Senior Technical Writer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

The Technical Writer is responsible for driving results in a fast-paced multi-faceted environment by leading the technical writing of GMP documents and investigations associated within the NJ Stability Lab Operations. Assignments are of varying complexity, where sound judgment and self-drive/initiative are required to resolve problems and make recommendations/decisions. This position requires technical writing and investigations to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)

• Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying immediate/root causes and determining effective corrective and preventative actions
• Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization
• Proofread documents for content and identify non-standard format or wording, and errors within documents
• Review data where required pertaining to documents being drafted
• Participate in gap assessments of technical documentation to ensure methods are up to current standards, and that processes investigated are present and functioning optimally. Provide recommendations/solutions to remediate any recognized gaps
• Present authorship strategy to management to get pre-approval and endorsement
• Build and maintain a progress-tracking matrix on document generation, qualification execution, document review and approval (Escalate any issue/delay to management as applicable)
• Collect and trend historical data
• Responsible for preparing technical documentation for highly complex issues (i.e. high impact investigations)
• Make contributions to improved processes and templates as it relates to laboratory investigations
• Provide training and mentorship for new investigation writers and lab analysts as it pertains to technical writing
• Maintain individual training completion in a compliant state
• Complete investigation records and CAPAs in a timely and compliant fashion
• Provides information and support to escalations associated with laboratory investigations
• Support as SME for Health Authority Inspections
• Provide input to functional laboratory meetings
• Make contributions to, and occasionally lead, continuous improvement teams
• Provide leadership and insight as a member of global project teams

• Detailed knowledge of analytical technologies used in the QC laboratory (HPLC, Dissolution, IR, Karl Fischer, etc.)
• Experience working in a QC laboratory as a bench analyst
• Demonstrated use of root cause analysis tools such as Kepner-Tregoe, Fishbone, 5-Why, etc.
• Demonstrated written, verbal, and interpersonal communication skills with strong attention to detail
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Advanced technical writing skills
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
• Ability to complete investigations including identification of root cause
• Ability to work collaboratively and to lead and influence investigation team members to coordinate work based on priorities.
• Experience with Quality Systems such as Trackwise, COMET, Docspace, Tru Vault, eLIMS or equivalent required
• Able to…