Vacancy expired!
Sunrise System Inc. is currently looking for
Technical writer in New Brunswick, NJ with one of our top client.Job Title: Technical writerJob Id: 21-09088Location: New Brunswick, NJ 08903Duration: 12 monthsPosition Type: Hourly contract Position (W2 only)- Manager will consider non local candidates But prefers local candidates. An individual who is able to report onsite when once COVID restrictions are lifted.
- Ability to use Microsoft Office Suite (especially WORD)
- Pharm/Bio Tech regulated Background
- Work with a variety of people/flexible in the mindset
- The technical writer positions are responsible to prepare technical documents for global use within Operational Controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution, and Governance Controls: Management Responsibilities, Training & Qualification, Event Management, Document & Change Management, Quality Risk Management.
- Excellent technical writing skills.
- Expert in MS Office and Collaboration applications.
- Experience with electronic documentation management systems (preferable, not required)
- Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
- Strong verbal and written communication skills
- Project management concepts, strategies and skills
- Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures
- In depth knowledge of cGxP requirements (includes GMP, GDP, Google Cloud Platform, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement.
- Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
- Strong negotiating and influencing skills in a matrixed
- Ability to drive consensus, performance and to lead strategically
- High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas
- Ability to participate on teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner
- Demonstrated ability to work independently
- Includes, but not limited to, document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
- Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.
- Support Global Product Development & Supply organization for Client electronic document management system.
- Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes
- Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
- Effectively participate on projects, escalate issues as necessary and identify/meet key milestones
- Work with limited guidance to manage the development of global procedural documents and, seek input as needed
- Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
- Ability to identify, manage, and/or escalate issues and risks to timelines
- Collects and shares best practices through direct communications and communities of practice
- Minimum of a Bachelor's degree
- 5+ years experience in the Biopharm/Pharmaceutical industry
Vacancy expired!