CSV Compliance Specialist

4 weeks ago


Decatur, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Qualifying/ re-qualifying cloud-based environment IaaS, SaaS, PaaS
  • Review validation deliverables in project initiation phase - User Requirement Specifications (URS) and GxP Assessment, Functional Specifications, Design Specifications, Configuration Specifications, Technical Specifications, etc.
  • Preparing or reviewing validation deliverables in testing phase Protocols and Test Scripts for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Requirement Traceability Matrix (RTM) report, 21 CFR Part 11 Assessment, Summary reports.
  • Computer Systems Validation 7+ years
  • Proficient in Technical Writing, MS Office and Adobe documentation software
  • Author, Execution, & Review of CSV SOP's, Templates, Change Controls, Deviation tasks, CAPA tasks
  • Knowledge of Compliance Guidance's related to CSV.


  • Decatur, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Qualifying/ re-qualifying cloud-based environment IaaS, SaaS, PaaS Review validation deliverables in project initiation phase - User Requirement Specifications (URS) and GxP Assessment, Functional Specifications, Design Specifications, Configuration Specifications, Technical Specifications, etc. Preparing or reviewing validation...


  • Decatur, United States Provision People Full time

    Job DescriptionJob DescriptionRelocation assistance is provided to the qualified candidate!Summary:Our award-winning client is seeking a Safety Systems Specialist to join their team. Join our team as a Safety Systems Specialist and play a pivotal role in building and maintaining a best-in-class Safety and Health Management System (SHMS) based on ISO...


  • Decatur, United States Provision People Full time

    Relocation assistance is provided to the qualified candidate!Summary:Our award-winning client is seeking a Safety Systems Specialist to join their team. Join our team as a Safety Systems Specialist and play a pivotal role in building and maintaining a best-in-class Safety and Health Management System (SHMS) based on ISO 45001.Responsibilities:Spearheaded the...


  • Decatur, United States Alcanza Clinical Research Full time

    Clinical Research Regulatory Specialist Department: Quality, Regulatory & Source Employment Type: Full Time Location: Accel Research Sites - Decatur, GA Reporting To: Melissa Hodges Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We...


  • Decatur, United States Stealth Recruiting Services Full time

    Job DescriptionJob Description85k to 100kJob DescriptionSummary/ Objective:The Safety Systems Specialist performs duties at the professional level in some or all of the following functional areas:Lead the organization’s Safety & Health Management System (SHMS),(e.g., ISO 45001).Work alongside and support team members in the safety department.Establish,...


  • Decatur, United States Alcanza Clinical Research Full time

    Clinical Research Regulatory Specialist (Must live in Atlanta/Decatur area)Department: Quality, Regulatory & SourceEmployment Type: Full TimeLocation: Accel Research Sites - Decatur, GAReporting To: Angeline NewcombDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL,...


  • Decatur, United States Alcanza Clinical Research Full time

    Clinical Research Regulatory Specialist (Must live in Atlanta/Decatur area) Department: Quality, Regulatory & Source Employment Type: Full Time Location: Accel Research Sites - Decatur, GA Reporting To: Angeline Newcomb Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC,...


  • Decatur, United States Alcanza Clinical Research Full time

    Job DescriptionJob DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general...


  • Decatur, United States YMCA Metro Atlanta Full time

    As a thought-leader and best-in-class provider in education, wellness, youth development, and community-building, The YMCA of Metro Atlanta is one of the oldest and most essential non-profits serving in Atlanta. Today, we're looking for you to join us as we carry out our mission to positively impact lives and communities across the state. At the Y, we're an...


  • Decatur, Illinois, United States ADM Full time

    Job Description Process Specialist, Cash Application - Global Business Services - Decatur, ILThis is a full-time non-exempt level position.GeneralThe NA Global Business Services Center has an opening for a full-time Process Specialist, Cash Application in the Decatur office. The position has high engagement in a wide variety of functions focused on providing...


  • Decatur, United States YMCA Of Metro Atlanta Full time

    As a thought-leader and best-in-class provider in education, wellness, youth development, and community-building, The YMCA of Metro Atlanta is one of the oldest and most essential non-profits serving in Atlanta. Today, we're looking for you to join us as we carry out our mission to positively impact lives and communities across the state. At the Y, we're an...


  • Decatur, United States ADM Full time

    Job Description Process Specialist, Cash Application - Global Business Services - Decatur, ILThis is a full-time non-exempt level position.GeneralThe NA Global Business Services Center has an opening for a full-time Process Specialist, Cash Application in the Decatur office. The position has high engagement in a wide variety of functions focused on...

  • Sales Specialist

    1 day ago


    Decatur, United States Cook's Pest Control, Inc. Full time

    Job DescriptionJob DescriptionCompany DescriptionCook’s Pest Control, Inc., a family-owned business, has over 300,000 customers, 1650+ employees and 37 locations. Cook’s has been servicing customer for over 90 years and is known throughout the Southeast for their integrity, community involvement, and commitment to excellence. With that kind of...


  • Decatur, United States Alcanza Clinical Research Full time

    Job DescriptionJob DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general...


  • Decatur, United States Positive Impact Health Centers INC Full time

    Job DescriptionJob DescriptionDescription:Are you seeking a career with a growing company, a place where you can make an impact in the community? Then Positive Impact Health Centers is the company for you. Positive Impact Health Centers (PIHC) is a community leader in providing HIV prevention, care and treatment services located in Metro Atlanta. The PIHC...


  • Decatur, United States BANK INDEPENDENT Full time

    Job DescriptionJob DescriptionGeneral SummaryUnder the supervision of the Customer Service Manager or Supervisor, and in compliance with established policies and procedures, the Customer Service Specialist I performs functions for the Customer Service Department. Functions may include such tasks as customer service duties, collection efforts, data entry,...


  • Decatur, United States Emory Healthcare Full time

    Description: JOB DESCRIPTION: Coordinates care of sepsis patients from ED triage to discharge in 1-2 Emory Healthcare Hospitals. Provides knowledge and skill in the care of Sepsis patients as a resource to staff, the interdisciplinary team and community caring for the patient within their specific area. Maintains QA data with the goals of achieving clinical...


  • Decatur, United States DeKalb County Full time

    Job DescriptionPositions available in multiple departments - APPLY TODAY!Job Code: 99015 Salary Range: $17.19 - $26.64/hour depending on experience FLSA: NonexemptEssential Functions: The following duties are normal for this position. The omission of specific statements of the duties does not exclude them from the classification if the work is similar,...


  • Decatur, United States DeKalb County Full time

    Positions available in multiple departments - APPLY TODAY! Job Code: 99015 Salary Range: $17.19 - $26.64/hour depending on experience FLSA: Nonexempt Essential Functions: The following duties are normal for this position. The omission of specific statements of the duties does not exclude them from the classification if the work is similar,...


  • Decatur, United States Utility Associates, Inc. Full time

    Job DescriptionJob DescriptionThe corporate recruiter will develop and execute recruiting and staffing strategies by identifying, recruiting, screening, and qualifying candidates who meet the requirements, knowledge, skills, abilities, and other characteristics for job openings. Provides consultative guidance to hiring managers on the recruiting process and...