Senior Technical Writer

Johnson & Johnson • Titusville, NJ

1d

About The Position

The Senior Technical Writer drives technical writing of GMP documents and investigations for NJ Stability Lab Operations in a fast-paced, multifaceted environment. The work ranges in complexity and requires sound judgment, initiative, and problem-solving. All writing and investigations must comply with applicable procedures, standards, GMP requirements, and relevant local, state, federal, and international regulations and guidelines, including FDA, EPA, DEA, and OSHA requirements.

The role develops and edits laboratory investigation records, SOPs, validation protocols and reports, forms, analytical documents, and other technical reports. It also supports documentation gap assessments, data review and trending, corrective and preventive actions, escalations, health authority inspections, training and mentorship, and continuous improvement. The writer collaborates with laboratory supervisors, QC Technical Leads, investigation teams, management, and global project teams, and may lead work or provide subject-matter expertise on complex issues.

Requirements

• Detailed knowledge of analytical technologies used in QC laboratories, such as HPLC, dissolution, IR, and Karl Fischer.
• Experience working in a QC laboratory as a bench analyst.
• Demonstrated use of root-cause analysis tools such as Kepner-Tregoe, Fishbone, and 5-Why.
• Strong written, verbal, and interpersonal communication skills, with close attention to detail.
• Knowledge and understanding of current GMP requirements related to QC laboratories.
• Basic knowledge of compendial requirements such as USP, EP, and JP pertaining to the functional area of QC.
• Advanced technical writing skills.
• Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
• Ability to complete investigations, including identifying root cause.
• Ability to collaborate and lead and influence investigation team members to coordinate work according to priorities.
• Experience with quality systems such as Trackwise, COMET, Docspace, TruVault, eLIMS, or equivalent.
• Ability to communicate clearly at all levels of the organization.
• Ability to work independently on assignments with minimal oversight.

Nice To Haves

• Analytical reasoning.
• Business behavior.
• Compliance management.
• Controls compliance.
• Cross-functional collaboration.
• Innovation.
• ISO 9001.
• Persistence and tenacity.
• Problem solving.
• Process-oriented approach.
• Quality auditing.
• Quality Control (QC).
• Quality control testing.
• Quality standards.
• Quality systems documentation.
• Report writing.
• Technological savvy.

Responsibilities

• Plan, execute, and write laboratory investigations with laboratory supervisors and QC Technical Leads; identify immediate and root causes and determine effective corrective and preventive actions.
• Write and edit SOPs, validation protocols and reports, forms, analytical documents, and technical reports from conception through utilization.
• Proofread documents for content, nonstandard formatting or wording, and errors.
• Review data as needed for documents being drafted.
• Participate in technical-documentation gap assessments, verify that methods meet current standards and investigated processes are present and functioning, and recommend solutions to address gaps.
• Present authorship strategies to management for pre-approval and endorsement.
• Build and maintain a progress-tracking matrix for document generation, qualification execution, document review, and approval; escalate issues or delays to management as appropriate.
• Collect and trend historical data.
• Prepare technical documentation for highly complex issues, including high-impact investigations.
• Contribute to improvements in laboratory investigation processes and templates.
• Train and mentor new investigation writers and laboratory analysts on technical writing.
• Maintain individual training completion in a compliant state.
• Complete investigation records and CAPAs in a timely and compliant manner.
• Provide information and support for escalations associated with laboratory investigations.
• Serve as a subject-matter expert for health authority inspections.
• Provide input to functional laboratory meetings.
• Contribute to and occasionally lead continuous improvement teams.
• Provide leadership and insight as a member of global project teams.

Benefits

• Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility to participate in the long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
• 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 a child's birth, adoption, or foster care placement.
• 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 period.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time off: 80 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed