process materials, and finished products.
Communicate testing results and disposition to QA Director as required
Support data generation and trending of all testing performed
Prepare and review documentation (change controls, specifications, protocols, reports, raw data packages, etc.) pertaining to release, stability studies, method validation and reference standard characterization, etc.
Participate in OOS, NCR, CAPA and Deviation investigations as needed
Assist in preparing regulatory documents and contribute to writing of SOP's as needed.
Support all internal and external audits
Perform daily verification checks of lab equipment such as spectrometers, balances, pH meters etc.
Perform instrument calibration as required.
Participate in ongoing research and development and validation studies.
Perform inventory management of lab materials including reagents, columns, etc.
Review ordering of lab materials including chemicals, solvents, consumable supplies, etc.
Perform and maintain sample log
Be flexible and support departmental needs, as needed
A minimum bachelor’s level degree in Radiochemistry is preferred but will consider a related field.
A minimum of 5 years’ experience in a pharmaceutical industry, (preferable cGMP radiopharmaceutical) with a minimum of 2 years in QC testing.
Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance; preferably, experience in an operational / production radiopharmaceutical facility.
Must have a keen attention to detail with the ability to read, understand requirements such as federal regulations, national codes and standards and interpret these standards into the client's documents and provided guidance to the client's personnel regarding these requirements.
Shall have experience or possess ability to learn, understand and use various lab analysis equipment, quality support software for records retention.
Must demonstrate strong data analysis, troubleshooting and decision-making skills
Operation and testing using various analytical instruments and wet chemistry testing.
Demonstrated experience with laboratory analytical instrumentation operation.
Strong organizational and communication skills, including technical writing, teamwork, and interpersonal skills and display respect and a desire to foster teamwork.
The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.
Job Functions are physical actions and/or working conditions associated with the position.These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. An applicant's ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.
Motor Abilities: Sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds
Repetitive work: Occasional, prolonged
Special Senses: Visual and audio focused work
Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day
Travel required: 0-5%