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WE ARE HIRING - NEW OPPORTUNITIES!: Contract Technical Writers - Many Openings

Bulletproof Documentation, Inc.

Location:
Burlingame, CA
Posted Date:
12/14/2014
Position Type:
Consultant, Contract, Full time
Job Code:
3
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Cell Culture, Manufacturing/Production, Pharmaceutical, Professional Services, Purification, QA, QC, Quality Assurance, Quality Control, Writer,

Job Description

WE ARE HIRING!  SEVERAL NEW OPPORTUNITIES!

Seeking contract technical writers for multiple projects:

- Biologics Manufacturing Batch Records and SOPs
- Market Authorization Transfer
- Technical Transfers
- Biologics Deviations and Investigations
- Annual Product Reviews
- Diagnostics Instrumentation User Documentation

Contract position providing technical writing support for GMP manufacturing and quality documentation.  

Job responsibilities include:

• Create (from-scratch) and/or significantly rewrite documents may include batch  records, SOPs, data forms, specifications, and logsheets.
• Master technical information, organize content, and imbed GMP compliance.
• Align documents within and across one another to prevent gaps, overlaps, and contradictions or conflicting instruction.
• Work independently, with minimal SME input, to draft documents and redlines.
• Meet deadlines.
• Contribute to training materials as required.
• Manage document review cycles, including solicitation of feedback, comment remediation, issue escalation and/or resolution, and finalization in copy-ready format.
• Schedule, lead, and facilitate document review meetings.
• Participate on project teams as needed.
• Expeditiously and accurately process large volumes of documents, with short turnaround and high quality and accuracy.
• Understand how GMP documents fit together and can independently manage document dependencies.

Requirements

• BS/BA and at least 8 years pharmaceutical industry experience, 5+ years in technical writing role preferred.
• Experience with consent decree, quality remediation in the small molecule and biologics areas big plus for more senior opportunities.
• Impeccable attention to detail.
• Ability to manage shifting priorities and fast pace.
• Strong written and verbal communication skills.  
• Fast and agile in MS Word, Excel, and Visio
• Comfortable leading and influencing without authority.
• Comfortable holding project team members and senior management accountable to support documentation objectives.  
• Ideal candidate has hands-on manufacturing, engineering, QC and/or QA experience (depending on role) and can speak intelligently on documentation related issues.
• Travel may be required, depending on project.


Check out additional project openings at:  www.bulletproofdocs.com/opportunities

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