QC Production Associate Sofie Co - 2.5 Romeoville, IL Job Details Full-time $26 - $28 an hour 5 hours ago Benefits Health savings account Relocation assistance Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Computer operation Customer communication High-performance liquid chromatographs High school diploma or GED Attention to detail Chemistry Productivity software Associate's degree

Full Job Description Description:

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:

$26.00 - $28.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Relocation assistance Retirement plan Vision insurance

Experience:

TLC:

1 year (Preferred)

GC:

1 year (Preferred)

HPLC:

1 year (Required)

License/Certification:

RPH License (Preferred) Shift availability: Overnight Shift (Required) Ability to

Commute:

Romeoville, IL 60446 (Required)

Work Location:

In person