Quality Control Analyst

Objective The Quality Control Analyst performs QC testing on incoming materials, in-process, finished products and stability studies in a time-sensitive radiopharmaceutical environment.  Responsibilities include supporting laboratory quality, efficiencies, and improvements, and ensuring cGMP compliance.  S / he will act as Quality Control representative on initiatives, projects, and committees.    Essential Functions Prepares all chemical reagents for product release testing and ensures lab cleanliness and maintain records with consistent cGxP practice. Provides oversight related to testing incoming materials, in-process and finished products, stability studies and project support. Performs all QC testing of incoming materials, finished products and stability studies in accordance with SOPs and cGMP guidelines, including : Chemistry testing, including instrumental and wet chemistry analyses. Routine Environmental Monitoring and utilities testing. Sterility, microbial limits and Endotoxin testing, identify and trend microorganisms. Provide technical support during equipment commissioning and qualification (IQ / OQ / PQ). Coordinate calibration schedules of assets and update the asset management tracker. Ensure proper acceptance of QC materials, maintain and update current QC inventory. Provides support to ensure audit readiness of laboratory area. Utilize and ensure appropriate staff use of a wide range of electronic systems such as ERP, QMS, EBR, and equipment software. Update and maintain Standard Operating Procedures (SOPs, test records and protocols). Actively promotes safety rules and awareness. Collaborate directly with other departments to achieve completion of projects (Manufacturing, QA, Engineering, RSO, EH&S etc). Qualifications To 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 / Experience Requires a BA / BS degree in Chemistry, Biochemistry, Biological Sciences, or a related field; Master's degree preferred. Minimum of 3 years of experience in a quality control laboratory, preferably within the pharmaceutical or radiopharmaceutical industry. Experience in a GMP compliant manufacturing following ALCOA+ principle and 21 CFR 211 guidelines is highly preferred. Radioactive material handling of gamma, beta and alpha emitters experience preferred. Knowledge / Skill / Ability In-depth knowledge of analytical techniques and laboratory instrumentation. Familiarity with regulatory requirements and guidelines (e.g. FDA, EMA, USP, EP). Ability to plan, implement & execute activities to achieve personal and team performance objectives. Ability to work in a team environment with minimum supervision required. Excellent oral and written communication, organization and problem-solving skills Strong interpersonal skills and an understanding of group dynamics. Must be able to lift / move materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals / waste containers. Flexibility with scheduling requirements may include night shift, overtime, weekends and holiday coverage. This is a night shift position (12am - 8am) with some weekend, overtime and holiday work . Work Environment The 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 levels. Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties.  Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required. Must possess good hand-eye coordination; close attention to detail is required. Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Please 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 JazzHR