Collabera
Collabera is hiring: Technical Writing / Documentation Specialist...
Collabera - West Point, PA, United States, 19486
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Overview
Description
Technical Writing / Documentation Specialist
Contract: West Point , Pennsylvania, US
Salary Range: 30.00 - 35.00 | Per Hour
Job Code: 359386
End Date: 2025-03-29
Days Left: 24 days, 2 hours left
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About the Role:
We are seeking a Release and Critical Documentation Specialist to join our team. The ideal candidate will be responsible for generating, reviewing, and maintaining documentation related to the submission, testing, and release of raw materials, culture media/buffers, and excipients. This role requires strong technical writing skills, experience with Good Manufacturing Practices (GMP), and the ability to manage multiple projects while meeting deadlines.
Key Responsibilities:
Job Requirement
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- Job Description
Technical Writing / Documentation Specialist
Contract: West Point , Pennsylvania, US
Salary Range: 30.00 - 35.00 | Per Hour
Job Code: 359386
End Date: 2025-03-29
Days Left: 24 days, 2 hours left
Apply
About the Role:
We are seeking a Release and Critical Documentation Specialist to join our team. The ideal candidate will be responsible for generating, reviewing, and maintaining documentation related to the submission, testing, and release of raw materials, culture media/buffers, and excipients. This role requires strong technical writing skills, experience with Good Manufacturing Practices (GMP), and the ability to manage multiple projects while meeting deadlines.
Key Responsibilities:
- Develop and maintain release protocols and critical GMP documentation.
- Oversee and coordinate the review and approval process for Standard Operating Procedures (SOPs).
- Manage administrative functions within the Learning Management System (LMS).
- Collaborate with Subject Matter Experts (SMEs) to develop training requirements for SOPs and other essential materials.
- Utilize standardized templates for SOPs and supporting documents.
- Education: Bachelor of Science (B.S.) degree or equivalent in a related field.
- Experience: Minimum of 4 years of relevant experience.
- Strong technical writing skills with a focus on compliance documentation.
- In-depth knowledge of Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP).
- Ability to manage multiple projects and meet critical deadlines.
- Strong organizational, interpersonal, and communication skills.
- Working knowledge of regulatory requirements and guidelines (CFR, ICH).
- Experience with Documentum and SOP management is preferred.
- Pay Range: $30 - $35 per hour
Job Requirement
- Technical Writing
- Pharma
- Pharmaceutical
- GMP documentation
- GMP
- cGMP
- SOPs
- LMS
- Critical Documentation
- Batch records
- Recruiter
- Phone
- Rohan Lazarus
- rohan.lazarus@collabera.com
Apply Now