Quality Control Analyst (Tech Writer)

Company: Actalent
Location: Newark
Posted on: August 4, 2022

Job Description:

Description:The Technical Writer provides technical writing and supports authoring of quality system records such as laboratory investigations, deviations, CAPAs and change controls. Conduct investigations of laboratory investigations and deviations. Monitor completion of the quality events within Quality Control and provide escalation to management as needed. Perform metrics for laboratory investigations and laboratory operation parameters as appropriate. Author and/or revise other documents such as SOPs, methods, work instructions, protocols and reports.Skills:sop, writing skills, investigation and analysis, GMP, biologics, deviation, CAPA, quality controlAdditional Skills & Qualifications:Preferred Experience:--- A minimum 2-5 years work experience within a GMP environment working with small and/or large molecules.--- Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC/UPLC chromatography, including Waters Empower software is required.--- Provides technical writing for QC organization--- Responsible for authoring laboratory investigations, deviations, CAPAs and change controls.--- Conduct investigations thoroughly to identify all impact to patients, product quality, data integrity, validated state, and regulatory compliance--- Conduct root cause analysis to identify all contributing and potentially contributing factors related to the investigation--- Perform risk analysis as needed to determine likelihood and severity of recurrence--- Address impact to systems, processes, product, and any regulatory requirements--- Identify and develop relevant and effective CAPAs--- Monitor completion of lab investigations, deviations, and CAPAs--- Prioritize and organize laboratory investigations and deviations to ensure timely completion--- Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines--- Perform metrics as appropriate for laboratory investigations and laboratory operation parametersExperience Level:Entry Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.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: Actalent, Newark , Quality Control Analyst (Tech Writer), Professions , Newark, California