Direct Writer Jobs (NOW HIRING)

Our client is a Pharmaceutical is a technology-focused contract development and manufacturing
organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated
expertise in controlled substances manufacturing. With facilities in the United States and Canada,
supports leading pharmaceutical companies through high-quality manufacturing,
operational excellence, and customer-focused solutions.
The Technical Writer, Sterile Operations will develop, revise, and maintain
the documentation backbone for this facility - including Standard Operating Procedures (SOPs),
forms (FRMs), Master Batch Records (MBRs), and supporting logs - covering the full sterile
process flow: bulk, sterile filtration and filter integrity testing, sterile filling, VHP
decontamination, parts washing, autoclaving, and facility cleaning/environmental monitoring
(ISO 5/7/8). This role also provides direct writing support to Operations and Quality during
deviation investigations, ensuring documentation is clear, technically accurate, inspection-ready,
and aligned with cGMP and applicable DEA-adjacent controlled-space requirements.
KEY RESPONSIBILITIES
* Author, revise, and format SOPs and associated forms (FRMs) for sterile operations, including
bulk formulation, sterile filtration, aseptic filling, VHP decontamination, parts
washing/autoclaving, and cleaning/environmental monitoring.
* Translate input from Operations, Validation, Quality, and Engineering SMEs into clear, step
by-step, inspection-ready procedures consistent with cGMP and site document control
standards.
* Manage document lifecycle (new, revision, periodic review, retirement) and control multiple
concurrent revisions while preserving accuracy of source content and integrated changes.
* Edit, standardize, and harmonize documentation prepared by other authors or SMEs for
consistent terminology, style, and formatting across the sterile facility document set.
Batch Record Authoring
* Develop and maintain detailed Master Batch Records (MBRs) and Master Packaging/Batch
Records (PBRs) for sterile drug product, based on complex technical input from Product
Development, Operations, Validation, and Quality.
* Ensure batch records accurately reflect approved processes, equipment, in-process controls,
and critical process parameters.
* Maintain revision control and traceability for batch records, incorporating specific, requested
changes from Operations, Validation, and Quality with full accuracy of original content.
* Support review of executed batch records for documentation clarity and completeness ahead
of QA release.
Investigation Support
* Provide direct writing and documentation support for deviation investigations, discrepancies,
and CAPA records originating from sterile operations, in collaboration with Operations and
Quality Assurance.
* Assist in drafting clear, thorough, and well-organized investigation narratives,
background/scope sections, and corrective/preventive action documentation using site
investigation tools and quality risk management principles.
* Collaborate with SMEs and QA to capture root cause analysis, impact assessments, and
lessons learned in accurate, audit-ready written form.
* Support trending and documentation needs related to recurring deviations, environmental
monitoring excursions, and equipment/utility events specific to the sterile suite.
Pay $45.00 - $50.00/hr
Position Qualifications
* Accuracy - Ability to perform detailed technical writing work accurately and thoroughly.
* Regulatory/GMP Knowledge - Working knowledge of cGMPs and sterile/aseptic
manufacturing concepts sufficient to write and review technical documentation.
* Adaptability - Ability to adapt to a new facility start-up environment with evolving
procedures and priorities.
* Communication - Strong technical writing and editing skills; ability to translate complex,
technical, or scientific input into clear, concise procedures and records.
* Detail Oriented - Ability to identify and correct minute inconsistencies in records, forms, and
batch documentation.
* Organized - Self-motivated, systematic approach to managing multiple documents, revisions,
and deadlines.
* Investigation Writing - Ability to write clear, logical investigation narratives and support root
cause/CAPA documentation.
* Collaboration - Ability to build effective working relationships with Operations, Validation,
Quality, and Engineering SMEs.
* Proficiency in Microsoft Word and Excel; experience with electronic document management
systems (e.g., Master Control) and quality/investigation systems (e.g., TrackWise) preferred.
* May be required to move about the sterile facility and gown/degown per site procedures.
* Must be able to remain sedentary for periods of time.
* May be required to wear personal protective equipment, including cleanroom garb, in
classified areas.
EDUCATION:
Bachelor"s degree (four-year college or university) in a scientific, engineering, or related technical
discipline; equivalent industry experience considered in lieu of degree.
EXPERIENCE:
* Two to five years of related experience, preferably in pharmaceutical or sterile/aseptic
manufacturing.
* Experience in batch record preparation, SOP authoring, and technical report writing in a
cGMP environment.
* Experience supporting or writing deviation investigations, RCA, and CAPA documentation
strongly preferred.
* Familiarity with sterile/aseptic processing concepts (isolator technology, VHP
decontamination, aseptic filling, environmental monitoring) a plus.
* Experience with quality/investigation tracking systems (e.g., TrackWise) preferred.
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