Chat with me now! – https://flashrecruit.com/jobs/298781

Manufacturing Support – Technical Writer

Job Summary

This role is an exciting opportunity to be a critical part of a high growth organization that is radically changing the biotech industry. Currently, the client is building a state-of-the-art, LEED certified, cGMP manufacturing facility in Norwood, MA. This 200k sq. foot campus is critical as we continue to move more of our therapies into the clinic and require in-house manufacturing. The client is seeking a cGMP Manufacturing Support team member focusing on technical writing for our new site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. The Manufacturing Support Technical Writing team member uses knowledge of cGMP regulations and biopharmaceutical production processes to create and revise standard operating procedures, batch records, specifications, forms and other critical documentation. They will work directly with subject matter experts to ensure content accuracy, improve efficiency and documentation practices.

Job Responsibilities

Heavy documentation, revising and creating SOPs, writing and formatting standard operating procedures and batch records, good comms, word skills, some GMP background and process development – this is budgeted to September, but there is always a chance it can be extended. How documents fit into vision of overall scheme, might be quality control or assurance documents, communicate with groups on their needs, meeting deadlines is critical, ask the right questions when you don”t understand

• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Conducts document revisions and/or document management
• Utilizes manufacturing process knowledge and documentation skills to identify areas of improvement or gaps within documentation and resolve issues and drive continuous improvement
• Participates in cross functional teams to drive completion of document revisions or creation with a focus on prioritization and timelines for completion
• Participates in cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
• Works independently with minimal supervision and direction
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
• Creates and presents trending and metrics reports

Education & Qualifications

• Years of experience range from 2-6 years, but someone more senior than that we can work with.
• Bachelor”s degree in Engineering or Life Sciences is preferred
• High school diploma/GED or Biotech Certification with 2-4 years of experience, or Bachelor”s Degree with 1-2 years of experience in biopharmaceutical operations
• Understanding of biologics drug substance operations or a similar complex specialized environment
• An understanding of regulatory requirements and their applications in a cGMP environment
• Experience with electronic documentation systems for controlled documents in a cGMP environment
• Excellent written and oral English language skills
• Strong skills in the use of Microsoft Word including formatting Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
• Ability to manage multiple competing priorities in a fast-paced environment
• Understanding of lean manufacturing methodologies and operational excellence

Benefits

• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance

Chat with me now! – https://flashrecruit.com/jobs/298781

– Develops a thorough understanding of the audience and the documentation required by meeting with colleagues, and working with managers to discuss technical problems

– Researches and builds knowledge about risks, controls, services, technology, or concepts to be documented

– Plan, develop, organize, write and edit cybersecurity policy statements, technical standards, training manuals and control/operational procedures

– Produce electronic documentation in addition to hard copies

– Maintains a comprehensive library of technical terminology and documentation

– Analyzes documents to maintain continuity of style of content

– Develops standardized templates that can be used throughout the organization

– Manages updates and revisions to technical documents

– Provide technical writing support across the Cybersecurity organization and programs

– Coordinates and leads multiple concurrent technical writing activities through coordination with internal stakeholders

– Develops a technical writing plan and roadmap to prioritize all documentation needs across the organization

– Determines the clearest and most logical way to present information and instructions for greatest reader comprehension and writes and edits technical information accordingly

– Prepares or commissions graphics and illustrations to elaborate on or complement technical writing

– Meets with subject matter experts in order to validate that specialized topics are appropriately addressed and discussed

– Creates, adapts, and follows project schedules and deadlines

An American multinational corporation specializing in Internet-related services and products is currently seeking a Technical Writer in the Addison, TX area. This is a 1-year CONTRACT position. No per diem available.

Responsibilities for the Technical Writer

• Write product and process procedures, develop installation and commissioning guides as well as training modules.
• Develop complex, technical documentation for internal and external audiences and may manage projects that involve coordinating multiple junior writers.
• Document new processes being introduced to our field teams. Develop training modules for accelerated network turnup and NetOps 2.0 initiatives.

Requirements for the Technical Writer

• Bachelor”s degree with 3 years of relevant experience developing documentation for router and optical transport devices (or similar telecom technologies).

Benefits

• 401K
• Health Insurance

Heavy Truck Dealership – Service Writer – Lima, Ohio

Whiteford Kenworth, a division of Lower Great Lakes Kenworth, Inc., has 1 immediate opening in Lima, OH for a Service Writer 1st Shift, 7:30 am – 3:30 pm Monday – Friday.  The candidate selected for this position is self-motivated and a successful customer service professional.  The Service Writer duties will include direct engagement with customers, Diesel Technicians and other Lima departments.

Job description:

• Greets Customers at Service Counter and answers phones
• Generates repair orders
• Writes job estimates
• Assigns and schedules jobs to technicians
• Generates billing statement for service and/or parts customers
• Pulls parts from inventory supply for Diesel Technicians when needed

Abilities and Skills

• High level customer service skills
• Above average computer and internet based system skills
• Knowledge of heavy duty truck operating systems
• Ability to clearly communicate verbally and in writing with customers, employees and management for service and parts

Benefits Include:

• Competitive Salary
• Medical & Dental Insurance
• Life Insurance
• Personal Time Off program
• 401k with employer Match
• OEM Continued Education
• Extensive Training and Engine Certification
• Uniforms
• Latest Diagnostic Tools and Equipment
• Internal Promotion Opportunities
• On the Job Training

Role: Technical Writer

Location: NYC

Duration: 6+ Month

This role is an opportunity to work in a fast paced startup like culture along with a highly focused security team. This role will be a blended role of business analysts, discovering and defining technical components and process along with a technical writer where the findings will be crafted into a externally presentable documentation. The primary audience of this documentation will be a technically savvy regulatory entity who wants to understand intimate details of the architecture.

Key Qualification:

• Experience working as a senior technical writer
• Completed past projects for regulatory entities SOX, PCI, etc (FEDRAMP is preferred)
• Experience writing and successfully delivering a System Security Plan (SSP)
• Have reported to senior leadership VP / CTO / CIO / etc