Technical Writer

• Responsible for writing clear accurate and compliant protocols and reports for the transfer of analytical test methods.
  
• Collaborate with subject matter experts (SMEs) and cross functional teams to gather and verify technical information ensuring the accuracy and completeness of documentation.
  
• Create and update test specification documents for raw materials and finished products.
  
• Assist in drafting analytical procedures.
  
• Review and manage technical documents for approval in the electronic document management system (eDMS).
  
• Prepare and design comparative studies and development studies for analytical testing.
  
• Identify opportunities for process improvements and contribute to the development and maintenance of documentation best practices.
  
• Support various project activities in the analytical lab as needed ensuring readiness for testing or studies.
  
• Stay uptodate with industry regulations and guidelines (e.g. FDA EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.
  
• Additional requirements as assigned.
  

Requirements

• 3 years of technical writing and documentation experience in a cGMP environment.
  
• Excellent technical writing and documentation skills.
  
• Experience with analytical procedures and test methods.
  
• Strong knowledge of cGMP regulations.
  
• Proficiency with electronic document management systems.
  
• Excellent communication skills both verbal and written with the ability to convey complex technical information in a clear and concise manner.
  
• Attention to detail and a commitment to producing errorfree documentation.
  
• Highly motivated with the ability to work independently manage multiple projects and meet deadlines.
  
• At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
  

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
  
• PTO Sick Time and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more).
  
• Financial Perks and Discounts