HI, Hope you are doing great!
This is Harry from Dynamic Enterprise Solutions. We have urgent requirement with one of our client's, please review below job description and let me know your interest Position ID: DYESFK1843 Job Title: Regulatory Affairs Contractor Location: Lake Zurich, IL Duration: 9 Months+ Strictly Locals Only (On site work Required from Day1) Job Description: Summary: The main function of a regulatory specialist is to implement policies and coordinate community affairs strategies. A typical regulatory specialist will develop and maintain supportive relationships with regulatory bodies. Responsibilities . Compile and maintain regulatory documentation databases or systems. . Coordinate efforts associated with the preparation of regulatory documents or submissions. . Analyze product complaints and make recommendations regarding their reportability. . Develop or conduct employee regulatory training. . Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. . Escort government inspectors during inspections and provide post-inspection follow-up information as requested. . Coordinate, prepare, or review regulatory submissions for domestic or international projects. . Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Skills: . Verbal and written communication skills, attention to detail, customer service and interpersonal skills. . Ability to work independently and manage one's time. . Knowledge of legal policies and procedures related to hiring practices (i.e., equal employment opportunity and affirmative action). . Knowledge of benefit and pay-scale systems. . Previous experience with computer applications, such as Microsoft Word and Excel. Education/Experience . Bachelors degree in related field desired . 2-4 years of experience Position ID: DYESFK1840-1 Title: Track Wise Technical Writer Location: Wilson, North Carolina Duration: 3 Months+ Strictly Locals Only (On site work Required from Day1) JOB DESCRIPTION This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of thisjob. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability POSITION SUMMARY The Technical Writer is responsible for independently investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT . Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process. . Responsible for managing multiple deviation investigations simultaneously. . Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations. . Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations. . Works with process experts and production personnel to fully understand and solve problems, . provides technical expertise and recommends improvements. . Writes Impact Assessments and Investigation Reports, works within TrackWise. . Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems. . Performs continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected. . Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board. . Utilizes Word, Excel, Documentum and other electronic systems to complete tasks. . Maintains compliance with company policies, training requirements, cGMPs and safety standards. REQUIREMENTS . BS/BA degree(experience may be considered in lieu of degree). . Must have at least three years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports . Requires advanced critical thinking skills . Must be familiar with regulatory (FDA) requirements . Good organizational, communication, and interpersonal skills are necessary Position ID: DESAL00013203 Job Title: Terraform Engineer with Windows OS Location: North Chicago, IL Duration: 9-12 Months+ Locals Preferred Hiring Manger Notes: Manager have informed the following: The specific position we are looking for is a Windows OS engineer with background in building a windows image using Terraform and Packer. If the person has Devops background, that is a plus but we need someone that can immediately step in and be a Windows OS SME. This position is On-site preferred; work hours: 8:30am - 4:30pm or 9am - 5pm. Job Description: Manager is looking for an Infrastructure Automation Engineer to help build out their Infrastructure as Code platform using Terraform and Packer. Candidate will work closely with Client's Cloud/DevOps Architect to take the architecture designs and build out services in Terraform. This role will be heavily involved in writing scripts, configuring modules and deploying services in support of Client's IaC strategy focused on both IaaS and PaaS platforms. The Infrastructure Automation Engineer will help enable the adoption of an Infrastructure-as-Code approach to provisioning and configuration management, and CI/CD enablement and automation across Client's public and private cloud environments. is looking for an Infrastructure Automation Engineer. Top Skills: 1.) Strong knowledge of HashiCorp (Terraform & Packer) 2.) Knowledge of Infrastructure As Code Methodology 3.) Scripting skills (Bash or Powershell) 4.) Windows Server Build Automation 5.) Threat Vulnerability Management (Packaging of Application Updates) This position is On-site preferred; work hours: 8:30am - 4:30pm or 9am - 5pm. Thanks & Regard's Harry John Dynamic Enterprise Solutions Inc 1801 Hicks Rd, unit A Rolling Meadows, IL -60008 (847) 719-7902 /C 224-635-0898 Email: ha...@dynamic-enterprise.net -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . Please read http://groups.google.com/group/rtc-linux/web/checklist before submitting a driver. --- You received this message because you are subscribed to the Google Groups "rtc-linux" group. To unsubscribe from this group and stop receiving emails from it, send an email to rtc-linux+unsubscr...@googlegroups.com. To view this discussion on the web visit https://groups.google.com/d/msgid/rtc-linux/205601d73adf%247c49d350%2474dd79f0%24%40dynamic-enterprise.net.
