Job Summary
The Technical Writer is responsible for independently investigating and reporting on deviations to the process, customer complaints on finished product, and writing other documents as assigned.Responsibilities
- Initiate and implement change controls through the use of internal change control process
- Use Trackwise investigation system to open/investigate issues and implement corrective actions
- Initiate and implement cost improvement initiatives
- Implement required changes for new product introductions in support of tech transfer
- Review/audit master batch records to include running reports using Vantage Point/Dameware and entering data into Excel safe for annual product reviews
- Complete on-time department training Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.
- Maintains compliance with company policies, training requirements, cGMPs and safety standards.
- Perform other duties as assigned.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Requirements:
- Bachelor’s degree or equivalent experience.
- Requires advanced critical thinking and expert writing skills.
- One to two years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports is also required.
- Must be familiar with US FDA regulatory requirements.
- Good organizational, communication, and interpersonal skills are necessary.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Top Skills
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
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