QC/Production Associate I

SOFIE Inc.; Kansas City (MO); Sur place; USD 39 000 - 41 000; Plein temps

Résumé du poste

SOFIE Inc. in Kansas City, MO seeks a QC/Production Associate I to operate radiosynthesizers for drug product and analytical equipment for quality control. You will perform synthesis and QC activities per SOPs and assist with inventory and documentation in a fast-paced environment.

The role requires a high school diploma (associates preferred), MS Office proficiency, ability to lift 50 lbs, weekend shifts, and up to 5% travel. Training provided.

Qualifications

• High school diploma required; associate degree in chemistry, engineering, or natural sciences preferred.
• Technical experience with computer-controlled automation preferred.
• Efficient in 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 lift ~50 lbs. required.
• Up to 5% travel required.

Responsabilités

• Operate radiosynthesizers for FDG and NaF production per SOPs.
• Ensure materials/reagents are within expiry and qualified.
• Ensure equipment is qualified prior to use and perform routine maintenance.
• Operate QC equipment and perform QC processes per SOPs.
• Assist with inventory management and reporting.
• Communicate with local and Network support to troubleshoot issues.
• Perform basic computer-controlled cyclotron operations under supervision.
• Maintain clean, safe work environment and complete cGMP documentation.

Connaissances

MS Office Suite

Attention to detail

Team environment

Formation

High school diploma

Associate degree in chemistry/engineering/natural sciences

Description du poste

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 andNaFsynthesis 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 andNaFquality 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/cleaningsupply levels as appropriate
• Assist with inventory reporting
• Perform material acceptanceaccordingto SOPs
• Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
• Perform basic computer-controlled cyclotron operations for FDG andNaFproduction 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.