Newark Metro Area, NJ
1) Technical Writing Responsibilities:
a. Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation.
b. Responsible for routing documents through the Celgene Document Management system.
c. Write 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. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
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.