B. Braun

IT Validation Analyst-CAPS

Job Locations US-CA-Irvine
Requisition ID
2020-17119
Company
Central Admixture Pharmacy Services, Inc.
# of Openings
1
Category
Information Technology
Position Type
Regular Full-Time
Shift
Monday through Friday, 8am - 5pm
Site
CAPS

Overview

CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.

Responsibilities

Position Summary:

 

This individual will design, implement and ensure the technical documentation of the IT systems and software for Good Manufacturing Practices (GMP), Board of Pharmacy and FDA requirements. To ensure that all systems and employees comply with all State and Federal Regulatory Agency requirements. To maintain and audit all related protocols and procedures to meet GMP, BOP & FDA requirements. This position also requires the person to be able to provide technical phone support to CAPS Operations personnel for a variety of IT related issues.

 

 

Responsibilities: Essential Duties

  • Creates computer system validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs, Risk assessments). Implements validation plans and protocols based on system understanding and analysis of functional and system specifications to ensure new and changes to GxP software / computer systems are maintained in a state of control. Ensures compliance with company policies and consistent interpretation and implementation of regulatory controls and industry best practices (e.g., FDA 21 CFR Part 11, new pronouncement, predicate rules, validation and risk-based understanding, ALCOA).
  • Collaborates with business users, IT personnel, Global IT teams and Business Analysts to define validation requirements and plans.
  • Experience with SDLC and related documentation, develops project plans around SDLC for custom software and third party software projects.
  • Maps test cases to user requirements to ensure complete test coverage. Reviews pre-execution and approves GxP relevant test cases for accuracy and effectiveness to test objectives.
  • Review executed acceptance, general system, stress and stability testing for completeness and ensure good documentation practices are followed.
  • Reviews executed test documents and attached evidence to ensure stated criteria is adequately met; provide IT QA approval/ review to test documentation and change controls to proceed with change or implementation activities.
  • Ensures test case failures or exceptions are adequately investigated, logged and resolved.
  • Provides feedback in the review of all deliverables across the IT infrastructure, systems and applications lifecycle, ranging from requirements documentation to design, ensuring compliance with IT standards and company guidelines/policy.
  • Participates in process improvement efforts of computer system policies, procedures and computer system validation processes.
  • Responsible for maintaining, writing and updating procedures and policies regarding the IT change control procedures, system security and standard operating procedures.
  • Represents US locations interests and works with Global Teams to be a subject matter expert on computer system validation guidance and/or audits.
  • Trains business and IT users on Information Technology validation requirements and procedures. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

 

General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

 

Expertise: Knowledge & Skills

  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving complex problems based on experience.
  • Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.

 

 

Preferred Requirements:

 

Experience with programming languages: JavaScript, Java, HTML5 and HL7.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required.
  • 06-08 years related experience required.
  • Regular and predictable attendance
  • Occasional business travel required, Valid driver's license and passport, Ability to work non-standard schedule as needed

 

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

 

 

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

 

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

 

Other

Responsibilities: Other Duties:

 

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

 

Physical Demands:

While performing the duties of this job, the employee is expected to:

  • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

  • Occasionally:Reaching upward and downward, Push/pull, Stand
  • Frequently:Sit, Visual Acuity with or without corrective lenses
  • Constantly:N/A

Activities:

  • Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
  • Frequently:Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
  • Constantly:N/A

Environmental Conditions:

  • Occasionally:N/A
  • Frequently:N/A
  • Constantly:N/A

Work Environment:

 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Noise Intensity:Low
  • Occasionally:Other
  • Frequently:N/A
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

 

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