Sr. Tech. Writer - Stability.

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Job description

Janssen Supply Group, LLC Part of the Janssen Pharmaceuticals Inc and Johnson & Johnson Family of Companies, is recruiting for a Sr. Tech. Writer - Stability, to be based either in Raritan NJ or Titusville NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow

Summary

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.)

Responsibilities

• Provide project/study and investigation support through review and technical writing of GMP documents (e.g. study specific protocols or validation reports), SOPs and other documents associated within QC area of responsibility
• Uphold our Credo values including creating a positive work environment
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying assignable/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
  
  

Qualifications

• A minimum of a University / Bachelor's Degree is required
• A minimum of four (4) years of relative work experience is required
• Detailed knowledge of analytical technologies used in the QC laboratory (HPLC, Dissolution, IR, Karl Fischer, etc.) is required
• Experience working in an analytical chemistry lab as a bench analyst is required
• Demonstrated use of root cause analysis tools such as Kepner-Tregoe, Fishbone, 5-Why, etc. is required
• Demonstrated written, verbal, and interpersonal communication skills with strong attention to detail is required
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory is required
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is required
• Advanced technical writing skills are required
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required
• Ability to complete investigations including identification of root cause is required
• Ability to work collaboratively and to lead and influence investigation team members to coordinate work based on priorities is required
• Experience with Quality Systems such as TrackWise, DocSpace, TruVault or equivalent required.
• Able to communicate clearly at all levels of the organization required
• Ability to work independently on assignments with minimal oversight required
• Prior experience in a regulated quality environment is required
  
  

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-New Jersey-Raritan-1000 US HIghway 202

Other Locations

North America-United States-New Jersey-Titusville

Organization

JANSSEN SUPPLY GROUP, LLC (6046)

Job Function

Quality

Requisition ID

W