Technical Writer Operations

Experic LLC; Cranbury Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Experic LLC is seeking a Technical Writer based in Cranbury Township, NJ. This role involves drafting and maintaining GMP documentation in collaboration with Operations and Quality Assurance teams. Candidates should have a Bachelor’s degree and over 3 years of relevant experience in a regulated GMP environment.

The position offers a salary range of $80,000 to $110,000, primarily in an office setting. Strong technical writing abilities and meticulous attention to detail are essential.

Qualifications

• 3+ years of experience in a GMP environment.
• Experience leading Root Cause Analysis.
• Familiarity with cGMP requirements and FDA regulatory expectations.

Responsibilities

• Lead deviation and complaint Root Cause Analysis and CAPA.
• Draft, revise, and format GMP documentation.
• Ensure documents are compliant and inspection ready.

Skills

Technical writing

Attention to detail

Organizational skills

Collaboration

GMP knowledge

Document management

Education

Bachelor’s degree in Life Sciences, Engineering, Technical Writing or related field

Tools

Microsoft Office

Electronic document management systems

Job description

SUMMARY/OBJECTIVE

The Technical Writer is responsible for leading Quality Management System (QMS) documentation activities within Operations. This role will partner closely with Manufacturing, Packaging, Warehouse, Facilities, and Quality Assurance teams to draft, revise, route, and maintain controlled documentation in support of compliant GMP operations. This position serves as a key liaison between Operations and Quality Assurance. The role requires strong technical writing skills, attention to detail, organizational abilities, and familiarity with cGMP documentation practices in a regulated CDMO environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Leads deviation and complaint Root Cause Analysis and CAPA development for GMP investigations.
• Leads change control documentation activities related to Operations.
• Drafts, revises, formats, and coordinates controlled GMP documentation.
• Coordinates document review, approval, and implementation activities between Operations and QA.
• Partners with cross‑functional departments to ensure documentation reflects current operational practices and regulatory expectations.
• Supports document control activities within the electronic QMS/document management system.
• Assists with document periodic reviews, revisions, obsolescence activities, and version control.
• Ensures documentation is accurate, compliant, clear, and inspection ready.
• Assists with maintaining GMP documentation standards and data integrity expectations.
• Coordinates with QA regarding documentation corrections, audit findings, and continuous improvement initiatives.
• Supports internal and external audit readiness activities.
• Participates in operational meetings and provides documentation support for process improvements and new implementations.
• Maintains organized records and documentation archives in accordance with company procedures.
  • SOPs
  • Batch records
  • Forms
  • Work instructions
  • Logbooks
  • Protocols
  • Training documentation

QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree preferred in Life Sciences, Engineering, Technical Writing, or related field; equivalent experience may be considered.
• 3+ years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Experience leading GMP investigation, including Root Cause Analysis methodologies, required.
• Experience authoring and/or coordinating GMP documentation required.
• Familiarity with cGMP requirements, GDP principles, and FDA regulatory expectations required.
• Prior experience supporting GMP manufacturing and packaging, strongly preferred.
• Experience working with Quality Management Systems (QMS) and document control systems preferred.

COMPETENCIES/SKILLS

• Strong technical writing and document formatting skills.
• Excellent attention to detail and organizational skills.
• Ability to manage multiple document workflows and timelines simultaneously.
• Strong collaboration and communication skills across departments.
• Working knowledge of GMP documentation standards and data integrity principles.
• Proficiency in Microsoft Office applications and electronic document management systems.
• Ability to interpret operational processes and translate them into compliant written procedures.

SUPERVISORY RESPONSIBILITIES

• None

SCHEDULE

• In Office Role: 5 days in office in Cranbury, NJ office

SALARY RANGE

• Mid/Senior level – 3+ years: $80,000 - $110,000

WORK ENVIRONMENT

• Office Environment (standing and sitting) requires minimal physical exertion.

PHYSICAL DEMANDS

• Frequent standing, walking, use of hands, and hearing.
• Occasional sitting, reaching, and light lifting up to 25 pounds.
• Required vision capabilities include close, distance, color, peripheral, depth perception, and focus adjustment.

TRAVEL

Less than 5% of the time.

This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.