(Contractor) Data Integrity Specialist

(Contractor) Data Integrity Specialist

The Data Integrity Specialist will support electronic and paper-based systems at our Maryland Heights facility.

Essential Functions:

• Research Laboratory and Manufacturing processes to develop compliance gap assessments related to data integrity.
• Understand Laboratory and Manufacturing data life cycles to develop data maps.
• Report on progress of data integrity work and significance of the results.
• Complete Periodic System Reviews according to schedule, working with system administrators and subject matter experts to accurately assess the systems and the associated data.
• Assess risks related to data integrity and collaborate with colleagues to mitigate and implement appropriate corrective actions.
• Assist Laboratory and Manufacturing personnel with development of procedures, job aids and other documentation to improve the overall site compliance stance.
• Perform data integrity training using approved course curriculum.
• Utilize expertise and information on data integrity to assist Laboratory and Manufacturing personnel on compliance issues.
• Maintain current knowledge of federal and international data integrity regulations.
• Work independently and manage workload.
• Manage and prioritize project in an organized and structured manner.
• Maintain the required percentage complete on all assigned site training.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Author standard operating procedures.
• Create data maps for laboratory and manufacturing systems.
• Assist site staff in adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.
• 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.).
• All other responsibilities as assigned with or without accommodation.

Requirements:

• Bachelor Degree preferred. Work experience is considered in lieu of degree.
• Three or more years of relevant work experience required.
• Candidates must understand how to apply regulations within manufacturing and laboratory environments.
• Experience reviewing / authoring standard operation procedures.

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.

Equal Opportunity Employer:

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.