Quality Control Microbiologist

ObjectiveWorking under minimal supervision, the Quality Control Microbiologist is responsible for helping ensure the microbiological quality of Perspective Therapeutics’ products and processes, through continually advancing aseptic awareness, contamination control strategy and site practices while adhering to all applicable regulations and standards. The Microbiologist will act as the Quality Control representative on initiatives, projects, and committees relating to sterility assurance.Essential FunctionsWorks with management, functional partners and subject matter experts to establish and evolve a contamination control strategy for aseptic manufacture and supply of clinical trial radiopharmaceutical drug products. Oversees aseptic and microbiological training of site staffConducts microbiological testing of raw materials, in-process samples, finished products, and environmental monitoring samplesPerforms sterility testing, endotoxin testing, microbial limits testing, and other relevant assays in accordance with SOPs and cGMP guidelines. Performs verification and approval of data to ensure accuracy. Evaluates data/lab trends and advises management on needed improvementsLeads, writes, and executes protocols/reports for new or changes to processes or procedures as well as investigations related to sterility assurance. Qualifies instruments, validates QC laboratory methods, evaluates new materials/products, and establish testing standards. Performs periodic QVAs (quality validation assessments). Responsible for calibration and maintenance of equipment, lab supplies inventory, and related vendor coordination, POs/budgetingAssists with inspection readiness and acts as department SME during audits/regulatory inspections, author responsesUtilizes a range of electronic systems such as document/equipment management software, QMS, LIMS, and ERP (if applicable). May be the administrator for laboratory software systems and on notifications for responding to alarmsAuthors, reviews and acts as document owner for procedure changes; take QC lead on change controls, CAPAs, and other quality system requirementsRepresents Quality Control in team meetings and projects (inter & cross-functional), providing technical perspective and expertise, including on regulatory filings if applicable. Works on special projects as needed. Identify and lead some continuous improvement effortsParticipates in tech transfers. Trains personnel to develop and improve skill setsMaintains and enhances personal technical, regulatory and compendial expertise. Actively promotes safety rules and awareness. Contributes to the completion of milestones associated with specific projects. QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education / ExperienceRequires a BA/BS degree in Microbiology, Biochemistry, Biological Sciences, or a related field; Master’s degree preferred. Minimum of 5 years of experience in a microbiology laboratory, within the pharmaceutical or radiopharmaceutical industryFamiliarity with regulatory requirements and guidelines (e.g., FDA, EMA, USP, EP)Experience performing bioburden and sterility tests, and environmental monitoring using EM Total Particulate/Viable monitors, and other required equipment/materials. Experience in a GMP compliant manufacturing following ALCOA+ principle and 21 CFR 211 guidelines is highly preferredRadioactive material handling of gamma, beta and alpha emitters experience preferredKnowledge / Skill / AbilityIn-depth knowledge of microbiological techniques and aseptic processingExpertise in analytical techniques required (HPLC, GC, gamma spectroscopy, iTLC, Endotoxin, etc.)Ability to plan, implement and execute activities to achieve personal and team performance objectivesAbility to work in a team environment with minimum supervision required. Excellent oral and written communication, organization and problem-solving skillsStrong interpersonal skills and an understanding of group dynamicsMust be able to lift / move materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals / waste containersFlexibility with scheduling requirements may include night shift, overtime, weekends and holiday coverageWork EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Must be willing to work in a facility producing radioactive materials. Note - employees are required to participate in safety programs designed to minimize potential and/or actual exposure levelsMust be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as neededMay be required to sit or stand for long periods of 8+ hours a day while performing dutiesOccasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be requiredMust possess good hand-eye coordination; close attention to detail is requiredWillingness to complete safety training within allotted timeframes, and work in a team-based environmentPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.Powered by JazzHROF7aRLpPk3