Position: Scientific Writer

Location: Fremont, CA

Duration: 12 Months

Job Type: Contract

Work Type: On Site

Pay Rate: $35 to $38/hr

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.

Position Summary:

• The Technical Writer II is responsible for supporting the Quality Assurance and Regulatory Affairs teams by creating, revising, and maintaining documentation related to IVDR submissions.
• This role works cross-functionally with Manufacturing, Operations, and Project Management teams to address documentation gaps, revise documents, submit ECOs, and maintain project timelines to meet regulatory compliance requirements.

Job Responsibilities

• Work cross-functionally with other teams to create or revise documentation via the established document control process.
• Review and recommend revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions.
• Work closely with Quality Assurance to ensure documentation implemented is compliant with regulatory requirements.
• Maintain strict compliance with Quality Management System requirements, ISO 13485, cGMP, QSR, and other applicable regulations and/or standards.
• May be called upon the implement procedural changes supporting continuous improvement initiatives.
• Respond to Quality action related to CAPAs, SCARs, or nonconformances.
• Proof-read and provide feedback on documentation prepared by other departments.
• Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage many technical documents simultaneously.
• Ability to work independently and collaborate with cross-functional teams to identify appropriate content updates as required.
• Participate in cross-functional documentation projects as required.
• Keep functional leadership and/or project management appraised project status.
• Additional tasks as assigned.

Ideal Candidate Preferred Qualifications

• Effective communication skills and the ability to collaborate with cross-functional teams
• Education: B.S./B.A. in a scientific discipline (e.g. chemistry, chemical engineering, biology, bioengineering, etc.).
• Preference is given to candidates with technical writing and scientific background.
• 2 to 5 years of experience in a regulated environment (ISO 13485, FDA QSRs, GMP, or IVDs)
• Ability to work independently with guidance from leadership, and as part of a team;
• Manage multiple activities, and adjust to changing priorities in a dynamic, FDA-regulated environment.
• Strong attention to detail, and ability to understand technical terminology and complex processes.
• Experience in using an electronic Document Management System as a Technical Writer.
• Must be computer literate and competent in PC-based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
• Must be organized and detail-oriented to be able to prioritize own and other’s work and meet business productivity metrics.
• Proofreading and editing skills, and an aptitude for numbers and detail-oriented work requiring a high degree of accuracy.
• Must have excellent customer service and listening skills.
• Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.
• Able to sit, stand, and/or use the keyboard for long periods.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.