- Expiry Date: 01 August 2021
Purpose of the Position:
The ECQ VCI Technical Writer provides primary support for the organizations continuous improvement program by ensuring timely completion of document revision from a variety of inputs, including audit observations, interviews and individually driven assessment. The incumbent will draft, revise, review, route and approve multiple document types in an effort to ensure departmental and project milestones are met. With direction, this individual carries out routine tasks and functions. The individual works collaboratively with their immediate supervisor, team members and internal and external customers to achieve team and departmental goals.
Technical Writing Responsibilities:
Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation deliverables.
Responsible for routing document deliverables through the Celgene Document Management system.
May assist with writing deviations, CAPAs, Change Controls.
Facilitate periodic reviews of SOPs and provide subject matter expertise in documentation best practice
Responsible for assisting and facilitating in requirement gathering, documenting efficient procedural solutions to varied and complex challenges.
Attend and participate in meetings and discussions to define and capture procedures and procedural changes
Capture meeting notes and tasks and ensure timely distribution.
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
Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Support the team with additional administrative responsibilities as necessary.
Required Competencies‐Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint Visio and Outlook with extensive background in database systems. Innate ability to learn new software.
Strong written and verbal communication skills. Highly proficient at writing well‐formulated 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 multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high 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
Team Player / Building Relationships
Action and detail oriented
Education & Experience:
AA / AS 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.
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
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.
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.