Computer System Validation Specialist Job at JAF Consulting, Inc, Remote

MnlVaUhkZUtXQjZhc1Q3VlU2L0lMVzBad3c9PQ==
  • JAF Consulting, Inc
  • Remote

Job Description

Company Description

JAF Consulting, Inc. is a leading consultancy specializing in Global Quality and Regulatory Compliance Services for industries such as Pharmaceutical, Life Science, Nutraceutical, and Medical Devices. We offer Quality Assurance as a Service (QAaaS) and provide a range of services including Computer & Process Validation, GLP, GMP, and GCP QA, Quality Management, Auditing & Assessment, and Training & Education. Our mission is to deliver innovative, pragmatic, and top-quality services at reasonable prices, ensuring that our clients achieve and maintain compliance with relevant regulations and standards.

We are currently seeking a full-time remote Computer Validation Specialist. This role entails validating both laboratory and enterprise systems and ensuring sustained quality and compliance.

As a Computer Validation Specialist, you will:

  • Collaborate with client experts to document requirements by researching existing instrument/departmental documentation.
  • Develop validation deliverables to support compliance programs.
  • Formulate testable requirements for GLP, GMP, and GCP laboratory equipment, automation systems, or enterprise computerized systems.
  • Address open compliance issues through procedural controls.
  • Coordinate and assist in review processes with the Project Lead and QA Specialist.

Qualifications for this role include:

  • 7-10 years of experience in the Pharmaceutical and Life Science industry.
  • Knowledge of FDA regulations, particularly 21 CFR Part 58, 21 CFR Part 210 & 211, ICH E6(R3), and 21 CFR Part 11.
  • Familiarity with Quality Control (GMP), GLP, and GCP processes.
  • Ability to work independently and remotely.
  • Strong communication skills across all corporate levels.
  • Excellent analytical, interpersonal, and written/verbal communication skills.
  • Experience collaborating with project teams and managing multiple projects across functional areas.

Job Tags

Remote job, Full time,

Similar Jobs

Columbia Healthcare

Oral Surgeon needed in Rolla, MO Job at Columbia Healthcare

 ...About the Position We are seeking an Oral Surgeon to join our clinic in Rolla, MO. This role primarily focuses on serving the Medicaid population, offering essential care rather than elective procedures like high-end implants or facial cosmetic surgeries. Key... 

Autism Learning Partners

Program Manager (PM) - Center Based Job at Autism Learning Partners

 ...Reach, goal writing, clinical problem solving, CPT codes, telehealth assessments. Our Clinical Development team also offers weekly office hours or 1:1 support, as needed Education and Mentorship: Monthly CEUs and an annual in-house conference featuring leading researchers... 

Inveniam Search Consultants, Inc.

Employment Class Action/ PAGA Attorney Job at Inveniam Search Consultants, Inc.

 ...independently and as part of a team in a fast-paced environment. Demonstrated commitment to advocating for consumer rights and social justice. Benefits: Competitive salary commensurate with experience. Comprehensive benefits package, including health... 

Intermountain Health

Special Education Teacher Job at Intermountain Health

 ...position is responsible for identifying the educational needs of children and adolescents,...  ...treatment. This position reports to the Special Education Supervisor and is responsible...  ...therapeutic needs. The special education teacher is primarily responsible for identifying... 

St Jerome Church

Musician Job at St Jerome Church

Culturally diverse Catholic parish in an urban setting is seeking a Music Minister to play piano at the weekend liturgies.The position includes:1.Three weekend liturgies (Sat 5pm, Sun 8am and 11am)2. developing choirs3. cantor training4. playing for Holy Days, weddings...