Curium Pharma
Senior Quality Assurance Specialist
Curium Pharma, Noblesville, Indiana, United States, 46060
Senior Quality Assurance Specialist
Date:
Sep 10, 2024
Location:
Noblesville, IN, United States
About CuriumCurium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.Summary of PositionThe Senior Quality Assurance Specialist position is responsible for product oversight, material release, technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. This position will provide QA oversight to production on the floor, batch release and Quality Events. This position reports to the Senior Manager of Quality.Work Schedule: Monday - Friday 8am-5pm. Ability to work overtime when necessary. Hours are subject to change to meet operation needs.
Essential FunctionsReview and edit documents for accuracy, completeness, and consistency.Perform QA on the Floor function.Gown into a grade C and D environment.Monitor aseptic operations for Quality Assurance.Review batch record completeness for accuracy and compliance.Review and release incoming materials for accuracy and compliance.Manage and prioritize projects in an organized and structured manner. Create, review, and approve Quality policies and procedures.Write, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).Support regulatory and client audits.Conducts internal audits of the QMS and sub systems.Analyze data to identify areas for improvement in the quality system.Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Requirements
Bachelor Degree in Science or related field required.Five or more years of relevant experience in a Pharmaceutical or Medical Device Quality Systems/Quality AssuranceKnowledge of tools, concepts and methodologies of Quality.Auditing experience, along with deviation and lot release support.Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer SystemsWorking knowledge of cGMP guidelines.Proficient in use of Microsoft suite of products.
Working Conditions:Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.May be required to sit or stand for long periods of 8+ hours a day while performing duties.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 corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
DisclaimerThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Equal Opportunity EmployerCurium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment:QA, Quality Assurance, Compliance, Medical Technologist, Forklift, Technology, Quality, Legal, Healthcare, Manufacturing
Date:
Sep 10, 2024
Location:
Noblesville, IN, United States
About CuriumCurium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.Summary of PositionThe Senior Quality Assurance Specialist position is responsible for product oversight, material release, technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. This position will provide QA oversight to production on the floor, batch release and Quality Events. This position reports to the Senior Manager of Quality.Work Schedule: Monday - Friday 8am-5pm. Ability to work overtime when necessary. Hours are subject to change to meet operation needs.
Essential FunctionsReview and edit documents for accuracy, completeness, and consistency.Perform QA on the Floor function.Gown into a grade C and D environment.Monitor aseptic operations for Quality Assurance.Review batch record completeness for accuracy and compliance.Review and release incoming materials for accuracy and compliance.Manage and prioritize projects in an organized and structured manner. Create, review, and approve Quality policies and procedures.Write, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).Support regulatory and client audits.Conducts internal audits of the QMS and sub systems.Analyze data to identify areas for improvement in the quality system.Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Requirements
Bachelor Degree in Science or related field required.Five or more years of relevant experience in a Pharmaceutical or Medical Device Quality Systems/Quality AssuranceKnowledge of tools, concepts and methodologies of Quality.Auditing experience, along with deviation and lot release support.Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer SystemsWorking knowledge of cGMP guidelines.Proficient in use of Microsoft suite of products.
Working Conditions:Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.May be required to sit or stand for long periods of 8+ hours a day while performing duties.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 corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
DisclaimerThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Equal Opportunity EmployerCurium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment:QA, Quality Assurance, Compliance, Medical Technologist, Forklift, Technology, Quality, Legal, Healthcare, Manufacturing