Lead Quality Control Microbiology Technician

Summary of Position

Perform assigned quality control activities in order to comply with applicable SOP's and cGMPs. Coordinate the work of others for the Microbiology team. Work under limited supervision with latitude for the use of initiative and independent judgment.  Ability to manage projects with cross functional teams.

Schedule:
Monday through Friday 8:00 am - 4:30 pm
Sunday rotational shift
Occasional off shift, weekend, and holiday work required

Essential Functions

• Employ aseptic techniques while performing Sterility, Endotoxin, Particulate Matter and Bioburden testing of radioactive drug products, intermediates, and raw materials per USP and Curium Standard Operating Procedures (SOP) and Standard Test Methods (STM)
• Perform in vivo biological performance testing of final product in support of product efficacy and quality per USP and Curium Standard Test Methods (STM)
• Perform Growth Promotion testing per USP Methods for various microbiological media 
• Prepare and analyze Biological Indicators in support of Validation and Qualification activities 
• Analyze microbial samples to quantify growth and subculture pure isolates as required
• Data entry and review in Laboratory Management Systems (LIMS)
• 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. Includes scheduling technicians daily routine activities.
• Assist in the training and development of department technicians
• Assist with laboratory investigations, root cause analysis, and implementation of corrective and preventative actions 
• 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

Requirements

• Bachelor’s degree preferred in life science or a related field
• 6 or more years of relevant experience in a cGMP / FDA regulated facility 
• Willingness to perform in vivo testing in support of product efficacy and quality
• Good interpersonal skills, good hands on, analytical, problem solving and decision-making skills 
• Excellent writing and verbal communications skills
• Close attention to detail required
• Good computer skills, including utilizing personal computers and data entry programs
• Ability to work independently and with others to accomplish goals and priorities
• Flexibility and teamwork skills 
• High level of energy and regular, consistent attendance

Working Conditions:

• Standard office environment coupled with approximately 80% time in radiopharmaceutical manufacturing and laboratory environments 
• Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
• Must be willing to wear a variety of personal protective equipment
• Willingness to work in a team-based environment
• May be required to sit or stand for long periods of time while performing duties
• Must be able to work outside of regular work hours
• Responsibilities also include the ability to lift up to 70 pounds, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation
• Must possess good hand-eye coordination