Document Facilitator/Technical Writer
Key Responsibilities and Major Duties
Write and revise Job Aids, standard operating procedures (SOPs) and work instructions for GMP Analytical and Microbiology laboratory operation and instruments.
Identify and interview cross functional subject matter experts and translate their description into actionable instructions- using the templates prescribed by corporate policy.
Schedule cross functional team meetings, collect accurate notes/feedback, create draft documents, post on sharepoint, schedule reviews, collect and resolve feedback.
Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
Work independently but recognize need to consult stake holders and keep them informed of progress by maintaining spreadsheet of all the documents in progress with different stages.
Give management weekly updates on the progress of activities.
Maintain a good understanding of ICH Guidelines, regulations and other guidelines applicable to GMPs.
Ability to negotiate and influence solutions without direct authority.
A self-starter with an ability to manage electronic systems with minimal training and supervision.
Requirements
Minimum of 5-8 years' experience in a GMP laboratory environment. At least 5 years' experience in writing and reviewing standard operating procedures.
Demonstrated ability to successfully manage competing deadlines and balance priorities.
Excellent technical writing skills, close attention to detail, taking notes and excellent follow up.
Expertise in Microsoft Word, Excel and Share Point.
Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
A local to Central NJ area who is able to work remotely during pandemic and able to work on site immediately without a delay in relocation once the site is open.
Must be resourceful and able to navigate through the IT set up, remote learning and working environment until the site is open.
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Last updated on Mar 2, 2021