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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

BUSINESS OR SYSTEMS ANALYST

Job Description

  • Location: Warren, NJ
  • Type: Contract
  • Job #72018

Our client, a leading pharmaceutical company, is hiring a Business or Systems Analyst on a contract basis.

Work Location

Warren, NJ

Summary

The primary focus of the Systems Analyst will be to define, develop, deliver and support GXP and non GXP Enterprise and Stand-Alone computerized systems associated with Cell Therapy Clinical manufacturing and development. This role will have a primary emphasis on support computerized systems (Labware LIMS, Flow Cytometry, PCR & ELN) and will work effectively with other IT groups, engineers and the business stakeholders to support computer systems in both manufacturing and development.

Key Responsibilities

 

1. Manage Benchtop IT system engineers (internal and external) at appropriate level to deliver workload:

• Manage vendor relationships as needed, ensure support is available to the Warren Cell Therapy Facility.

• Ensure all systems are consistently maintained in an audit ready state.

 

2. Collaborate with other Digital Plant leaders to address issues; develop plans to drive down support volumes for Cell Therapy benchtop IT systems.

3. Manage organizational adoption of client standard processes and systems including Vitalize; continuously enhance existing processes to simplify support requirements.

4. Foster business and enterprise partner relationships to ensure a high customer satisfaction rating.

5. Represent Benchtop IT (both Manufacturing, QC and Product Development) systems during internal audits and regulatory inspections.

6. Provide updates to management through established mechanisms.

7. Actively participate in all phases of application implementation, including the ownership of key deliverables IQ/OQ/PQ/UAT documents.

8. Assure quality customer service to all customers, promote positive service relationships and contribute to supportive and cooperative work environment

9. Assist project teams with technical issues in the Initiation and Planning phases of System Validation Lifecycle. These activities include the definition of needs, benefits, and technical strategy; research & development within the project life cycle; technical analysis and design; and support of operations staff in executing, testing and rolling-out the solutions

 

Qualifications & Experience

1. Bachelors degree or equivalent experience in a technology or engineering focused domain.

2. A minimum of 5-7 years of lab and quality systems and laboratory instrument PC support or related experience, documented by a solid history of technical accomplishments and a proven track record in implementing system software.

3. Commanding knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices

4. Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the ability to work and manage within a regulatory environment.

5. Proven implementation and life cycle planning of lab and quality systems or similar), support of cyber security actions, upgrade of instrument PCs and peripherals.

6. Understanding of network, databases, servers, and PCs.

7. Proven leadership skills and the ability to negotiate in a complex environment.

8. Excellent verbal and written communication skills.

9. Demonstrated Project Planning and Management skills

 

 

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