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6 days old

Lead Quality Control Production Associate

Kelly Services
Dallas, TX 75219
**Lead Quality Control (QC) Production Associate-Dallas, TX**


As a Lead QC Production Associate you will serve as a leader in QC and/or Production at the customers sites for the production and/or quality control of drug products. You 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, over all drug products made at the facility. You will also aid the Network Facility Managers in training and mentorship of QC/Production personnel


**Essential Job Functions:**


Travel to various network locations in order to provide:



+ Shift coverage where needed

+ Provide training and mentorship of site QC/Production personnel

+ Examine site trends and identify areas for QC/Production improvement

+ Address other site-specific issues/special projects as assigned

+ Proficient at the manufacturing and quality control of multiple products on multiple platforms according to the companys Standard Operating Procedures (SOPs):

+ Demonstrate understanding of theoretical principles of radiosynthesis and quality control

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

+ Ensure all equipment is appropriately qualified prior to use

+ Operate the platforms according to SOPs

+ Perform routine maintenance and qualification of equipment

+ Perform troubleshooting and emergency maintenance of equipment

+ Ensure completion of applicable cGMP documentation.

+ Perform inventory management:

+ Maintain production/QC/cleaning supply levels as appropriate

+ Perform 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 multiple products production under the advisement of site Cyclotron and Facility Engineer.

+ Maintain a clean and safe working environment.

+ Perform radiation safety duties according to the companys 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.

+ 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 internal meetings as required.

+ Other assigned duties as required.


**Education/Experience Requirement:**


+ High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.

+ 4-years experience in radiopharmaceutical manufacturing and quality control required.

+ Technical experience with computer-controlled automation required.

+ 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.

+ 50-75% travel required.


**Job Details**


+ Job Type: Direct Hire

+ Schedule Type: Full time

+ Hours: 8:00a-5:00p (Mon-Fri)

+ Location: Dallas, TX

+ Salary dependent upon level of education and experience


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-13 Expires: 2022-06-13

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Lead Quality Control Production Associate

Kelly Services
Dallas, TX 75219

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