Our client, a world leading Pharmaceutical Company in Raritan, NJ is currently looking for a LIMS Master Data Analyst / Pharma Industry to join their expanding team.

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POSITION DETAILS:

Job Title: LIMS MASTER DATA ANALYST / PHARMA INDUSTRY

Duration: 6 months contract, extendable up to 24 months

Location: Raritan, NJ

NOTE:

Client has the RIGHT-TO-HIRE you as a permanent employee at any time during or after the end of contract.

You may participate in the COMPANY GROUP MEDICAL INSURANCE PLAN

JOB DESCRIPTION:

An Analyst 2, LIMS Master Data Analyst, Lab Systems works within the eLIMS CoE, and independently creates, updates and maintains high quality Master Data within eLIMS, integrates instruments and applications within eLIMS, performs user acceptance testing and translates specifications within the eLIMS system by utilizing current business processes.

The Analyst takes ownership by completing any incoming requests in a timely manner. They will escalate any issues and understand the impact towards other customers when changing / updating existing Master Data. In order to maintain high quality data, they collaborate with customers to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.

An Analyst 2 is able to mentor, lead, and train team members. The Analyst collaborates with more than 1 customer from the different platforms (e.g. LM, SM, PDMS,...) to fully understand the Master Data requirements and will review all configurations for accuracy and completeness. An Analyst 2 is able to lead small projects within the CoE, e.g. Harmonization / standardization of processes.

JOB REQUIREMENTS:

MAJOR DUTIES AND RESPONSIBILITIES:

75 -85 % - Creates, updates, reviews & approves Master Data (release and stability) including worksheet templates, worklist templates and sample plans

10 – 20% - Maintains system related documentation (procedures, events, etc) with the appropriate applications (Docspace, Trackwise, Clearquest, Client-ALM or any other designed system;

Participates in system related project activities as requested by the CoE lead including review and testing of system updates;

Coordinates eLIMS activities with the local labs; Updates eLIMS instrument master data, eLIMS Empower master data, eLIMS LES master data and uploads Smart QC Master Data; Creates test scripts for user acceptance testing, and executes user acceptance testing using customized test scripts from the local labs;

Participates in capability development activities according to training requirements; Provides feedback to CoE team lead regarding eLIMS activities performance

5 % - Provide feedback to CoE team lead regarding eLIMS activities performance

REQUIREMENT:

A minimum Bachelor's degree or equivalent education is required. The Analyst must have 3 – years experience. Knowledge & experience with LIMS is required.

They must have the ability to manage multiple issues, organize activities, prioritize and escalate to management when appropriate.

They must have broad knowledge and experience with cGMPs, regulations, risk management. Previous Quality Systems experience is required. Knowledge of/familiarity with other appropriate lab systems(Empower/SDMS/LES) is preferred.

The Analyst must have decent written and verbal communication skills (Basicin English – B2).

They must have experience working in a pharmaceutical or other highly regulated industry. Experience with quality assurance, quality control, analytical testing or IT is preferred.

The Analyst must be flexible to adapt to urgent needs.

They must have the ability to interact with Local lab leaders where necessary regarding master data related issues. They must have the ability to maintain a strong relationship with Local Labs and maintain a clear line of communication with the eLIMS CoE lead. They must have a strong customer focus and be dedicated to meeting customer expectations as determined by the CoE lead.

MAIN PURPOSE OF THIS ASSIGNMENT WILL BE WORKING WITHIN A REQUEST INBOX WITH THE FOLLOWING RESPONSIBILITIES:

The Analyst takes ownership when completing incoming requests in a timely manner. They will immediately escalate any issues and understand the impact towards other customers when changing / updating existing Master Data.

In order to maintain high quality data, they collaborate with customers to fully understand the Master Data their requirements and will review all configurations for accuracy and completeness.