SOP Specialist / Technical Writer (Training & Documentation)-Medical Devices

Intellectt INC

Rensselaer, NY

JOB DETAILS
LOCATION
Rensselaer, NY
POSTED
7 days ago

Job Title: SOP Specialist / Technical Writer (Training & Documentation)

Location: Rensselaer, NY

Employment Type: Contract (W2)

Duration: 6 Months (Possible Extension)

Salary/Rate: $40/hr on W2

Experience Required: Minimum 5 Years

About the Role:

We are seeking a detail-oriented SOP Specialist / Technical Writer to support a critical project focused on documentation development, training alignment, and process standardization. This role involves creating, reviewing, and editing SOPs and Work Instructions while ensuring compliance with regulatory standards and delivering clear, training-friendly content.

Key Responsibilities:
  • Develop, review, and edit SOPs and Work Instructions to ensure accuracy, consistency, and compliance with FDA, ISO, and cGMP standards

  • Collaborate with SMEs and cross-functional teams to gather process information and translate into clear documentation

  • Partner with e-learning specialists to storyboard and structure training content

  • Ensure documentation is user-friendly, concise, and suitable for training purposes

  • Maintain document control standards, including versioning and formatting consistency

  • Identify documentation gaps and drive improvements for clarity and usability

  • Support audit readiness by ensuring all documentation meets compliance requirements

Required Qualifications:
  • Bachelor's degree in Life Sciences, Engineering, Technical Writing, or related field

  • 3+ years of experience in SOP writing, technical documentation, or quality documentation in pharma/medical device industries

  • Strong understanding of cGMP, FDA, and/or ISO regulations

  • Experience with document management systems

  • Excellent writing, editing, and communication skills with strong attention to detail

Preferred Qualifications:
  • Experience working with training teams or e-learning developers

  • Familiarity with instructional design or training content development

  • Prior experience supporting audits or compliance-driven projects

Equal Opportunity Employer:

We are an Equal Opportunity Employer and value diversity at all levels. All qualified applicants will receive consideration for employment without regard to race, religion, gender, sexual orientation, national origin, disability, or veteran status.

Background Check:

Employment may be contingent upon successful completion of a background check and verification of employment history.

Work Authorization:

Candidates must be authorized to work in the U.S. without sponsorship

About the Company

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Intellectt INC