QC Production Associate

Description: Join our team as a QC/Production Associate I, where you’ll play a key role in producing life-changing drug products and ensuring their quality through hands-on work with advanced radiosynthesizers and analytical equipment. *QC/Production Associate I* *Title *| QC/Production Associate I *Department *| Network Operations *Reports To* | Facility Manager *Compensation | *$27-$30/hr *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. Job Type: Full-time Pay: $27.00 - $30.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Health savings account * Life insurance * Paid time off * Relocation assistance * Retirement plan * Vision insurance Experience: * TLC: 1 year (Preferred) * GC: 1 year (Preferred) * HPLC: 1 year (Required) License/Certification: * RPH License (Preferred) Shift availability: * Overnight Shift (Required) Ability to Commute: * Miami, FL 33134 (Required) Work Location: In person