Technical Writer

We are looking for a Technical Writer for a 6 month contract role located in San Rafael, CA.

Responsibilities

The Technical Writer position will support Manufacturing in the creation and/or revision of Procedures (SOP’s), Batch Records (BR’s), and Electronic Batch Records (EBR’s) pertaining to Upstream, Downstream, and/or Solution preparation process operations. This will include working with Manufacturing Subject Matter Experts to ensure document accuracy and detail.

• Initiation and management of document workflows to ensure adherence to deadlines and coordinating document changes for identified Corrective and Preventive Actions.
• Ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
• Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
• Build and maintain Client’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
• Write and revise cGMP documentation (Standard Operating Procedures, Production Batch Records and/or Electronic Batch Records) and facilitate the review and approval of documents in a timely manner and within established timelines.
• Ensure documents are technically accurate and consistent with internal style guidelines for format, clarity, flow, organization, and readability.
• Manage work independently to ensure timely implementation of documentation workflows.
• Work with Manufacturing Management and QA Change Control to establish comprehensive implementation plans for document revisions and associated change requests.
• Interact with appropriate departments to establish priorities and deadlines for document revisions.
• Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintained.
  
  

Qualifications

• Bachelors Degree, preferably in the Life Sciences or Engineering field
• Technical writing experience including manufacturing procedures and instructions
• Minimum of 2+ years industry experience in a cGMP environment
• Authoring and reviewing documents and working with business partners (other departments and QA), vendors, and SMEs on content.
• Excellent written and oral communication skills, ability to work in a fast-paced team oriented environment.
  
  

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.