LIMS Specialist/Administrator

Posted 01 November 2021
LocationCambridge
Job type Permanent
DisciplineLIMS
Reference28769
Contact NameDaniel Wallace

Job description

Purpose of role

The System Administrator serves as a quality system subject matter expert and will be responsible for overseeing the installation, management, upgrades, and support of laboratory systems. These include laboratory management (LIMS), chromatography data management (CDMS) and other instrument centric software. This individual will provide technical advice and support to end-users.

The System Administrator will apply analytical, communication, and problem-solving skills to help identify, communicate, and resolve issues. In addition, this individual will also be responsible for identifying and implementing system improvements to optimize performance and uptime in a manner consistent with organizational goals, industry best practices, and regulatory requirements (e.g. FDA, ICH).

Current Responsibilities:

  • All duties are performed independently with minimal supervision and oversight. Considered expert in quality and laboratory systems.
  • Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards.
  • Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.
  • Oversee implementation, configuration, maintenance, and upgrades of the electronic Laboratory systems such as LIMS and CDMS. This includes both global, site, and instrument based systems.
  • Troubleshoot software errors, document problems and resolutions, and assessing impact of issues.
  • Performs user/role access administration and account audits; Ensures change authorization and documentation is completed according to policy.
  • Configures and deploys enterprise-level components (e.g., Roles, Groups, Content Types, Templates, Process rules, workflows, custom field/value, reports, etc.) and migrates legacy system data\content to meet business requirements.
  • Conducts and supports software and hardware modifications using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.
  • Participate in system validation by drafting, reviewing and\or executing test scripts.
  • Maintains application Subject Matter Expert (SME) knowledge by staying current on software capabilities, issues, availability of new functionality, and updates from the software vendor.
  • Work effectively with teammates and collaborates to deliver quality solutions.
  • Provides system training to cross-functional departments.
  • Writes, reviews, and approves discrepancy reports (e.g., deviations, CAPAs, complaints, etc.).
  • Performs other related duties as assigned.

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and company policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of the business.
  • Travels as needed for professional conferences and training opportunities.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Qualifications/Skills Required:

  • BS/BA degree in a relevant life sciences discipline or equivalent.
  • Experience in a GMP oriented environment and Quality Control related activities.
  • The relevant amount of experience with electronic laboratory systems.
  • Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
  • Knowledge of industry standards and regulation requirements for biologics and paternal products in clinical development.
  • Demonstrated ability to successfully interface and provide guidance to multi-disciplined teams from project inception through project completion with respect to FDA requirements, agency and vendor audits, corrective actions, and complaint management.
  • Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
  • Skill in writing to effectively communicate complex ideas and concepts.
  • Detail oriented with strong analytical, written, and verbal communication skills.
  • Must be familiar with Microsoft Office applications.
  • Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.
  • Strong knowledge of systems and networking software, hardware, and networking protocols.
  • Experience with drafting, reviewing, and approving protocol scripts for software upgrades.
  • Direct experience with electronic lab systems (e.g., Biovia, LabWare, Empower, Open Lab, Lab Vantage, etc.) is preferred.