Technical Writer

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.

We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.

• 
  Write, edit, and review cGMP manufacturing documents, specifications, methods, and engineering related material.
  
• Generate technical material in support of engineering documentation such as Process Flow Diagrams, Assembly Diagrams, and other drawings.
  
• Provide support in completing SOP changes as directed.
  
• Exercise judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision.
  
• Establish documentation practices that reduce review times and deviation by researching errors, finding inconsistencies in existing records, and communicating effectively with appropriate personnel.
  
• Edit documents written by others to verify accuracy, consistency, grammar, and format.
  
• Identify and support process improvement efforts (investigations/corrective actions).
  
• Maintain standardized language and documentation practices that allow for consistent execution of documents.
  
• Interact with appropriate departments to establish priorities and deadlines for technical documentation.
  
• Knowledge utilizing MS Office including Word, Visio, Excel and other electronic systems to complete tasks and documentation.
  
• Maintain compliance with company policies, training requirements, cGMPs and safety standards.
  
• Perform any other tasks/duties as assigned by Supervisor or Client.

Requirements

• Bachelors Degree, preferably in the Life Sciences or Engineering field
  
• Technical writing experience including manufacturing procedures and instructions
  
• 3-5 years industry experience in a cGMP environment preferred.
  
• Knowledgeable in P&ID, FDA GMPs (21 CFR, 210, 211, 820, and/or 600); ISO 9001 and 13485 a plus.
  
• Excellent written and oral communication skills, ability to work in a fast-paced team oriented environment.
  
• Experience in a biotech/pharmaceutical laboratory and/or manufacturing environment.
  
• Well organized and detail oriented; Ability to handle multiple projects.
  
• Willingness to learn detailed manufacturing processes.
  
• Intermediate to advanced knowledge of Microsoft Office software.

Benefits

• 
  Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at 24 Hour Fitness
  
• Financial Perks and Discounts