QC​/Production Associate

QC/Production Associate I

Department:
Network Operations

Reports to:

Facility Manager

The QC/Production Associate I will operate radio synthesizers for the production of drug product and operate analytical equipment for 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 and maintain it.
• Operate the synthesis unit according to SOPs and learn the operational principles and assist in routine maintenance.
• 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, assist with inventory reporting, perform material acceptance.
• 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 on investigations, corrective & 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.

• 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 able to work in a team environment required.
• Professional communication skills with colleagues and customers; excellent attention to detail; dependable and responsible in a fast‑paced, highly technical environment required.
• Ability to lift ~50 lbs. required.
• Up to 5% travel required.

Entry level

Full‑time

Marketing, Public Relations, and Writing/Editing

Pharmaceutical Manufacturing

Miami, FL $40,000.00‑$55,000.00

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