Technical Writer (Remote)
Posting ID: JP-002663509
• Edit and write pharmaceutical manufacturing batch records, protocols, reports, SOP’s, and other supporting documents.
• Collaborates with area SMEs or technical specialist to create or revise existing procedures or documents for use in the manufacturing processes.
• Interact with Drug Substance, Drug Product and QA departments to support and/or write SOPs, Work instructions and MBRs that are accurate and usable.
• Analyze documents and documents sets to identify opportunities for improvement.
• Manage multiple priorities.
70% of this candidates time will be writing and formatting documents in Microsoft Word, very documentation heavy
30% of the time will be spent attending meetings, reflecting statuses for biometric they are managing, connecting with others, working with other departments to pull specific information from SMEs necessary for document creation.
SOP, SOP Writing, GMP, Writing procedures, microsoft word, manufacturing process, Technical writing, Technical documentation
Top Skills Details:
SOP,SOP Writing,GMP,Writing procedures,microsoft word,manufacturing process,Technical writing,Technical documentation
Additional Skills & Qualifications:
• Bachelor of Science or Associates degree - preferably in a life science or pharmacy
• Basic understanding of pharmaceutical drug substance and/or drug product manufacturing operations.
• Excellent verbal and proven written communication skills
• Require strong fluency in MS Office.
• Able to work both independently and collaboratively with little supervision
• Strong interpersonal and communications skills; written and oral.
• Experience writing and revising SOPs, Master Batch Records, Work Instructions, and/or OJTs for a biopharmaceutical GMP Manufacturing process.
• Experience in pharmaceutical manufacturing operations with a strong knowledge of technical manufacturing systems.
• Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in diverse areas.
• Must be skilled in meetings and interviews to eliciting technical details from subject matter experts.
• Must be able to provide effective written or verbal communication to peers and area management within their operational group.
• Must be able to develop logical structure for technical documents, content, and illustrations
• Must be detail oriented while proofreading documents.
• Must be able to understand operational documents for GMP compliance, accuracy, and completeness.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072