QC/Production Associate I

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.