What are the responsibilities and job description for the Technical Writing Specialist position at Cynet Systems?
Job Description:
Pay Range: $48hr - $51hr
Knowledge, Skills And Abilities:
Pay Range: $48hr - $51hr
Knowledge, Skills And Abilities:
- Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
- Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
- Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
- Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
- Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
- Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
- Ability to interact effectively with cross-functional groups.
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- Ability to effectively manage multiple tasks and activities simultaneously.
- Strong written and verbal communication skills, including solid presentation skills.
- Proficient at writing well-formulated emails and reports.
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
- Ability to effectively communicate with employees, contractors and vendors.
- Strong computer skills in Microsoft Office Suite – Word, Excel, Outlook and Teams, and the ability to learn new software as required.
- Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
- Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
- Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.
- Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
- Create all documents in compliance with standards and policies.
- Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
- BA/BS degree required, BS or more advanced degree in science/engineering preferred.
- Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry.
- Lab w/ blood & animal.
Salary : $48 - $51
Manager, X-TA Regulatory Medical Writing
Johnson & Johnson Innovative Medicine -
Raritan, NJ
