Systems Administrator, Laboratory Systems
Apply NowCompany: Alora Pharmaceuticals
Location: Fort Worth, TX 76137
Description:
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.
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.