quality control efforts are performed in accordance with established chemistry, manufacturing, and controls specifications for Ga68 generators and upcoming projects in the pipeline. Responsibilities are as follows: QC Microbiology Qualifications: •Minimum of 10 years of related experience required within c GMP Microbiology laboratory •7 years of related experience with 3 years of experience in leadership position within a microbiology lab of c GMP facility.
•Writing of Microbiological QC SOPs, test methods, protocols and reports, required •Experience with aseptic techniques while performing Sterility, Endotoxin, Particulate Matter and Bioburden testing of drug products, intermediates,
and raw materials per USP and Standard Operating Procedures required •Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, ICH and FDA guidances, etc.
) and the ability to apply them based on the phase of the project (GLP, Phase I, Phase II/III, Commerical etc. ) required •Advanced ability to effectively lead one or more projects with competing priorities to meet the demands of a fast-paced and dynamic work environment •Adaptable to quickly changing priorities •In-depth critical thinking skills to evaluate issues and identify a potential solution •Creatively addresses complex or new problems •Advanced interpersonal skills, including but not limited to problem-solving,
teamwork development, and leadership with other team members •Works well with others to achieve common goals •Ability to foster an inclusive and cooperative work environment •Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands Provide training and work direction to QC Chemists regarding microbiology testing QC Microbiology Responsibilities: •The Microbiologist will play a key role in the execution of microbiological QC methods support radiomedical drug production.
•Leads the execution of microbiological methods for radioactive drug products in a Gx P environment, including Sterility and Bioburden testing of radioactive drug products, intermediates, and raw materials per USP and Standard Operating Procedures (SOP) •Perform Environmental Monitoring for production and monthly testing.
•Review and interpret FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of aseptic radiomedical products •Perform Growth Promotion testing per USP Methods for various microbiological media •Prepare and analyze Biological Indicators in support of Validation and Qualification activities •Perform environmental monitoring (EM) activities •Analyze microbial samples to quantify growth and subculture pure isolates as required •Provide support and assistance with environmental monitoring activities •Assists in supervision of the Microbiology team which includes training, coaching, and relaying performance and development management to supervisor •Provides support and assistance for laboratory personnel in daily activities to fulfill client and GMP requirements •Responsible for training Microbiology Techs on c GMP guidelines 21 CFR 210, 211, 212 (as applicable) and Microbiological test methods •Serves as Subject Matter Expert for Microbiological testing on site •Collaborate with other groups within the facility to understand goals and communicate changes throughout the organization •Writes necessary SOPs, Validation Protocols and Validation Report •General laboratory housekeeping duties and maintenance of the department, premises, and equipment •Manage inventory of laboratory supplies •Collaborate with other team members to ensure the consistent and timely completion of all testing and other tasks in support of business needs •Ensure a safe and quality-minded working environment through conformance with training, general awareness, compliance to safety/Quality guidelines and SOPs, and radiation protection guidelines •Attend mandatory trainings as required by site regulatory requirements and management •Perform other general duties associated with the position as required by supervision •Communicate laboratory budget and laboratory staffing needs to supervisor •Performs other duties as assigned Work Environment: Location: Radio Medix Spica Center, 19705 Aldine Westfield Rd, Humble, TX Work Conditions: The work environment consists of manufacturing, laboratory and office spaces.
The position will sometimes require more than forty hours of work per week.
The position is paid as salary. The work period is typically between 8:30 AM to 5 PM. Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided and radiation monitoring is required and ongoing at the facilities. Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product or others at risk. The position requires physical strength and dexterity with the ability to climb on ladders and up on equipment for environmental service and maintenance responsibilities.
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