QC Production Associate (Pharma)– Direct Hire!

　　Dallas, TX 75236

　　The QC/Production Associate 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

　　Perform FDG and NaF synthesis according to the client's Standard Operating Procedures (SOPs):

　　Ensure all materials/reagents are accepted according to SOPs and within expiry

　　Ensure all equipment is appropriately qualified prior to use

　　Operate the synthesis unit according to SOPs

　　Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit

　　Perform FDG and NaF quality control (QC) processes according to SOPs:

　　Assist with basic maintenance of QC equipment

　　Ensure all equipment is appropriately calibrated and qualified prior to use o Operate the QC equipment according to SOPs

　　Ensure completion of applicable cGMP documentation.

　　Assist with inventory management:

　　Maintain production/QC/cleaning supply levels as appropriate

　　Assist with inventory reporting

　　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 FDG and NaF production under the advisement of site Cyclotron and Facility Engineer.

　　Maintain a clean and safe working environment.

　　Perform radiation safety duties according to the client's Corporate Radiation Compliance Program and site licensing requirements.

　　Maintain all qualification and validation requirements for entering ISO classified area.

　　Clean classified and non-classified areas according to SOPs.

　　Perform environmental monitoring of classified areas according to SOPs.

　　Report manufacturing metrics into data repository as required.

　　Responsible for opening change controls and initiating, maintaining, and reviewing the client's network and site-specific procedures relative to their job functions.

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

　　Investigations

　　Corrective and Preventative Actions o Deviations

　　Out of Specifications

　　No or Atypical Yields

　　Manufacturing and QC Records

　　Logbooks

　　Attend internal meetings as required.

　　Other assigned duties as required.

　　Qualifications

　　High school diploma required; associate's 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.

　　Up to 5% travel is required

　　Direct Hire with a Full Line of Benefits along with a Competitive Salary!

　　Qualified candidates must be willing to work on the night shift with core hours of 10pm-6:30am with some variation depending on the radiopharmaceuticals being produced.

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.