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Technical Writer

  • Location: Summit, Union, New Jersey
  • Job Type:Contract

Posted 21 days ago

  • Expiry Date: 08 August 2021

Job Description:

PURPOSE AND SCOPE OF POSITION:

  • 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.

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.

Competencies:

  • Problem Solving

  • Team Player / Building Relationships

  • Self-Driven

  • MultiTasking

  • Customer Focused

  • Action and detail oriented

DUTIES AND RESPONSIBILITIES:

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.

EDUCATION AND EXPERIENCE

  • 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.

WORKING CONDITIONS:

PHYSICAL / MENTAL DEMANDS:

  • Ability to sit, stand, walk and move within workspace for extended periods.

  • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.

ENVIRONMENTAL CONDITIONS:

  • Primarily office environment.

  • Ability to work safely and effectively when working alone or working with others

 About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.