Technical Writer
Lexington, MA
Job Type: Contract | Recruiter: Christie Spencer | Phone: 603.609.7082
Location: Greater Boston, MA (Onsite)
Length: 6 months
Job Description:
Our client is seeking an experienced Technical Writer for their growing team. This role focuses on reviewing, revising, and standardizing various Quality Control (QC), validation, and transfer methods and protocols to ensure compliance with Good Manufacturing Practices (GMP). The ideal candidate will have expertise in technical writing, strong knowledge of GMP regulations, and a background in validation and transfer protocols.
Essential Duties and Responsibilities (but not limited to):
- Review, analyze, and revise existing non-GMP methods to align with GMP regulations and compliance standards.
- Collaborate with internal teams and stakeholders to ensure accuracy, clarity, and alignment across procedures and documentation.
- Develop and write validation, QC, and transfer protocols that meet regulatory standards.
- Work with cross-functional teams to ensure cohesion between QC methods, validation methods, and company-wide quality systems.
- Minimum of 4 years of experience in technical writing, specifically for revising and drafting methods.
- Strong understanding of GxP (Good Practice) regulations.
- Proficiency with Empower software.
- Extensive knowledge of validation and transfer protocols.
- Familiarity with CE-SDS (Capillary Electrophoresis - Sodium Dodecyl Sulfate) and iCIEF (Capillary Isoelectric Focusing).
- Experience with Maurice instrumentation is highly desirable.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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