URGENT HIRE Technical Writer

Company: Aerotek
Location: Rockville
Posted on: April 9, 2021

Job Description:

Description:Individual will ensure deviations/CAPAs/CCs are timely addressed and closed relating to manufacturing/technical operations/quality control for the Fill and Finish Facility. Work closely with department subject matter experts (SMEs) to obtain pertinent information necessary to write/close deviations, providing expertise on necessary preventive measures, and to ensure site deviation metrics are in a controlled state. Individual will be the SME for defending relevant deviations in GMP audits (internal and external). Individual will lead and coordinate efforts for continuous improvement in deviation reduction and manufacturing operations for the site. - Deviations - investigate deviations from all departments, perform thorough product impact analysis, utilize root cause analysis tools and work cross functionally to implement effective CAPAs. Interview personnel involved to determine true root cause, work closely with QA to close deviations prior to deadlines, organize and manage investigational team meetings. Communicate across multiple groups and levels to obtain consensus to facilitate deviation closure and CAPA implementation.- CAPA/CC- Write CAPAs & CCs to meet production release requirements, support continuous improvement efforts and operational optimization. Identify appropriate CAPA/CC implementation plan and/or effectiveness checks.- Additional Documents - write, review, revise and/or prepare manufacturing documents (BPRs, RPTs, SOPs, SWIs, etc.) in accordance with cGMPs and regulatory guidelinesSkills:corrective action plans, quality assurance, GMP, SOPTop Skills Details:Technical WritingDeviation WritingQuality InvestigationAdditional Skills & Qualifications:Bachelor's Degree in Science and/or related fieldMinimum of 2-5 years of technical writing experience in the pharmaceutical/biotechnology discipline.Experience Level:Entry Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Rockville , URGENT HIRE Technical Writer, IT / Software / Systems , Rockville, Maryland