Objective

The Quality Control Analyst I supports and performs routine QC testing on incoming materials, in-process, finished products and stability studies in a time-sensitive radiopharmaceutical environment.  Responsibilities include following established procedures to maintain laboratory quality and efficiencies while ensuring cGMP compliance. 

*** Hours for this position are Midnight to 8am ***

Essential Functions

 

• Performs 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, including basic microorganism identification and documentation.
• Assist with equipment commissioning and qualification activities (IQ/OQ/PQ) under supervision.
• Supports calibration activities and updates the asset management tracker as directed.
• Utilizes electronic systems such as ERP, QMS, EBR, and equipment software with guidance.
• Receives and documents QC materials; maintains QC inventory records.
• Follows procedures to support audit readiness of the laboratory area.
• Prepares chemical reagents for product release testing, maintains lab cleanliness and documents activities in compliance with cGxP requirements.

 

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.
• 0-2 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 preferred but not required.
• Experience handling radioactive materials (gamma, beta and alpha emitters) is a plus.

Knowledge / Skill / Ability
 

• Basic knowledge of analytical techniques and laboratory instrumentation.
• Familiarity with regulatory requirements and guidelines (e.g. FDA, EMA, USP, EP); willingness to learn company-specific procedures.
• Ability to follow instructions, learn new techniques, and contribute to team objectives.
• Ability to work in a team environment with appropriate supervision.
• Good oral and written communication, organization and problem-solving skills.
• Strong interpersonal skills and an interest in learning collaborative lab practices.
• 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.

 

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 able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• 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.
 

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.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.