QC Production Associate I

SOFIE; Houston (TX); Presencial; USD 42.000 - 66.000; Jornada completa

Descripción de la vacante

SOFIE in Houston, TX is seeking a QC/Production Associate I to operate radiosynthesizers for drug product production and run QC analytical equipment. You will ensure materials meet SOPs, maintain equipment qualification, and support cGMP documentation.

The role requires attention to detail, teamwork, and the ability to lift up to 50 lbs, with schedule flexibility including weekends.

Formación

• High school diploma required; associate's degree in chemistry, engineering, or natural sciences preferred.
• Technical experience with computer-controlled automation preferred.
• Efficient in the use of MS Office Suite required.
• Ability to work various shifts and weekends required.
• Detail-oriented, accountable, patient, organized, and team-oriented.
• Ability to lift ~50 lbs. required.

Responsabilidades

• Operate radiosynthesizers for FDG and NaF production following SOPs.
• Operate QC equipment and perform quality control per SOPs.
• Ensure materials and reagents are within expiry and properly accepted.
• Maintain qualification and calibration of equipment prior to use.
• Assist with inventory management and reporting.
• Complete cGMP documentation and participate in incident investigations.

Conocimientos

Detail oriented

Team collaboration

Communication skills

Physical strength

Educación

High school diploma

Associate's degree in chemistry/engineering/natural sciences

Herramientas

MS Office Suite

Descripción del empleo

Title | Quality Control (QC) / Production Associate I
Location | Houston/TX
Department | Network Operations
Reports To | Facility Manager

Overview

The QC/Production Associate I will operate the radiosynthesizers for the production of drug products, as well as operate analytical equipment for the quality control of drug products.

Essential Duties and Responsibilities

• Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):


• Ensure all materials/reagents are accepted according to SOPs and within expiry


• Ensure all equipment is appropriately qualified prior to use


• Operate the synthesis unit according to SOPs


• Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit


• Perform FDG and NaF quality control (QC) processes according to SOPs:


• Assist with basic maintenance of QC equipment


• Ensure all equipment is appropriately calibrated and qualified prior to use


• Operate the QC equipment according to SOPs


• Ensure completion of applicable cGMP documentation.


• Assist with inventory management:


• Maintain production/QC/cleaning supply levels as appropriate


• Assist with inventory reporting


• Perform material acceptance according to SOPs


• Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.


• Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility Engineer.


• Maintain a clean and safe working environment.


• Perform radiation safety duties according to SOFIE's Corporate Radiation Compliance Program and site licensing requirements.


• Maintain all qualification and validation requirements for entering ISO classified area.


• Clean classified and non-classified areas according to SOPs.


• Perform environmental monitoring of classified areas according to SOPs.


• Report manufacturing metrics into data repository as required.


• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.


• Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:




• Investigations


• Corrective and Preventative Actions


• Deviations


• Out of Specifications


• No or Atypical Yields


• Manufacturing and QC Records


• Logbooks





• Attend internal meetings as required.


• Other assigned duties as required.

Qualifications

• High school diploma required; associate's degree in chemistry, engineering, or natural sciences preferred.


• Technical experience with computer-controlled automation preferred.


• Efficient in the use of MS Office Suite required.


• Ability to work various shifts and weekends required.


• Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.


• Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.


• Ability to lift ~50 lbs. required.


• Up to 5% travel is required.