Job Description

TECHNICAL WRITER provide technical support for clinical batch manufacturing which includes reviewing clinical batch production documents, QA evaluation, and support implementation of programs.

TECHNICAL WRITER RESPONSIBILITIES:

• Independently review, revise, and approve clinical batch production documents (master batch records, SOPs, change controls, deviations)
• Provide QA evaluation of discrepancies offering sound suggestions on improvement
• Train internal customers/stakeholders on QAD relevant activities
• Support internal and external inspections and audits
• Revises SOPs and other QA and compliance documents
• Signs Certificate of Conformance (CoC) and Certificate of Analysis (CoA)
• Review and approve manufacturing batch records, Sops, sample tables, and laboratory control records

TECHNICAL WRITER REQUIREMENTS:

• Bachelor’s degree in a scientific/technical discipline related to biology, biotechnology, chemistry or pharmaceutics
• 6+ years of related experience in the biopharmaceutical industry with an emphasis on Lot Release, Quality Assurance, Quality Control, Engineering or Manufacturing in a GMP industry
• Exposure to manufacturing records, testing reports and SOPs
• General understanding of drug development process
• Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines

Company Description

Every day at Hunter International, we connect clients with the best and brightest talent in their industry. We provide leading organizations nationwide with recruiting solutions that ensure an efficient and timely hiring process. In addition, we seek to understand job seekers’ skills and accomplishments, forging a career path that will enable them to reach their professional goals. Our process begins once you apply or upload your resume to work with our recruiting experts. If selected, you will receive a personalized review of your application as well as job recommendations to ensure you aren’t missing the right opportunity. Hunter’s expert recruiting team will advocate on your behalf with the hiring manager to communicate your unique qualifications and skills as the best choice for their job opening. We’ll handle gathering feedback from the hiring manager, coordinating your interviews and negotiating your pay. After a successful placement, our team will keep the lines of communication open throughout your journey. We’ll celebrate your success onsite, provide feedback and field questions because at Hunter we are #RootedinConnection Hunter International Recruiting is certified as a women’s business enterprise through the Women’s Business Enterprise National Council (WBENC), the nation’s largest third party certifier of businesses owned and operated by women in the US. We recognize the commitment to supplier diversity that is embraced by corporations and government agencies today, and we can add diversity to your supply chain. Follow us on Twitter: @hirecruiting Like us on Facebook: Hunter International Follow us on Instagram: @hunterinternational Connect With Us on LinkedIn: Hunter International Recruiting