QC/Production Associate I

SOFIE; Kansas City (MO); Vor Ort; USD 39.000 - 41.000; Vollzeit

Zusammenfassung

SOFIE in Kansas City, MO is seeking a QC/Production Associate I to operate radiosynthesizers for FDG and NaF production, and to run analytical QC equipment.

You will ensure materials and reagents are within expiry, confirm equipment qualification, perform QC procedures, maintain cGMP documentation, and help with inventory management.

This role supports site safety and compliance while collaborating with the Network Operations team; shift is Tuesday through Saturday.

Qualifikationen

• High school diploma required; associates degree preferred.
• Technical experience with computer-controlled automation preferred.
• Proficient in MS Office.
• Ability to work various shifts and weekends.
• Ability to lift ~50 lbs.
• Up to 5% travel.

Aufgaben

• Operate radiosynthesizers for FDG and NaF production per SOPs.
• Ensure materials/reagents are accepted and within expiry.
• Ensure equipment is qualified prior to use.
• Operate synthesis unit per SOPs and assist in maintenance.
• Perform FDG/NaF QC processes and maintain QC equipment.
• Complete cGMP documentation and assist QA.
• Assist with inventory management and reporting.
• Troubleshoot equipment, production, or QC issues with network support.
• Maintain clean and safe working environment and perform radiation safety duties.
• Enter ISO classified areas with proper qualification and monitoring.

Kenntnisse

MS Office Suite

Detail-oriented

Teamwork

Ausbildung

High school diploma

Associates degree in chemistry, engineering, or natural sciences

Jobbeschreibung

Overview

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

• 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.
• 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.

Description

QC/Production Associate I

Title | QC/Production Associate I

Location | Kansas City, MO

Department | Network Operations

Reports To | Facility Manager

Compensation Range | $28 - $30/hr

Work Schedule | Tuesday through Saturday

Overview

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

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.
• 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; associates 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 required.