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 DUTIESAND 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 including:
• SOPs
• Batch records
• Forms
• Work instructions
• Logbooks
• Protocols
• Training 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.

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:

• $80,000 - $110,000

WORK ENVIRONMENT:

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

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• The employee must be able to lift and/or move up to 25 pounds.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral
• vision, depth perception and ability to adjust focus.

TRAVEL:

Less than 5% of the time.

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