Proclinical is currently recruiting for a Technical Writer with a pharmaceutical company located in Philadelphia, PA. The Scientific Technical Writer is responsible for the preparation and implementation of documents, protocols, test methods, analytical transfer plans, risk assessments, reports, procedures, equipment change controls, training materials and other documents as required to support Laboratory Operations. The Technical writer must be able to organize, understand and present complex scientific and technical information
at a level that is appropriate for people with technical and nontechnical backgrounds. The position requires effective planning, scheduling, researching, and writing skills and is recognized as subject matter expert in a scientific discipline.
- Authors technical documents (create, write and review), in support of Molecular Biology
- Relay complex technical processes and procedures in a clear and concise written format that is easy to understand.
- Review current documentation for organization, content, technical accuracy, and style. Keep informed of laboratory activities to determine the need for revisions, corrections, and changes in documents
- Knowledge of Molecular Biology scientific techniques and processes
- Create user requirements specifications (URS) for equipment and instruments and complete change control documentation.
- Demonstrate critical thinking and logical reasoning skills, attention to details, ability to manage multiple deadline-oriented tasks, excellent communication and editing skills.
- Work with our cross-functional teams as necessary to support the various phases of new document preparation and execution
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.
- Highly organized with the ability to juggle multiple priorities and deadlines at once.
- Thorough understanding of Good Manufacturing Practices
- Other duties as assigned by management
Skills and Requirements:
- Experience preparing Molecular Biology test methods and/or test protocols is required.
- Bachelor's degree with major in Biological Sciences or other science-related major and 5 years of laboratory and root cause analysis experience related to quality control non-conformances.
- Master's degree with major in Biological Sciences or other science-related major and 2 years of laboratory and root cause analysis experience related to quality control non-conformances.
- Doctorate degree with major in Biological Sciences or other science-related major and 0-1+ years of relevant experience.
- Experience in an FDA regulated laboratory and prior knowledge of Master Control system is a plus.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.