Batch Record Writer

Responsibilities

• Creates manufacturing Batch record templates for multi-product.
• Writes, and edits technical documents related to bio-manufacturing by working seamlessly with cross functional teams under general supervision.
• Has advanced Microsoft Word skills and balances accuracy with speed under pressure, creating efficient documents while remaining compliant with the regulatory requirements.
• Sets priorities to ensure documents are ready when needed per the production schedule.
• Creates or revises and manages the workflow for MFG documents
• Checks out the document
• Determines reviewers/ approvers based upon the changes requested and the document type
• Obtains technical content from Subject Matter Experts (SMEs) and drafts new / revises existing documents using current templates
• Follows up with the reviewers/ approvers and address comments
• Coordinates the document workflow in documentation management system (IDEA for CON)
• Drives consistency within the document, between documents, such as:
  • Significant figures
  • Formatting (date/time consistency, documentation consistency, etc.)
  • Chunk information so that it is easily digestible
  • Spacing consistency in the document (ensure there is enough space to attach attachments and to write content)
  • Step number references
• Batch record flow should be consistent across different products and learnings from a particular campaign should be carried forward to the next set of batch records.
• Facilitates meetings to resolve / address comments (if the document revision is extensive), and to reach consensus with multiple stakeholders.

Experience

• High School Degree + minimum 2 years of work experience in GMP regulated industry
• Associates/Bachelor's Degree or Biotechnology vocational training preferred.
• 2 or more years of experience in cGMP regulated industry.
• Quick learner, understanding of presented technical/scientific content.
• Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
• Able to adapt to changing needs caused by time, budget, or other constraints.
• Must be highly collaborative; have the ability to work within a diverse team.
• Bio-manufacturing floor operations, training, validation, quality assurance experience in a bio-pharmaceutical industry
• Knowledge of Biologics with bio-manufacturing and documentation management system processes experience.
• Advanced proficiency in MS Word and intermediate proficiency in MS Visio.
• Technical writing experience of 1 year with a certificate in Technical writing is highly desirable.

Shift: 1st