Technical Writer I-Senior

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

The Technical Writer (I, II, III and Senior), provides Manufacturing support Manufacturing operations by planning, collaborating, and implementing timelines to generate and maintain GMP documents related to GMP operations while ensuring compliance with established processes and standards.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES I/II

• Write and revise GMP documentation including but not limited to: Standard Operating Procedures (SOPs), Work Instructions (WOIs), and Manufacturing Production Records (MPRs).
• Facilitate cross functional and collaborative discussion regarding technical writing tasks, for the Manufacturing Department.
• Ensure collaboration among applicable departments (e.g. Manufacturing, Quality Control, MSAT, etc.), as it applies to technical writing.
• Maintain Good Documentation Practices (GDP) including company error prevention practices for document management.
• Communicate statuses, risks, and timelines effectively to management.
• Follow and adhere to company policies and procedures.
• Maintain templates, trackers, and metrics for documents and projects.
• Develop a strong understanding of the manufacturing process and product.
• Maintain on time training qualification in accordance with company policies.
• Act as a technical writing representative between departments and for client interactions
• Maintain safe work environment.
   

ESSENTIAL JOB DUTIES & RESPONSIBILITIES III/Senior

• All essential job duties applicable to the Technical Writer I/II, Manufacturing position.
• Facilitate cross functional and client facing discussions regarding general technical writing tasks as well as critical process updates, as applicable.
• Participate in technical client facing meetings and communicate outcomes to prioritize project changes and drive strategic implementation.
• Manage complex projects or improvement initiatives, as it relates to manufacturing technical writing, including but not limited to training, new employee onboarding, tracking tools, etc.

TECHNICAL KNOWLEDGE & LEADERSHIP SKILLS

• Ability to apply GMP requirements as they relate to manufacturing operations and quality management systems
• Demonstrate experience with technical writing and GMP documentation
• Experience with managing  and progressing multiple priorities
• Ability to work interdepartmentally effectively with good interpersonal skills
• Strong technical writing and communication skills
• Strong computer literacy required (e.g. MS Office Suite, etc.)
   

EDUCATION & EXPERIENCE

• BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline preferred.
• Experience using quality management systems software (e.g. TrackWise) preferred.

• Equivalent education and experience may substitute for stated requirements.
• Levels have different requirements – these are listed as follows:
   

Technical Writer I – Manufacturing

• 0 to 2 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
   

Technical Writer II – Manufacturing

• Minimum 1 to 4 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
   

Technical Writer III – Manufacturing

• Minimum of 5 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
   

Technical Writer, Senior – Manufacturing

• Minimum of 8 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.

COMPENSATION RANGE
$25.65 - $49.55, depending on level and experience

 

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufactu