Technical Writer / Pharmaceutical

Company: Yoh Engineering Location: Philadelphia, PA 19403 Status: Full Time, Temporary/Contract/Project Job Category: Biotech/R&D/Science Relevant Work Experience: 1+ to 2 Years Career Level: Entry Level Education Level: Bachelor's Degree  We've been delivering the best talent to America's leading companies for the past 7 decades - longer than any of our competitors. These customers count on our experience, time-honored processes, responsiveness and market intelligence to build their businesses. Most importantly, they look to Yoh to deliver talent with fresh ideas and empowered minds who want to fulfill their potential. People like you. Life's short. Live your dream. Tell us where you want to work. What you want to do. And we'll help get you there. Basic Qualifications (entry level) BS in Engineering or Life Sciences, preferred Prior experience in the validation, analytical methods or project engineer, preferred Training Provided GMP GDP Electronic Experiment LIMS PIER eDM 7i Validation SOPs Others, as needed This individual will: Obtain, track and organize data from various company data repositories/ systems for inclusion in product portfolio binders, reports, protocols and other various mediums for presentation in support of company activities (inspections, audits, filings and other) Be responsible for maintaining GMP document/ binder integrity/ DC integrity and Equipment File Room integrity Support documentation requirements (copying, filing, binding, etc…) and actions (runner) as needed for inspections, audits, filings and other Interface with various departments inside/ outside of BpC to obtain reports, protocols, methods, memos, notebooks, batch records and other forms of GMP documentation that will support filing of biopharms. Assemble timelines for product development activities (VISIO OJT) Manage knowledge transfer information Serve as focal point for specific project aspects involving filing of biopharms Assemble evidence packets for various GMP aspects associated with audits, inspections Pending relevant experience, the individual will: Participate in writing, scheduling and executing validation protocols, gathering and analyzing data, and writing final validation reports in accordance with cGMPs and company Policies. Participate in development of requirements and specifications in support of GMP Operations Play a key role in determining the level of validation required to be in compliance with regulatory requirements. Interface with staff in Operations, Technical Services, Automation Engineering, Quality Control and Quality Assurance  to coordinate resources and complete validation activities in a timely manner. Manage and/or perform validation activities associated with change controls and the validation maintenance program.  Ensure that the change controls associated with Validation activities are addressed in a timely fashion. Review/Approve SOP's, change controls, investigations and deviations as required. Partnering with Yoh In addition to great career opportunities, consulting with Yoh comes with its perks: Competitive compensation plans Wide variety of benefit options Yoh Advantage - our consultant rewards program that offers discounts and perks at leading companies and with national brands exclusively for Yoh Yoh is one of the largest providers of talent and outsourcing services to customers in the United States. With over 374 million USD in total sales, Yoh operates from more than 75 locations and provides long- and short-term temporary and direct placement of technology and professional personnel, as well as managed staffing services, for the information technology, scientific, engineering, health care and telecommunications communities. For more information, visit yoh.com. Yoh is part of Yoh Services LLC, a Day & Zimmermann Company.