LIMS

Hi

LIMS

Location: WALTHAM MA

Duration: 6 months

Laboratory Information Management System (LIMS)

Life Sciences : Computer System Validation

Healthcare Regulatory

Problem Solving Experience

Must Have Technical/Functional Skills

Expand the laboratory systems stack knowledge and understand local laboratory procedures.

Support and configure laboratory equipment inside Empower and other systems to ensure correct execution of laboratory testings.

Accurately translate business processes into technical terms and vice versa

Build and maintain awareness and knowledge of regulatory legal or quality requirements impacting the quality control laboratory and ensure that solution requirements comply

Deliver and support laboratory systems stack to start up new quality control lab operations inside the concord site.

Work with global system teams to ensure operational readiness of laboratory systems to support the operational objectives of the concord facility (i.e. validation plans standard operating procedures training etc.)

Produce and maintain project and validation documentation

Ensure systems remain in a validated state and manage their lifecycle through releases recapitalization and retirement

Ensure the incident problem configuration and change/release management are all accomplished in alignment with and understanding of business need

To have good experience on e3a and e3b instruments and Lab systems.

Roles & Responsibilities

Prior work experience working in pharma or other GMP setting

Strong working knowledge of quality control laboratory IDS systems

Solid knowledge of Computer System Validation process

Demonstrated ability to analyze anticipate and resolve complex issues (technical operational or business-related) through sound problem-solving skills

Effectively prioritize and escalate issues

Demonstrated learning agility and curiosity

Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions

Desire and ability to communicate using a variety of methods in diverse forums

Generic Managerial Skills If any

Resource should be quick learner and self-driven; capable of working with client partners to meet strategic Objectives

Resource must be able to identify mentor and hone talent to build leaders from within a team.

QC Administrator

Skills: EIS :