Quality Control Analyst III

Objective

The Quality Control Analyst III is responsible for overseeing and performing QC testing on incoming materials, in-process, finished products, and stability studies within a time-sensitive radiopharmaceutical environment. This role includes driving laboratory quality initiatives, supporting efficiency improvements, ensuring cGMP compliance, and acting as a subject matter expert and mentor to other analysts. The Quality Control Analyst III will also play a key role in project initiatives and support regulatory readiness.

Essential Functions

• Provide technical oversight and perform QC testing on incoming materials, finished products, and stability studies, ensuring compliance with SOPs and cGMP guidelines, including:

• Advanced chemistry testing, instrumental and wet chemistry analyses.

• Environmental Monitoring and utilities testing, with analysis and interpretation of results.

• Sterility, microbial limits, Endotoxin testing, and trending of microorganisms.

• Lead efforts in equipment commissioning and qualification (IQ/OQ/PQ), providing technical expertise and guidance to ensure validation protocols are followed.

• Manage the calibration and maintenance schedules of critical assets and maintain the asset management system, ensuring regulatory compliance.

• Act as the QC lead for ERP, QMS, EBR, and equipment software implementation and usage, ensuring that QC processes are streamlined and in line with industry best practices.

• Oversee the QC material acceptance process and inventory management, working closely with supply chain teams to ensure uninterrupted operations.

• Support continuous improvement initiatives and ensure the QC laboratory remains audit-ready, participating in internal and external audits as a key representative.

• Mentor junior staff on technical QC processes and ensure adherence to quality standards, providing training and support for troubleshooting technical issues.

• Prepare complex chemical reagents for product release testing, ensuring lab cleanliness and adherence to cGxP practices at all times.

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

• BA/BS degree in Chemistry, Biochemistry, Biological Sciences, or related field; Master's degree preferred.
• Minimum of 5+ years of experience in a QC laboratory, preferably in pharmaceutical or radiopharmaceutical environments.
• Strong knowledge of GMP-compliant manufacturing, with hands-on experience following ALCOA+ principles and 21 CFR 211 guidelines.
• Experience in handling radioactive materials, including gamma, beta, and alpha emitters.
• Demonstrated leadership or supervisory experience in a laboratory setting.

Knowledge / Skill / Ability

• Expertise in analytical techniques and laboratory instrumentation, with the ability to troubleshoot and optimize processes.
• Advanced knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, USP, EP) with experience in regulatory audits.
• Strong planning, organization, and project management skills, with an ability to lead team initiatives.
• Excellent problem-solving, communication, and interpersonal skills, with the ability to influence and mentor cross-functional teams.
• Ability to lift/move materials and handle hazardous materials as required by the role.
• Flexibility in scheduling to support night shifts, overtime, weekends, and holidays as necessary.

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.