Quality Control (QC) / Production Associate I (Chemist)

Title | Quality Control (QC) / Production Associate I (Chemist)
Location | Somerset,NJ
Department | Network Operations
Reports To | Facility Manager

Compensation range | $24 - $28/hr

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 bedependable and responsible in a fast-paced, highly technical environment required.

o   Ability to lift ~50 lbs. required.

o   Up to 5% travel is required.