QC/Production Associate I

Sofie Co.•Gilroy, CA

10d•$30 - $32•Onsite

About The Position

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 radio synthesizers and analytical equipment. 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.

Requirements

High school diploma 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

Nice To Haves

associates degree in chemistry, engineering, or natural sciences preferred
Technical experience with computer-controlled automation preferred

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