Quality Systems Analyst

The Quality Systems Analyst position is responsible for the administration, development, and support of the Quality Computer Systems in compliance with applicable regulations. This position reports to the Director, Quality Systems. The Quality System Analysts have a responsibility to support all areas of the region for overall compliance and adherence in regards to the site Quality Computer Systems.

Schedule: Monday - Friday 8:00 am - 5:00 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.).
• Provide application technical support, including investigation/ troubleshooting and timely resolution of system issues.
• Develop system workflows and implement enhancements to existing applications.
• Define system requirements, priorities, and viable alternatives.
• Support interfaces with external applications.
• Work with vendors to establish and maintain quality software systems.
• Support the delivery of quality software through effective design and configuration.
• Responsible for the full system life cycle from design, configuration, testing, validation, implementation to maintenance and application support.
• Support projects assigned to systems analysts.
• Assist in developing user documentation and regional policies and procedures that impact the use of application systems.

• Bachelor Degree in Science or related field required.
• 3 or more years of relevant experience required.
• Must have working knowledge in Quality System Management applications. LIMS system knowledge preferred
• Must have working knowledge of Quality System Software Development Life Cycle (SDLC) management, including data and configuration change management, data integrity, system security, and disaster recovery.
• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer Systems.
• Working knowledge of cGMP guidelines.
• Proficient in use of Microsoft suite of products.
• Must have ability to exercise independent judgment in planning, organizing, and performing systems analyst tasks. Some independent judgment required in setting priorities of tasks among multiple assigned projects.
• Must have ability to communicate with a broad spectrum of personnel throughout the network, frequently under deadline pressure.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must possess strong problem solving, decision making, verbal and written communications skills.
• Results-oriented, able to make decisions and prioritize work per business needs in a fast paced environment.
• Good analytical and problem-solving skills.
• Strong communication, organization and time management skills.
• An understanding of the pharmaceutical industry and its unique business and social responsibilities.
• A thorough understanding of the requirements outlined in FDA 21 CFR Part 11.

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.