Technical Writer

ClinLab Solutions Group; North Brunswick Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical firm in North Brunswick Township is seeking a Technical Writer to manage GMP documentation and ensure compliance with FDA and regulatory requirements. The ideal candidate will have a Bachelor's degree in a related field and 2-5 years of technical writing experience in a regulated environment. Responsibilities include authoring Master Batch Records and collaborating with cross-functional teams to enhance document quality. This full-time role offers growth opportunities in a dynamic industry.

Qualifications

• Bachelor's degree preferred in a related field such as Pharmaceutical Sciences, Chemistry, or Engineering.
• 2-5 years of technical writing experience in a GMP-regulated environment.
• Hands-on experience with batch record preparation and review is strongly preferred.

Responsibilities

• Author and maintain Master Batch Records and Executed Batch Records for manufacturing.
• Collaborate with SMEs to create clear and compliant documentation.
• Review batch records for compliance with cGMP and internal standards.

Skills

Excellent written and verbal communication skills

Attention to detail

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Proficiency in Microsoft PowerPoint

Experience with document control systems

Education

Bachelor’s degree in Pharmaceutical Sciences or related field

Equivalent experience in a regulated environment

Tools

Dot Compliance

MasterControl

Veeva

Job description

Scientific Recruiter | ClinLab Solutions Group

Position Summary

The Technical Writer is responsible for authoring, reviewing, and maintaining high-quality GMP documentation, including master and executed batch records, SOPs, protocols, reports, and related technical documents. This role ensures compliance with FDA, EU, and ICH regulatory requirements and works cross-functionally with Manufacturing, Quality, Engineering, and Project Management to translate process knowledge into clear, accurate, and compliant documentation.

Key Responsibilities

Document Creation & Management

• Author, revise, and maintain Master Batch Records (MBRs) and Executed Batch Records (EBRs) for clinical and commercial manufacturing.
• Develop and update engineering and qualification documentation for new and existing equipment and facilities.
• Create and maintain SOPs, work instructions, logbooks, and other GMP documentation.
• Ensure documents are formatted using approved templates and comply with internal document control procedures and regulatory expectations.
• Collaborate with subject matter experts (SMEs) to translate complex technical information into clear, concise, and user-friendly documents.

Batch Record Review

• Review executed batch records for accuracy, completeness, and compliance with cGMP and data integrity requirements.
• Identify, document, and help resolve discrepancies or errors in coordination with Manufacturing and Quality teams.
• Support timely batch record review and turnaround to meet product release timelines.

Compliance & Quality Support

• Ensure documentation complies with FDA 21 CFR Parts 210/211, ICH Q7, EU Annex 1, and internal quality standards.
• Support internal and external audits by providing controlled documentation and ensuring manufacturing record readiness.
• Participate in change control, CAPA, and deviation documentation activities as required.
• Support implementation and use of electronic documentation systems (e.g., Dot Compliance) and participate in document migration initiatives.
• Identify opportunities to improve document clarity, efficiency, and traceability across manufacturing and quality operations.

Qualifications

Education

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Engineering, Technical Writing, or a related field preferred.
• Equivalent experience in a regulated pharmaceutical or biotechnology environment may be considered.

Experience

• 2–5 years of technical writing experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Hands‑on experience with batch record preparation and review strongly preferred.
• Working knowledge of cGMP documentation standards and regulatory requirements (FDA, EMA, ICH, EU Annex 1).

Skills

• Excellent written and verbal communication skills with strong attention to detail.
• Proficiency in Microsoft Word, Excel, PowerPoint, and document control systems (e.g., Dot Compliance, MasterControl, Veeva).

Seniority Level

• Associate

Employment Type

• Full-time

Job Function

• Accounting/Auditing and Writing/Editing

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing