Quality Control Production Associate
Sofie Co Sofie Co Dallas, TX Dallas, TX Full-time Full-time $24 - $32 an hour $24 - $32 an hour 2 days ago 2 days ago 2 days ago Overview 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.
Essential Duties and Responsibilities o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):
o Ensure all materials/reagents are accepted according to SOPs and within expiry o Ensure all equipment is appropriately qualified prior to use o Operate the synthesis unit according to SOPs o Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit o Perform FDG and NaF quality control (QC) processes according to SOPs:
o Assist with basic maintenance of QC equipment o Ensure all equipment is appropriately calibrated and qualified prior to use o Operate the QC equipment according to SOPs o Ensure completion of applicable cGMP documentation.
o Assist with inventory management:
o Maintain production/QC/cleaning supply levels as appropriate o Assist with inventory reporting o Perform material acceptance according to SOPs o Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
o Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility Engineer.
o Maintain a clean and safe working environment.
o Perform radiation safety duties according to SOFIE's Corporate Radiation Compliance Program and site licensing requirements.
o Maintain all qualification and validation requirements for entering ISO classified area.
o Clean classified and non-classified areas according to SOPs.
o Perform environmental monitoring of classified areas according to SOPs.
o Report manufacturing metrics into data repository as required.
o Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
o Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:
o Investigations o Corrective and Preventative Actions o Deviations o Out of Specifications o No or Atypical Yields o Manufacturing and QC Records o Logbooks o Attend internal meetings as required.
o Other assigned duties as required.
Qualifications o High school diploma required; associate's degree in chemistry, engineering, or natural sciences preferred.
o Technical experience with computer-controlled automation preferred.
o Efficient in the use of MS Office Suite required.
o Ability to work various shifts and weekends required.
o Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.
o 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.
o Ability to lift 50 lbs.
required.
o Up to 5% travel is required.
Job Type:
Full-time Pay:
$24.
00 - $32.
00 per hour Expected hours:
40 per week
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Parental leave Tuition reimbursement Vision insurance Schedule:
Day shift Night shift Weekends as needed Work setting:
In-person Application Question(s):
Are you comfortable with the core hours being from 2100-0500 and 0000-0800.
Experience:
Manufacturing:
1 year (Preferred) Shift availability:
Night Shift (Required) Overnight Shift (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
Essential Duties and Responsibilities o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):
o Ensure all materials/reagents are accepted according to SOPs and within expiry o Ensure all equipment is appropriately qualified prior to use o Operate the synthesis unit according to SOPs o Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit o Perform FDG and NaF quality control (QC) processes according to SOPs:
o Assist with basic maintenance of QC equipment o Ensure all equipment is appropriately calibrated and qualified prior to use o Operate the QC equipment according to SOPs o Ensure completion of applicable cGMP documentation.
o Assist with inventory management:
o Maintain production/QC/cleaning supply levels as appropriate o Assist with inventory reporting o Perform material acceptance according to SOPs o Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
o Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility Engineer.
o Maintain a clean and safe working environment.
o Perform radiation safety duties according to SOFIE's Corporate Radiation Compliance Program and site licensing requirements.
o Maintain all qualification and validation requirements for entering ISO classified area.
o Clean classified and non-classified areas according to SOPs.
o Perform environmental monitoring of classified areas according to SOPs.
o Report manufacturing metrics into data repository as required.
o Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
o Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:
o Investigations o Corrective and Preventative Actions o Deviations o Out of Specifications o No or Atypical Yields o Manufacturing and QC Records o Logbooks o Attend internal meetings as required.
o Other assigned duties as required.
Qualifications o High school diploma required; associate's degree in chemistry, engineering, or natural sciences preferred.
o Technical experience with computer-controlled automation preferred.
o Efficient in the use of MS Office Suite required.
o Ability to work various shifts and weekends required.
o Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.
o 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.
o Ability to lift 50 lbs.
required.
o Up to 5% travel is required.
Job Type:
Full-time Pay:
$24.
00 - $32.
00 per hour Expected hours:
40 per week
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Parental leave Tuition reimbursement Vision insurance Schedule:
Day shift Night shift Weekends as needed Work setting:
In-person Application Question(s):
Are you comfortable with the core hours being from 2100-0500 and 0000-0800.
Experience:
Manufacturing:
1 year (Preferred) Shift availability:
Night Shift (Required) Overnight Shift (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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