Senior Technical Writer
Johnson & Johnson Innovative Medicine
Summary
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.
Job description
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
Requirements
- 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, TruVault, eLIMS or equivalent required
- Able to communicate clearly at all levels of the organization required
- Ability to work independently on assignments with minimal oversight required
Benefits
- Pension plan
- 401(k) savings plan
- Long-term incentive program
- Vacation
- Sick time
- Holiday pay
- Floating holidays
- Parental leave
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Military spouse time-off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.