GxP Lab Computing Analyst

Description

Location:

Cambridge, MA
** This role will require full-time on-site presence at our client site in Cambridge, MA.
**** This role is NOT eligible for relocation assistance
** The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team.

Requirements

Required Skills:

Excellent customer service skills complemented by an ability to listen to and interpret client requests

Ability to troubleshoot complex instrument and technology issues

Strong oral and written communication skills

Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer’s site safety code Responsibilities:

As a Lab Computing Analyst, beneficiary would perform following key responsibilities:

Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges

Define scope Gather requirements.

Assist with Validation/Compliance activities (IOPQ) as required.

Analyze current state business processes and requirements.

Assist in building plans for process improvementIT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization

Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs

Customer Liaison:

Meeting with internal/external service groups/leads

Liaise between System/Lab owners and third parties to coordinate best times for services

Provide weekly planning schedules for review at status meeting with customer leads

Monthly Operational review meetings/ Quarterly metrics reporting with department heads

On Site Lab IT Support:

Perform break/fix support for all Instrument connected systems

Implement Windows based security policies as required

Ensure adherence to client’s corporate policies through periodic reporting & compliance programs

Acts as the technical support contact for field service engineers and external vendors

Provide technical subject matter expertise for new system validation and change management

Create and maintain a physical inventory of lab equipment, PC’s, software, and any other information pertinent to the environment if applicable

Perform system preventative maintenances based on client’s schedule, if applicable

Requirements

Bachelor’s/Master’s degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to);
Windows technologies, networking, remote computing and backup systems

At least 1 year in software development and testing.

At least 1 year of experience in business requirement analysis and gathering.

Demonstrated domain area knowledge.

Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client’s confidence and trust.

Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry:

Drug Discovery & Development Processes Clinical study planning & Data management

Lab Workflows Chemical & Biologics material Management Sample…