SOFIE · 1 month ago
QC/Production Associate I
Dallas, TX
Full-time
Onsite
New Grad, Entry LevelSOFIE is a company focused on producing life-changing drug products. The QC/Production Associate I will operate radiosynthesizers and analytical equipment to ensure the quality of drug products while maintaining compliance with SOPs and cGMP documentation.
BiotechnologyLife ScienceManufacturingMedical DevicePharmaceutical
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
Qualification
Required
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
Up to 5% travel required
Preferred
Associates degree in chemistry, engineering, or natural sciences preferred
Technical experience with computer-controlled automation preferred
Company
SOFIE
SOFIE is a molecular imaging company focused on empowering people with new PET technologies.
Founded in 2008
501-1000 employees
H1B Sponsorship
SOFIE has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$44.6MKey Investors
Trilantic North AmericaJubilant BiosysNational Institutes of Health
2024-01-28Private Equity
2020-11-04Series C· $27.4M
2018-10-05Grant· $5M
Leadership Team
Patrick Phelps
President, CEO, & Board Member, Co-Founder
Recent News
2026-01-15
2025-12-29
Company data provided by crunchbase