Job Summary:
The Laboratory Systems Administrator will be responsible for responsible for the oversight and administration of all laboratory computerized systems (standalone and enterprise) in a controlled pharmaceutical laboratory environment.
Responsibilities
- Lead and manage projects involving procurement, integration and implementation of new and upgrades of laboratory software, instruments, applications and information.
- Drive compliance, quality and safety in planning, implementing and maintaining of all new and existing validated/applicable computerized equipment, instruments and information systems.
- Create, revise, review, approve and/or provide input and guidance to Computer System Validation (CSV) documentation, validation related documents, change control documentation and Good Manufacturing Practices (GMP) documentation such as Standard Operating Procedures (SOPs) (where applicable).
- Promptly report deviations, and recommend and execute preventive and corrective actions to continuously improve the quality of laboratory.
- Create, coordinate, implement, and maintain data integrity policies in the laboratory to comply with regulatory guidance.
- Serve as the point of contact for troubleshooting/issue resolution of laboratory computerized.
- Develop and maintain knowledge and understanding of laboratory systems, equipment and instrumentation.
- Conduct timely backups of instrument electronic data for all laboratory computerized.
- Communicate and collaborate with laboratory management, business stakeholders, Information Technology (IT) department, technical resources and vendors using both oral and written communication.
- Multi-task by working on several simultaneous projects.
- Conduct user-training sessions for users.
- Participate in internal and external audits (when applicable), including Food and Drug Administration (FDA) and customer audits.
- Operate to the highest ethical and moral standards.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Comply with all cGMP requirements and Company policies, procedures, rules and regulations
- Operate in both an individual and team setting.
- Executes assigned tasks within established schedule.
Requirements:
- BSc/BA in computer science, engineering or relevant field
- 5+ years of experience in the pharmaceutical.
- Knowledge of pharmaceutical analytical laboratory procedures and USP.
- Experience working in pharmaceutical industry and/or analytical laboratory.
- Demonstrated experience with computer system validation and system lifecycle methodology.
- Independent experience and knowledge of the Empower Chromatography Data System.
- Knowledge of GMP, Industry Guidelines (ICH/FDA).
- Knowledge of 21CFR Part 11 compliance.
- Knowledgeable with MS Office applications (Word, Excel, Access, Outlook Excel).
Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.
Physical Requirements:
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Use arms, hands and fingers to handle, feel or reach.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
