Quality Control (QC) / Production Associate I (Chemist) I
Company: SOFIE
Location: Sterling
Posted on: May 28, 2023
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Job Description:
Title - Quality Control (QC) / Production Associate I (Chemist)
ILocation - Sterling, VADepartment - Network OperationsReports To -
Facility ManagerOverviewThe 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.Essential Duties and ResponsibilitiesPerform FDG and NaF
synthesis according to SOFIE Standard Operating Procedures
(SOPs):Ensure all materials/reagents are accepted according to SOPs
and within expiryEnsure all equipment is appropriately qualified
prior to useOperate the synthesis unit according to SOPsLearn the
basic operational principles of the synthesis unit and assist in
routine maintenance of the synthesis unitPerform FDG and NaF
quality control (QC) processes according to SOPs:Assist with basic
maintenance of QC equipmentEnsure all equipment is appropriately
calibrated and qualified prior to useOperate the QC equipment
according to SOPsEnsure completion of applicable cGMP
documentation.Assist with inventory management:Maintain
production/QC/cleaning supply levels as appropriateAssist with
inventory reportingPerform material acceptance according to
SOPsCommunicate 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:InvestigationsCorrective and
Preventative ActionsDeviationsOut of SpecificationsNo or Atypical
YieldsManufacturing and QC RecordsLogbooksAttend internal meetings
as required.Other assigned duties as required.QualificationsHigh
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 is
required.PDN-99152671-d70b-458e-afd3-6d838d97d93b
Keywords: SOFIE, Sterling , Quality Control (QC) / Production Associate I (Chemist) I, Professions , Sterling, Virginia
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