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Pyramid Pharma Services provided pay range

This range is provided by Pyramid Pharma Services. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70,000.00/yr - $90,000.00/yr

Direct message the job poster from Pyramid Pharma Services

Reporting to the Executive Director of Manufacturing & Supply Chain, the Technical Writer is responsible for creating, editing, and maintaining high-quality technical documents that adhere to GMP regulations. This includes Standard Operating Procedures (SOPs), batch records, validation protocols, deviations, change controls and training materials.

About the Role

The Technical Writer plays a crucial role in ensuring that all technical documentation is accurate, compliant, and up to date, contributing to the overall quality and efficiency of the manufacturing and supply chain processes.

Responsibilities

• Author, format, and update various technical documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and assist with Engineering Protocols (e.g., Installation Qualifications, Operational Qualifications).
• Perform thorough investigations of manufacturing, supply chain, visual inspection and packaging non-conforming events that could include review of cGMP documents and historical review of the quality management system.
• Perform investigations using structured root cause analysis tools (fishbone, 5 Why’s, etc.) and partner with team members across operations (manufacturing, supply chain, quality, engineering) to determine “true” root cause.
• Conduct personnel interviews of those individuals involved with events.
• Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components.
• Collaborate with Subject Matter Experts (SMEs) and cross functional teams to gather and verify technical information, ensuring the accuracy and completeness of documentation.
• Review and edit existing documentation for clarity, accuracy, and compliance with industry regulations.
• Assist in the development of training materials and conduct training sessions for staff on documentation practices.
• Ensure all documentation is properly version-controlled and archived according to regulatory requirements.
• Participate in audits and inspections, providing documentation as needed to demonstrate compliance.
• Stay up to date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.
• Additional responsibilities as needed.

Qualifications

• 4+ years of Experience
• Bachelor’s degree in communications, professional writing, English, biological/ medical/ engineering sciences, or equivalent preferred.

Required Skills

• Strong writing and editing skills.
• Knowledge of GMP regulations and industry standards.
• Experience with technical documentation.
• Ability to work collaboratively in a team environment.

Preferred Skills

• Experience in the manufacturing or supply chain industry.
• Familiarity with regulatory submissions.

Pay range and compensation package

Compensation details will be discussed during the interview process.

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Writing/Editing and Administrative

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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