Clinical laboratory technologist h1.location_city

POSITION OVERVIEW

The System Administrator, Laboratory Systems is a member of the corporate quality group responsible for

implementing and maintaining laboratory equipment at the Alora sites to ensure quality and regulatory

requirements are achieved (GAMP 5, cGMP, FDA 21 CFR Part 11). The System Administrator will also assist with

system and instrument validation / qualification. The sites include Fort Worth, TX and Marietta, GA.

DUTIES AND RESPONSIBILITIES

· Travel to Sites 50%

· Serve as an application level or system level administrator for laboratory equipment. Responsible for managing

the equipment lifecycle including delivery, integration, modification, and maintenance

· Lead the planning, execution, and documentation of laboratory equipment validation activities according to

regulatory requirements (GAMP 5, cGMP, FDA 21 CFR Part 11) and corporate policies by developing and

maintaining validation documentation including GxP Assessments, Change Controls, Validation Plans, Risk

Assessments, Requirements, Design/Functional Specifications, IQ/OQ/PQ Protocols, Trace Matrices, and other

documentation required for implementing and maintaining laboratory equipment and equipment software

· Coordinate vendor installations and the incorporate vendor validation documentation into the validation

process

· Perform periodic assessments of previously validated laboratory equipment, highlighting potential compliance

risks, and acting proactively to resolve issues

· Evaluate and assign appropriate user roles and privileges for data integrity (where applicable) for laboratory

equipment

· Author laboratory equipment administration and security procedures.

· Provide guidance on CSV best practices and ensure adherence to internal policies and industry standards

· Collaborate with IT, Quality Assurance, and other stakeholders to ensure alignment with project timelines and

objectives

· Develop and perform any required remediation effort and associated CAPA plan

· Support quality improvements related to regulatory agency observations and recommendations

· Consult or contribute to other validation projects as needed and time allowing

· Perform other duties as required

EXPERIENCE AND QUALIFICATIONS

· Bachelor's degree in Technology or Engineering discipline

· A minimum of 5 years’ experience in laboratory systems in pharmaceutical or related industry

· Position requires strong GMP compliance knowledge including knowledge of GAMP 5, 21 CFR Part 11, EU

Annex 11 among others

· Position requires knowledge of GxP Computer System Validation (CSV) activities and testing practices within

the Pharmaceutical Industry

· Ability to manage multiple projects simultaneously while performing day-to-day activities

· Ability to present technical information to management, employees, and other departments

· Self-motivated team player with exceptional organization, follow-through, time management, and

communication skills

· Excellent ability to write, review, edit, and approve technical or technical documentation

· Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management in the company Preferred Experience / Skills · Hands on working knowledge in Laboratory Information Management Systems and Quality Management Systems.