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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.

Technical writer

Job Description

  • Location: Summit, NJ
  • Type: Contract
  • Job #67428

Our client, a leading pharmaceutical company is hiring a Technical Writer on a contract basis.

Work Location

Summit, NJ



The Technical Writer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory and clinical manufacturing operations through interaction with internal team members and internal customers as well as external service providers. As a developing team player, the technical writer interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The technical writer may be asked to lead small to medium sized projects in their area of responsibility and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The technical writer will be involved in writing deviations, investigations and supporting the implementation of change controls.


2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities


• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, eQRMS (reliance and veeva), and Outlook with extensive background in database systems. Innate ability to learn new software.

• Strong written and verbal communication skills. Highly proficient at writing wellformulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation.

• Excellent interpersonal skills with experience dealing with a diverse workforce.

• Strong multitasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.

• Ability to effectively manage multiple tasks and activities simultaneously.

• Familiarity with FDA and EU environments and associated compliance regulations.


• Problem Solving

• Team Player / Building Relationships

• Self-Driven

• MultiTasking

• Customer Focused

• Action and detail oriented



Essential Functions:

• Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation.

• Responsible for routing documents through the Celgene Document Management system.

• Facilitates periodic review of SOPs and provides subject matter expertise in documentation best practice.

• Responsible for documenting efficient procedural solutions to varied and complex challenges.

• Attends and participates in meetings and discussions to define and capture procedures and procedural changes.

• Writes and supports deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.

• Captures meeting notes and tasks and notifies key stake holders in a timely fashion.

• Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.

• Follows up with team members and cross functional team members to encourage timely review and approval.

• Promotes and provides excellent customer service and support.

• Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

• Adheres to all policies and procedures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.

• Promotes and provides excellent customer service and support.

• Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

Regulatory Responsibilities

• Maintains all required Corporate, Facilities and EHS training as required.

• Adheres to all safety procedures and hazard communication.

• May be called upon to act as SME in both internal and regulatory audits.



• BA / BS degree or acceptable combination of education and practical experience.

• Minimum 3 years experience as technical writer developing procedural documentation, interfacing with stakeholders to align different and potentially conflicting needs.

• Knowledge of cGMP in the pharmaceutical industry.

• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.

• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.



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