Document Control Specialist

Company: Actalent
Location: Laguna Hills
Posted on: September 25, 2022

Job Description:

Immediate Document Control Job Opportunity For Immediate consideration please apply directly to this posting and email your resume to Description:--- Manage the Document Control Dept. and direct reports to maintain and continuously improve the process to meet regulatory compliance and established quality objectives.--- Manage the Document Change Order (DCO) Process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records per the Adagio's Standard Operating Procedures.--- Manage the Change Control Board (CCB) to process DCOs, implement changes, complete product disposition, and complete all DCO activities in a timely manner.--- Maintain compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.--- Lead the implementation of the automated eQMS system (QCBD) for all change orders activities, document control processes, part number maintenance, and associated record keeping. --- Manage the employee training program and maintain the training matrix by working with the hiring managers to ensure current training records, job description, and employee records are incompliance with Adagio 's Standard Operating Procedures.--- Maintain control of electronic and hard copy of documents for SOPs, product specifications and drawings, inspection and manufacturing procedures, clinical documentation and protocols, process validation, design control, marketing and educational material and test reports.--- Maintain and update Master Document List and Document Change Control Logs to ensure consistency and record keeping.--- Maintain Design History Files, Regulatory Technical files, Device Master Records, and other Design Dossier documents.--- Coordinate internal audits in compliance with the company's internal audit procedure.--- Maintain the quality systems databases for the purposes of providing quality metrics data on routine basis or as required.--- Prepare document control trending information and prepare data summaries for management review meetings and other similar meetings as needed--- Coordinate with the Management Representative during external audits (FDA, Notified Body, California State Department of Public Health)--- Direct assistance to the CCO during product development projects to ensure compliance and regulatory requirements are met throughout the development process.--- Direct assistance to the CCO during regulatory submissions, responses, and communication with regulatory agencies such as the FDA and Notified Body.Skills:Document, control, revision, quality, ISO, design, historyTop Skills Details:Document, control, revision, quality, ISO, design, historyAdditional Skills & Qualifications:BA/BS in Health Science or similar with prior experience in medical device regulated environment.Previous knowledge in document control change process, document control activities, purchase orders, supplier qualification, and product inspection and release.Previous (2 - 3) years experience/knowledge medical device regulations and good manufacturing practices.Experience Level:Intermediate 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, Los Angeles , Document Control Specialist, Other , Laguna Hills, California