Senior GMP Technical Writer - QC Investigations Lead

Johnson & Johnson Co.; Titusville (NJ); Presencial; USD 79 000 - 128 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) plan

Pension plan

Long-term incentive program

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Analytical technologies

QC laboratory experience

Root cause analysis

Communication skills

cGMP knowledge

MS Office

Investigation writing

Ferramentas

Trackwise

COMET

Docspace

TruVault

eLIMS

Descrição da oferta de emprego

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.