Associate Technical Writer (Remote)

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Associate Technical Writer (Remote)

Contract: Thousand Oaks, California, US

Salary: $32.00 Per Hour

Job Code: 350382

End Date: 2024-07-06
Days Left: 22 days, 3 hours left

Apply

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL – email your updated resume at Email – View email address on click.appcast.io or give me a call at View phone number on click.appcast.io. Thank you!

Pay Range – $30 to $32/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

This is a very GMP compliance-driven role and environment. We need a candidate who will be able to read the SOP’s and follow them in a very detail oriented manner.

Job Details:

  • Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation.
  • When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
  • Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
  • Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process.
  • May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.);
  • Skills: ; MS Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills

Responsibilities:

  • Own and manage change control records
  • Own and manage minor and major deviation records and lead root cause analysis sessions
  • Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
  • Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
  • Incidental travel might be required.

Outputs

  • Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.

Competencies:

  • Effective communication skills at multiple levels, areas and countries
  • Ability to apply risk-based approach, making decisions and escalating issues appropriately
  • Analytical and evidence-based approach to problems.
  • Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.
  • Pro-active in proposing solutions and driving tasks to completion
  • Works autonomously, respecting deadlines
  • Works with a high degree of discipline and attention to detail

Qualifications:

Minimum Requirements

  • Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance
  • In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
  • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
  • Fluency in English , Dutch-preferable
  • Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc)
  • Preferred Requirements
  • Experience in audit / inspection support
  • Technical writing skills

Top 3 Must Have Skill Sets:

  • GMP experience
  • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
  • Experience in Technical writing, regulated environment experience (Food industry is acceptable); document version control experience.
  • Works autonomously, respecting deadlines
  • Works with a high degree of discipline and attention to detail

Job Requirement

  • Technical Writer
  • Quality Assurance
  • GMP
  • GDP
  • Supply Chain
  • CAPA
  • Quality
  • compliance
  • Quality Control
  • Biotechnology
  • Pharma
  • Pharmaceuticals

Reach Out to a Recruiter

To apply for this job please visit jooble.org.