Job Description

Job Description

Job Description

SUMMARY/OBJECTIVE:

The Technical Writer, Analytical is responsible for supporting and coordinating Quality Management System (QMS) documentation activities for the laboratory and Analytical functions. This role will partner closely with laboratory personnel and Quality Assurance to draft, revise, route, and maintain compliant GMP laboratory documentation supporting analytical testing and development activities. This individual will serve as a key liaison between Analytical R&D and Quality Assurance for laboratory quality documentation and related quality system activities. The role requires strong technical writing capabilities, scientific comprehension, and familiarity with GMP laboratory documentation practices in a regulated pharmaceutical or CDMO environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Drafts, revises, formats, and coordinates-controlled laboratory documentation including:
  • SOPs
  • Test methods
  • Specifications
  • Analytical procedures
  • Forms
  • Protocols
  • Laboratory worksheets
  • Validation documentation
• Coordinates document review and approval workflows between Analytical R&D and QA.
• Supports document control activities within the electronic QMS/document management system.
• Assists with laboratory-related deviations, investigations, CAPA, and change control documentation.
• Partners with laboratory personnel to ensure procedures accurately reflect current analytical practices and regulatory requirements.
• Supports data integrity and GDP compliance initiatives within laboratory documentation practices.
• Assists with maintaining inspection-ready documentation and audit preparedness.
• Coordinates document revisions, periodic reviews, archival activities, and implementation of updated procedures.
• Supports onboarding and training documentation activities related to laboratory procedures.
• Maintains organized documentation records in accordance with company procedures and regulatory expectations.
• Participates in continuous improvement initiatives related to laboratory documentation and quality systems.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree preferred in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, Technical Writing, or related discipline.
• Minimum 2–5 years of experience in pharmaceutical, biotechnology, medical device, or other regulated GMP laboratory environments.
• Experience authoring and/or coordinating GMP laboratory documentation required.
• Familiarity with analytical laboratory operations and documentation practices preferred.
• Experience with Quality Management Systems (QMS) and electronic document management systems preferred.
• Working knowledge of cGMP, GDP, FDA regulations, and data integrity expectations required.

COMPETENCIES/SKILLS:

• Strong technical and scientific writing skills.
• Ability to interpret analytical and laboratory processes into compliant documentation.
• Excellent attention to detail and organizational abilities.
• Strong collaboration and communication skills across technical and quality teams.
• Ability to manage multiple projects and documentation timelines simultaneously.
• Proficiency in Microsoft Office applications and electronic quality/document management systems.
• •Understanding of GMP laboratory documentation requirements and data integrity principles.

SUPERVISORY RESPONSIBILITIES:

• None

SCHEDULE:

• Hybrid: 4 days in office in Cranbury, NJ office; 1-day WFH.

SALARY RANGE:

• $100,000 - $130,000

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 50 pounds frequently.
• 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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