QC/Production Associate I

About the role

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

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.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
• 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; 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.
• 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.