Quality Engineer-CAPA/NCMR

Waukegan, IL

Posted 34 months ago

Position No Longer Available

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Position No Longer Available

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Job Description

Quality Engineer-CAPA/NCMR **job details:** + location:Waukegan, IL + salary:$75,000 - $85,000 per year + date posted:Wednesday, May 19, 2021 + experience:5 Years + job type:Permanent + industry:Professional, Scientific, and Technical Services + reference:36320 **job description** Quality Engineer-CAPA/NCMR job summary: **Quality Engineer** **-CAPA/NCMR** **Reports to Quality Assurance Manager** **JOB SUMMARY** The Quality Engineer-CAPA/NCMR job function is to provide assurance that all products produced in the facility are in compliance with the applicable regulations and company policies and procedures. The incumbent will also serve as a technical resource to product development, manufacturing and suppliers to improve process capability, reliability and the quality of products. Specific primary efforts will be directed towards the Corrective and Preventive Action (CAPA) system, Nonconforming Material Reports (NCMR's) and its affiliated arteries into the facility's various systems/processes/programs, oversight of training programs, and participation in customer and regulatory audits. The CAPA Coordinator position requires exercises in judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to a diverse scope of problems. Evaluation of data and/or systems is part of the problem-solving process. location: Waukegan, Illinois job type: Permanent salary: $75,000 - 85,000 per year work hours: 8 to 4 education: Bachelors responsibilities: **ESSENTIAL DUTIES AND RESPONSIBILITIES** **Perform all of the duties and responsibilities of** Quality Engineer-CAPA/NMCR 1. **Maintains and Monitors the CAPA System** - Administers and is the subject matter expert for the entire CAPA system and process, specifically in relation to Nonconforming Material Reports (NCMR's), OOS investigations, Deviations, OOT reports, Cleaning Failure Investigations, Product Recalls, Environmental Monitoring Investigations, Purified Water Investigations, and Stability Investigations. Supporting roles/functions that will be involved are: + Ensure compliance with GMP regulations and internal policies/procedures. + Ensure accurate and timely processing of all Quality documents/records. + Arrange and/or attend meetings that involve, directly or indirectly, quality issues. + Actively participates in team activities with all departments to ensure that the manufacturing processes are compliant with company procedures as well as FDA/ISO regulations and standards. Overseeing closure of corrections and corrective actions in a timely manner. Specifically managing actions (including required documentation) and communicating with all necessary departments in order to track and close out actions. + Perform tracking functions with the CAPA system. (i.e. Operations, Manufacturing, laboratory) to ensure all information is complete so that investigations and corrective actions are thorough and documented. + Lead and/or participate in root cause analysis for all CAPA investigations. + Perform all effectiveness checks for the CAPA system. Based on these checks/follow-up activities close out the CAPA record or provide/suggest remediation plan to the departments. + Assess the CAPA system (documentation/practices) on a frequent basis to ensure the system meets current industry best practices and stated regulations for API, Excipient and Food Additive manufacturing. 1. **Risk Assessment and Monitoring** - Perform investigations and root-cause analysis activities as they relate to Corrective/PreventativeActions (CAPA), and drive continuous improvement based oncollection of facts and drawn conclusions from investigations; resultingcorrections/corrective actions be able to assess risk, based on currentrisk guidelines, for the end product as to the efficacy/safety of thisproduct in finished formulations. Communicate this risk assessment toQuality Management. 1. **Audits** - Participate as an active member of the various audit teams.Assist in customer audits, FDA /inspections, supplier audits as well asinternal audits. Conduct internal audits of Quality Systemsin regards to GMP. Act as the team leader in formulating responses toaudits/inspections in relation to the CAPA system as a whole. Performaudit follow up for completing commitments to auditresponses. Track and trend all audits and associatedobservations/corrective actions in the CAPA system. Identify, initiateand lead process and compliance improvement. Implementimprovements and methods for measuring effectiveness of changes. 1. **Regulatory** - Ensure any actions generated form the CAPA system that impact or have potential Regulatory impact is reported to Quality Management as a priority. Independently, create and interpret a Quality Metrics report based on the CAPA system. Present relevant trends to Senior Management at review meetings. Make recommendations based on the conclusions of the report. 1. **Training** - Train personnel in corrective and preventive action concepts as deemed necessary and applicable by the QA Management. This includes products in design and development as well as products in production and the processes which support them. 1. **Maintains and organizes Management of Change (MOC) program** ,ensuring all critical changes at the site are tracked through completionand approved according to internal procedures. Lead by week MOCmeetings to ensure projects meet deadlines and project leads areproviding sufficient data, documents, and materials to ensurecompliance and closure. In conjunction with engineering andmanufacturing, assist with the implementation and maintenance ofstatistical process controls were applicable. 1. **General** - Operation in accordance with company policies, standardoperating procedures, environmental, Health & Safety guidelines. qualifications: **QUALIFICATIONS** + A BS/BA degree in Engineering or Life Sciences, a technical field and/or 5+ years of Quality experience in biotechnology/pharmaceutical arena. + Minimum of 3 years of Quality Engineering experience in a regulated Environment (Medical products, Pharma, Biotechnology, or Aerospace preferred.) + Team leadership, project management skills are essential. + Good observation, organization, prioritization and problem-solving skills. Ability to define problems, collect data, establish facts and draw conclusions. + Working knowledge of the cGMP regulations, ICH Guidelines, QSR (FDA) & ISO industry standards for APIs, Excipients, and Food products would be beneficial. + Good computer skills (Database, Microsoft Office programs associated with compliance tracking). + Familiarity with ASQ QE Certification, Statistical process Controls (SPC), Design and Process Validation are also highly desirable. + Strong communication skills (oral and writing strength). **PHYSICAL REQUIREMENTS** + Must have good hearing and sight - adequate for safety programs in a pharmaceutical manufacturing plant + Must be able to sit and/or stand for extended periods + Ability to work effectively under pressure to meet deadlines + Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening + Must be able to lift 50 lbs. + Ability to wear proper safety equipment when working in plant skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Position No Longer Available

Job Summary

Company

Randstad

Start Date

As soon as possible

Employment Term and Type

Regular, Full Time

Required Education

Bachelor's Degree

Required Experience

5+ years