Biotech and Pharmaceutical, Budgeting, Campaigns, Cross-Functional, Current Good Manufacturing Practice (cGMP), Document Management, GMP (Good Manufacturing Practices), High School Diploma, Manufacturing, Manufacturing Management, Manufacturing Operations, Microsoft Visio, Microsoft Word, Quality Assurance, Regulatory Requirements, Team Player, Technical Editing, Technical Presentation, Technical Writing, Time Management, Writing Skills
Fremont, CA
Contract Duration: 6-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities:
- Excellent employment opportunity for a Batch Record Writer in the Fremont, CA area.
- 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