QC Production Associate

2 weeks ago

Sterling, United States SOFIE Full time

Job Description | QC/Production Associate (Floater)



Title | QC/Production Associate (Floater)

Location | Open to any SOFIE Locations

Department | Network Operations

Reports To | Product Support Manager, RCM



Overview

The QC/Production Associate(floater) will operate and maintain the radiosynthesizers for the production of drug product, as well as operate and maintain analytical equipment for the quality control of drug product. They will aid the Network Facility/Production Managers in training and mentorship of QC/Production personnel.



Essential Duties and Responsibilities

· Travel to various network locations in order to provide:

o Shift coverage where needed. o Provide training and mentorship onsite QC/Production personnel. o Examine and identify areas for QC/Production improvement. o Other network assigned special projects. · Proficient at the manufacturing and quality control of multiple products on multiple platforms according to SOFIE Standard Operating Procedures (SOPs)

o Demonstrate understanding of theoretical principles of radiosynthesis and quality control. o Ensure all materials/reagents are prepared/accepted according to SOPs and within expiry. o Ensure all equipment is appropriately qualified prior to use. o Operate the platforms according to SOPs. o Perform routine maintenance and qualification of equipment. o Perform troubleshooting and emergency maintenance of equipment. · Ensure completion of applicable cGMP documentation.

· Assist with inventory management:

· Maintain production/QC/cleaning supply levels as appropriate

· Perform material acceptance according to SOPs

· Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.

· Perform basic computer-controlled cyclotron operations for multiple drug products’ 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 non-classified areas according to SOPs.

· Report manufacturing metrics into data repository as required.

· Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:

· Investigations

· Corrective and Preventative Actions

· Deviations

· Out of Specifications

· No or Atypical Yields

· Manufacturing and QC Records

· Logbooks

· Attend network meetings as required.

· Other assigned duties as required.





Qualifications

· High school diploma required; Associate 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.

· 40-60% travel (based on network needs)




The description provided above is not intended to be an exhaustive list of all job duties, responsibilities, and requirements. Duties, responsibilities, and requirements may change over time and according to business need.

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