Change Control Manager Jobs in Indiana (NOW HIRING)

Curium 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.

The Manager Quality Control is responsible for leading the Quality Control team to ensure compliance with all Corporate and local policies, procedures, and regulations. The Manager Quality Control will also schedule laboratory testing and provide resource and instrumentation allocation, conducts laboratory investigations, and implements and monitors corrective actions. This role provides timely testing and notification of any aberrant occurrence to Management that presents potential negative impact to manufactured or marketed product. The Manager will monitor and maintain quality programs that provide assurance that test specifications are met for raw materials, components, finished products, intermediates, stability, and validation testing.

Work Schedule: This position will lead Quality Control during 3rd shift, Saturday - Wednesday, 4 am - 12:30 pm.

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Work cross functionally to coordinate testing schedules and communications in support of the weekly production activities and ensure QC testing and maintenance activities are completed per requirements.
• Perform testing as assigned.
• Schedule and ensure testing of production, raw materials, components, stability, validation, and support of protocol/experimental samples.
• Verify, review, and make appropriate changes if needed, to any controlled document(s)pertinent to area of responsibility.
• Ensure team compliance with all policies, procedures, and site/company regulations.
• Support investigations of process or product failures and customer complaints. Author, and/or review all area quality and safety exceptions and investigation reports.
• Facilitate on time completion of all corrective action items assigned to area.
• Work safely with radioactivity and ensure all direct reports maintain radiological exposure to levels As Low As Reasonably Achievable (ALARA).
• Coach and develop the team to High Performance while fostering a culture of team ownership. Recognize and reward performance.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
• Provide leadership for employees through effective communication, coaching, training and development and provide solutions for the success of the team.
• Conduct daily Huddle board meetings to update employees and track progress.
• Measure and communicate team progress against individual, team and site goals and Key Performance Indicators (KPI’s).
• Manage the department overtime (OT) and ensure that all exception reports are completed and submitted as required.
• Maintain an acceptable level of 5S in the area and promote proper maintenance and cleanliness of the department areas of responsibility.
• Assure compliance with department training and qualification.

• Bachelor Degree in Chemistry, Science or related field required. Work experience is considered in lieu of degree.
• 7 or more years of relevant experience required with previous supervisory experience required.
• Proficiency in cGMP laboratory testing and major laboratory instrumentation.
• Ability to interpret laboratory data and make sound compliance decisions based on such interpretations.
• Excellent communication and interpersonal skills.
• Ability to coach, mentor and teach.
• Excellent decision making, problem solving and analytical skills.
• Change agent with the ability to influence at all levels of the organization.
• Detail-oriented with the ability to work under tight deadlines.
• Ability to handle multiple priorities.
• Builds positive relationships with others.

• 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.

The 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.

Curium 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.