Professional Technical Writing US

Provide direction and/or directly write, review, revise and prepare manufacturing documents (BFR, SOP, SWI, Protocols, etc.) as detailed as necessary for clear understanding of each step by one experienced in the manufacturing of products in accordance with cGMP and CBER regulations. ON line supervisor over hourly employees engaged in the manufacturing of products in accordance with cGMP, CBER regulations and in keeping with sanofi pasteur objective of good employee training on an as needed basis. Provides oversight of the department’s revisions, enforcement of individual qualification requirements, and program improvements. Conducts counseling, coaching, and development planning for all department Document Coordinators and Training Coordinators. Formalizes internal procedures for document generation, document revision, batch record preparation, document archiving, and incident investigation support. Facilitate/coordinate execution of validation activities in support of members. Develop, revise, communicate department metrics regarding safety, quality, productivity. Identification and facilitation of interdepartmental process improvements which may include change control, investigation writing/review, CAPA implementation, and operational optimization.We are an equal opportunity employer M/F/D/V
REQUIREMENTS
BS degree in Biological Science, Engineering or equivalent with relevant experience in manufacturing and/or filling of biological products. 1-2 years of experience in manufacturing and or development departments. Must have previous experience in working with a production department of a pharmaceutical company. Working knowledge or cGMP’s. must have knowledge of continuous improvement techniques and problem solving skills. Excellent verbal and written communication skills. Working knowledge of SAP is preferred. Candidate must be able to work overtime and flexible hours, including weekends.