CMS Certification Analyst: Documentation & Strategy

TechDigital Group; United States; On-site; USD 90,000 - 110,000; Full time

Job summary

An established industry player is seeking a Certified Business Analyst with expertise in CMS to oversee the certification process for the Data Ecosystem. This role involves developing strategies for documentation, ensuring compliance with CMS requirements, and leading certification reviews. If you are passionate about certification processes and have a keen eye for detail, this opportunity allows you to make a significant impact in a dynamic environment. Join a team that values innovation and excellence in the certification realm.

Qualifications

• Experience with CMS for certification efforts in Data Ecosystem.
• Strong documentation skills for system artifacts.

Responsibilities

• Ensure DE Component functionality meets CMS Certification requirements.
• Lead Client participation in certification reviews.

Skills

CMS experience

Certification strategy development

Documentation skills

Education

Certified Business Analyst (CBA)

Job description

Experience in a regulated environment o Can effectively work in a team setting and communicate effectively across the department o Strong attention to detail o Ability to be punctual in order to ensure production o Ability to work on assignments that are semi-routine in nature with the skill to recognize any deviations from specification o Ability to operate independently within the constraints of approved process-related documentation Proficient/Working Skills: o Must be proficient in English with the ability to read, write, analyze/evaluate charts, follow simple diagrams and perform basic arithmetic o Basic proficiency with PCs (Personal Computers) and basic use of a Windows environment is required

Performs routine set up, operation, minor routine maintenance, preventative maintenance (PM) and troubleshooting of moderately complex/automated manufacturing equipment. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective product, packaging, and component material. Assists with root-cause analysis activities for process or product exceptions. Checks work using prescribed gauges, jigs and fixtures to measure close tolerances. May monitor quality in accordance with statistical process or other control procedures. Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality.

Responsibilities and Duties

o Works within standards and operating procedures to plan, perform, and make decisions regarding the set up and operations of a variety of production equipment, including automated machine processes and controls to perform routine assembly-line production functions of filling, packing, assembling, labeling and inspecting

o Uses independent judgment in troubleshooting and problem solving under general supervision

o May perform clean up functions in sterilized areas

o Identifies the need for minor equipment repairs

o May analyze and evaluate charts, follows simple diagrams, testing, and inspecting procedures

o Assists with root-cause analysis activities for process or product exceptions

o May monitor quality in accordance with statistical process or other control procedures.

o Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality.

o Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)

o Must follow all Client housekeeping policies and procedures

o Must follow all Client safety policies and procedures

o Must be able to work overtime as required to meet Client business requirements

Must be able to work flexible and/or extended hours and report to work on a regular, punctual basis. Ability to get along with people and be able to work in a team environment. Willingness to rotate into different tasks and responsibilities.