Perspective Therapeutics, Inc
Quality Control Analytical and Microbiology Supervisor
Perspective Therapeutics, Inc, Trenton, New Jersey, United States,
Quality Control Analytical and Microbiology Supervisor
Perspective Therapeutics is seeking a highly motivated Quality Control Supervisor with expertise in analytical chemistry and microbiology to join our dynamic team. The ideal candidate will oversee the quality control and microbiology processes, ensuring that all products meet stringent safety and efficacy standards. You will play a critical role in developing and implementing QC protocols, conducting analytical and microbiological testing, and maintaining compliance with regulatory requirements.Essential Functions
Supervise the QC analytical and microbiology laboratory product testing schedule and personnel task assignment, providing guidance and training on chemical testing methods.Develop, validate, and implement quality control procedures, methods, and protocols to ensure product quality.Conduct routine QC analytical and microbiological testing on raw materials, in-process samples, and finished products.Monitor and review testing data, identifying trends and recommending corrective actions as necessary.Ensure compliance with industry regulations and quality standards (e.g., FDA, ISO) through regular audits and inspections.Collaborate with R&D and production teams to support product development and resolve quality issues.Maintain accurate documentation of all QC analytical and microbiological activities, including test results, deviations, and corrective actions.Assist in the preparation of regulatory submissions and inspections.Stay current with industry trends, techniques, and regulations to continuously improve QC practices.Establish and maintain site contamination control plans and media fill simulation activities.Author, review, and act as document owner for procedure changes; take QC lead on change controls, CAPAs, and other quality system requirements.Represent Quality Control in team meetings and projects, providing technical perspective and expertise, including on regulatory filings if applicable. Work on special projects as needed. Identify and lead some continuous improvement efforts.Participate in tech transfers. Train personnel to develop and improve skill sets.Maintain and enhance personal technical, regulatory, and compendial expertise.Actively promote safety rules and awareness.Contribute to the completion of milestones associated with specific projects.Qualifications
Strong knowledge of chemical analysis and microbiological techniques and test methods.Experience with laboratory equipment and software used in quality control testing.Familiarity with regulatory standards (e.g., GMP, GLP) and quality management systems.Excellent problem-solving skills and attention to detail.Strong leadership and communication skills, with the ability to work collaboratively in a team environment.Familiarity 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 environment following ALCOA+ principles and 21 CFR 211 guidelines is highly preferred.Radioactive material handling experience with gamma, beta, and alpha emitters preferred.Education / Experience
Bachelor’s degree in Chemistry, Biochemistry, or a related field; Master’s degree preferred.Minimum of 7 years of experience in a quality control role within the biotech, pharmaceutical, or related industry.3+ years of experience leading teams in a Quality Control capacity preferred.Knowledge / Skill / Ability
In-depth knowledge of microbiological techniques and aseptic processing.Expertise in analytical techniques required (HPLC, GC, gamma spectroscopy, iTLC, Endotoxin, etc.).Ability to plan, implement, and 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.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 and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.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.Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
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Perspective Therapeutics is seeking a highly motivated Quality Control Supervisor with expertise in analytical chemistry and microbiology to join our dynamic team. The ideal candidate will oversee the quality control and microbiology processes, ensuring that all products meet stringent safety and efficacy standards. You will play a critical role in developing and implementing QC protocols, conducting analytical and microbiological testing, and maintaining compliance with regulatory requirements.Essential Functions
Supervise the QC analytical and microbiology laboratory product testing schedule and personnel task assignment, providing guidance and training on chemical testing methods.Develop, validate, and implement quality control procedures, methods, and protocols to ensure product quality.Conduct routine QC analytical and microbiological testing on raw materials, in-process samples, and finished products.Monitor and review testing data, identifying trends and recommending corrective actions as necessary.Ensure compliance with industry regulations and quality standards (e.g., FDA, ISO) through regular audits and inspections.Collaborate with R&D and production teams to support product development and resolve quality issues.Maintain accurate documentation of all QC analytical and microbiological activities, including test results, deviations, and corrective actions.Assist in the preparation of regulatory submissions and inspections.Stay current with industry trends, techniques, and regulations to continuously improve QC practices.Establish and maintain site contamination control plans and media fill simulation activities.Author, review, and act as document owner for procedure changes; take QC lead on change controls, CAPAs, and other quality system requirements.Represent Quality Control in team meetings and projects, providing technical perspective and expertise, including on regulatory filings if applicable. Work on special projects as needed. Identify and lead some continuous improvement efforts.Participate in tech transfers. Train personnel to develop and improve skill sets.Maintain and enhance personal technical, regulatory, and compendial expertise.Actively promote safety rules and awareness.Contribute to the completion of milestones associated with specific projects.Qualifications
Strong knowledge of chemical analysis and microbiological techniques and test methods.Experience with laboratory equipment and software used in quality control testing.Familiarity with regulatory standards (e.g., GMP, GLP) and quality management systems.Excellent problem-solving skills and attention to detail.Strong leadership and communication skills, with the ability to work collaboratively in a team environment.Familiarity 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 environment following ALCOA+ principles and 21 CFR 211 guidelines is highly preferred.Radioactive material handling experience with gamma, beta, and alpha emitters preferred.Education / Experience
Bachelor’s degree in Chemistry, Biochemistry, or a related field; Master’s degree preferred.Minimum of 7 years of experience in a quality control role within the biotech, pharmaceutical, or related industry.3+ years of experience leading teams in a Quality Control capacity preferred.Knowledge / Skill / Ability
In-depth knowledge of microbiological techniques and aseptic processing.Expertise in analytical techniques required (HPLC, GC, gamma spectroscopy, iTLC, Endotoxin, etc.).Ability to plan, implement, and 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.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 and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.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.Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
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