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Floating QC/Production Associate III

Company: SOFIE
Location: Romeoville
Posted on: November 23, 2021

Job Description:

The QC/Production Associate III is a leader in QC and/or Production at SOFIE Network sites for the production and/or quality control of drug products. They will operate and maintain the radiosynthesizers for the production of drug product, as well as operate and maintain analytical equipment for the quality control of drug product, over all drug products made at the facility. They will also aid the Network Facility Managers in training and mentorship of QC/Production personnel.

Essential Duties and Responsibilities

Travel to various network locations in order to provide:Shift coverage where needed
Provide training and mentorship of site QC/Production personnel
Examine site trends and identify areas for QC/Production improvement
Address other site-specific issues/special projects as assigned

Proficient at the manufacturing and quality control of multiple products on multiple platforms according to SOFIE Standard Operating Procedures (SOPs):Demonstrate understanding of theoretical principles of radiosynthesis and quality control
Ensure all materials/reagents are prepared/accepted according to SOPs and within expiry
Ensure all equipment is appropriately qualified prior to use
Operate the platforms according to SOPs
Perform routine maintenance and qualification of equipment
Perform troubleshooting and emergency maintenance of equipment

Ensure completion of applicable cGMP documentation.

Perform inventory management:

Maintain production/QC/cleaning supply levels as appropriate
Perform 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 multiple products' 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:


Corrective and Preventative Actions
Out of Specifications
No or Atypical Yields
Manufacturing and QC Records


Attend internal meetings as required.
Other assigned duties as required.


High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.
4-years' experience in radiopharmaceutical manufacturing and quality control required.
Technical experience with computer-controlled automation required.
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.
50-75% travel required.

Keywords: SOFIE, Chicago , Floating QC/Production Associate III, Professions , Romeoville, Illinois

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