TECHNICAL WRITER II

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

• Title: TECHNICAL WRITER II

• Location: Houston, TX

• Industry: Pharmaceutical

• Hours: Mon - Fri 8am - 5pm

• Salary: $38hr based on experience

• Employment Type: Long Term Contract

Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.

Job Summary:
The Technical Writer is responsible for writing and revising cGMP documents and act as a primary point of contact and adviser with regards to the creation of new production documents for Cell and Gene Therapy processes during a Technology Transfer.

Key responsibilities:

• Write and revise manufacturing documents, including but not limited to Master Batch Records, Quality Control Sheets, product labels, Material Specifications, and Standard Operating Procedures.
• Serve as primary advisor for documentation.
• Implement EPS (Error Prevention System) to batch record templates.
• Collaborate with other departments to develop user-friendly templates.
• Offer suggestions on improving document format to make documents more usable to the target audience.
• Conduct training on new and revised SOPs and as required due to manufacturing document format changes.
• Provide assistance and advice to internal customers on the use of the Electronic Document Management System.
• Other document projects as assigned by the department manager.
• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

Perform other duties as assigned.

Work Experience:

• Cell culture, molecular biology or biotech/biopharma laboratory and/or manufacturing experience, preferably in a cGMP-manufacturing environment
• Technical writing including manufacturing documentation and Standard Operating Procedures
• GMP compliance knowledge; direct knowledge of relevant documentation requirements for cooperative
  manufacturing
• Part 11 compliance knowledge
• Computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management
• Excellent Written and oral communication skills; listening skills; independent and self-directed

Education:
Bachelors - Biology, life sciences, engineering or related

EOE/ADA