Manufacturing Technical Writer # JN -072021-67560

Key Responsibilities and Major Duties:

• Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.
• Ability to interview cross functional subject matter experts and translate their description into actionable instructions- Work Instructions, Job Aids using the templates prescribed by corporate policy.
• Schedule cross functional team meetings, collect 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.
• Identify and lead improvement efforts within current procedures.
• 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.
• Experience with microbiology testing is a plus.
• Demonstrated ability to successfully manage competing deadlines and balance priorities.
• Excellent technical writing skills, close attention to detail and excellent follow up.
• Expertise in Microsoft Word 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.

Additional Job Requirements:      

• None