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.
1) Technical Writing Responsibilities: a. Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation deliverables. b. Responsible for routing document deliverables through the Document Management system. c. May assist with writing deviations, CAPAs, Change Controls. d. Facilitate periodic reviews of SOPs and provide subject matter expertise in documentation best practice e. Responsible for assisting and facilitating in requirement gathering, documenting efficient procedural solutions to varied and complex challenges. f. Attend and participate in meetings and discussions to define and capture procedures and procedural changes g. Capture meeting notes and tasks and ensure timely distribution. 2) Tracking Responsibilities a. Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc. b. Follows up with team members and cross functional team members to encourage timely review and approval. 3) Promotes and provides excellent customer service and support a. Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests. b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met. c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment. Required Competencies‐
Knowledge, Skills, and 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 Competencies: • Problem Solving • Team Player / Building Relationships • Self-Driven • Multi‐tasking • Customer Focused • 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. Working Conditions: 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. Environmental Conditions: • Primarily office environment • Ability to work safely and effectively when working alone, or working with others.
Montclair, NJ, 07042