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Associate Technical Writer, Biopharma GMP – Remote(JP9423)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Associate Technical Writer, Biopharma GMP – Remote(JP9423)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: GSC OPS Improvement (Make/Deliver)
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Posting Date: 11/12/2021


3 Key Consulting is hiring an Associate Technical Writer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
  • 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.).
  • Responsibilities include:
    • 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.
  • Authority
    • Ability to apply risk-based approach, making decisions and escalating issues appropriately
  • 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

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
  • 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

Day to Day Responsibilities:
  • Managing Change control records, deviations and CAA records.
  • Creating and maintaining metrics and management reviews of quality system on a periodic bases.
  • Providing support in creating and maintaining Standard Operating Procedures (SOP), Business Practices etc.
  • Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.

Basic Qualifications:
  • MS Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills
  • 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 Qualifications:
  • Experience in audit / inspection support
  • Technical writing skills

Employee Value Proposition:
The person will work with supply chain global distribution. You will work with quality records and product theorization.

Interview process:
Video Skype Panel Interview


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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