Senior Technical Writer

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; Titusville (NJ); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Long-term incentive program

Job summary

Johnson & Johnson seeks a Technical Writer for the NJ Stability Lab Operations to lead GMP documentation and investigations, ensuring compliance with cGMP and regulatory guidelines. You will drive authoring of SOPs, validation protocols and reports from conception to utilization.

You will proofread, review data, and participate in gap assessments to maintain current standards while supporting audit readiness and continuous improvement in laboratory documentation.

Qualifications

• Detailed knowledge of analytical technologies used in QC labs (HPLC, Dissolution, IR, Karl Fischer).
• Experience in a QC lab as a bench analyst.
• Demonstrated use of root cause analysis tools (Kepner-Tregoe, Fishbone, 5-Why).
• Strong written, verbal, and interpersonal communication with attention to detail.
• Knowledge of cGMP related to QC labs.
• Basic knowledge of compendial requirements (USP/EP/JP).
• Advanced technical writing skills.
• Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).
• Ability to identify root causes and lead investigations.
• Ability to lead and coordinate investigation teams.

Responsibilities

• Plan, execute, and write laboratory investigations with supervisors and QC Leads.
• Write and edit SOPs, validation protocols/reports, forms, and technical documents from conception to utilization.
• Proofread documents for content, formatting, and errors.
• Review data pertinent to documents being drafted.
• Participate in gap assessments to ensure methods meet current standards and processes are optimized.
• Present authorship strategy for pre-approval and endorsement.
• Maintain a progress-tracking matrix for document generation and approvals.
• Collect and trend historical data.
• Prepare technical documentation for highly complex issues (high impact investigations).
• Mentor new investigation writers and lab analysts in technical writing.

Skills

Analytical technologies

QC laboratory experience

Root cause analysis

Communication skills

cGMP knowledge

MS Office

Investigation writing

Tools

Trackwise

COMET

Docspace

TruVault

eLIMS

Job description

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 MedTech, 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. Learn more at jnj.com

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.

Job Function: Quality

Job Sub Function: Quality Control

Job Category: Professional

All Job Posting Locations: Titusville, New Jersey, United States of America

Job Description

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

Required Knowledge, Skills and Abilities

• 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

Preferred Skills

• Analytical Reasoning
• Business Behavior
• Compliance Management
• Controls Compliance
• Cross-Functional Collaboration
• Innovation
• ISO 9001
• Persistence and Tenacity
• Problem Solving
• Process Oriented
• Quality Auditing
• Quality Control (QC)
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Report Writing
• Technologically Savvy

Salary

The anticipated base pay range for this position is : $79,000.00 - $127,650.00

Retirement and Incentive Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.

Time Off Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year
• for employees who reside in the State of Colorado –48 hours per calendar year
• for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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 MedTech, 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. Learn more at https://www.jnj.com/.