Documentation Specialist II - California, United States - US Tech Solutions

Description

Job Description:

Searching for a highly motivated individual to fill the Documentation Specialist role in the Analytical Development Department.

The Analytical Development Department is responsible for analytical method development, method qualification and transfer to QC, and execution of analytical methods to provide product and process understanding, as well as analytical CMC program management.

Responsibilities:

Generate document templates for Analytical Development team.

Draft reports to support Regulatory filings including IND and BLA dossiers.

Develop and manage documentation procedures, including good documentation practices, handling and reviewing electronic laboratory notebooks, data and reports.

Develop and maintain document management systems.

Provide technical writing support for regulatory documents.

Collaborate with project leaders and subject matter experts (SMEs) to incorporate feedback into drafting and editing of technical reports.

Perform review and edits of the documents generated in Analytical Development.

Experience:

years of experience with technical publications in a regulated product development environment as a technical writer.

Experience with writing and reviewing technical documentation .

Experience with working in a GXP environment.

Knowledge and experience with HPLC, LC-MS, CE and icIEF methods for biologic products is a plus.

Knowledge and understanding of the development, commercialization, and life cycle management of biologic products.

Strong organizational skills.

Ability to establish relationships with other support areas to gather necessary information. Ability to work effectively in a team environment.

Attention to detail Ability to work cross-functionally Ability to organize work to meet deadlines.

Excellent interpersonal and oral/written communication skills, and advanced technical writing for submissions. Experience in regulatory filing and addressing health authority questions is a plus.

Skills:

Familiarity with MS Word, Excel, PowerPoint, Outlook and Adobe Acrobat.

Education:
To be considered a BS degree in chemistry, biochemistry or a related area is required; a doctorate level education is preferred.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.