Report findings to management. Vol. from four-year college or university, Development, implementation and maintenance of Stryker South Pacific Quality System, Liaise with relevant SSP and Corporate process owners regarding development & implementing process requirements, Monitor site implementation of the Quality System requirements, and provide mentoring, assistance and training to process representatives, Develop and / or revise QS process procedures to incorporate appropriate regulatory and corporate requirements, Monitor the quality standard activity and ensure Management is informed in a timely manner of changes/trends that could affect SSP’s Quality System, Check overall product quality and measure product utilizing predetermined points of measurement and comparing against standards and spec sheets, Fit apparel on body form to confirm fit, identify inconsistencies and make fit recommendation, Enter measurements, fit recommendation and descriptive product details into PDP, Systemically move product that has been checked to the next location, Enter PID details into QC Product Tracking document for metric tracking, Biology or other Life Science degree is preferred, At least 1 year of work experience in a GMP (Good Manufacturing Practice) facility is preferred, At least 1 year of experience working with and/or auditing batch records is preferred, At least 1 year of experience working with Standard Operating Procedures and associated documentation within a regulated industry is preferred, At least 1 year of technical writing experience is preferred, At least 1 year of experience performing visual inspections for cleanliness is preferred, At least 1 year of experience performing inspections for process conformance and complete documentation is preferred, Flexibility to work a non-traditional shift is required, Microsoft Office Suite proficiency is preferred; this includes Microsoft Outlook, Word and Excel, Lean Six Sigma, ASQ certification or other related professional certification is preferred, Review assay data, protocols, reports, technical specifications, certificates of analysis, RIRs, Cell banking Production Records for compliance requirements, Review lab records, batch records, SOPs and other documents for auditing requirements, Interact with other departments to ensure compliance with internal procedures and FDA regulations, Zero to one year experience in Quality Assurance or related field within a GXP environment, Introductory to working knowledge of FDA regulations (cGMP, GLP, Part 11), Working knowledge of good documentation practices, Good oral, written communication and interpersonal skills required, Assist in the development of Standard Operating Procedures in order to maintain quality systems in line with current regulations, BMS directives, and industry standards, Lead tagging efforts of released direct materials for production, Scan/Submit completed documents for document system archival, Author Standard Operating procedures, Forms, and other Operations related documentation, Assist with monitor and inspect the production facility during product manufacture and notify QA and other departmental management of potential quality issues, Participate in corporate audits and FDA or other health authority inspections (as needed), Assist in the preparations of periodic trend reports of quality data such as deviation, CAPA, Quality Council data, Other duties as requested, Bachelor's Degree in scientific or technical discipline plus, Performs Quality Assurance audits of the entire FAO DOL operation, Monitors and audits department operating procedures, Reviews weekly statistics and record data necessary for analysis of key processing areas, Generates daily, weekly, and other periodic reports, Compiles monthly/weekly QC sample data required by the client, Provide support for individual department quality control processes, Maintains Quality Assurance Procedures manual, Analyze quality control data and make recommendations to departments based on findings, Good organizational skills and decision-making ability, Must be able to work independently and multitask, Experience using Microsoft Office applications, Must have the ability to analyze data, determine needs, implement solutions and track results, Previous quality control or claims processing experience preferred, Minimum of 1 year work experience in a BPO / Call Center Industry catering US Healthcare services, Bachelor’s Degree/Associate Diploma Holder, Wide knowledge on Healthcare Revenue Cycle, Participate in the creation and approval of complete, unambiguous, and measurable design outputs, Review and approve specifications, including those for raw materials, intermediate products and finished products, To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485, Holds a professional scientific qualification e.g. Collaborate with product specialists and others to effectively deliver solutions to customers, Effective problem solving – undertakes comprehensive analysis of problems to assess most effective solutions and enlisting support of others to ensure problems are adequately solved, High levels of tenacity and EI (emotional intelligence) – pursue everything with energy, drive, agility and a need to deliver in the face of resistance or pushback. Top 8 quality assurance associate resume samples 1. sterilization, raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, manufacturing, engineering, etc. Perform final QA review and provide final disposition for investigations, deviations and CAPA. Will be the QS lead on manufacturing projects as assigned. Have worked in a Consent Decree environment and fully understand the importance of compliance. After logging in, come back to this page and refresh your browser. It’s actually very simple. © 2020, Bold Limited. Posted: April 18, 2011. Crafting a Quality Assurance Associate resume that catches the attention of hiring managers is paramount to getting the job, and LiveCareer is here to … Look at the quality assurance resume sample to see how to condense your information effectively. Any combination of education and experience equivalent to a bachelor’s degree, plus two years of progressively more responsible experience with audit review preferred. Seek continuous technical quality improvements, Assist QA team members with maintenance of Quality (Q) Agreements in support of Elanco R&D team’s activities. Establishes requirements and assures product conformance through appropriate inspection and test activities, Develops and implements quality strategy and objectives, Identifies and solves product and process problems and supports various operational groups, Prepares and monitors operating and capital budgets, Responsible for development and oversight of departmental goals and projects, Communicates and escalates issues to Sr. Management as required, Requires extensive independent decision making ability and applying regulations and standards (ISO, QSR, etc.) SOFTWARE SKILLS CERTIFICATION TECHNICAL SKILLS. 19.4 PROCuReMeNT however, in a resource-constrained setting, the risks to patients … Strong analytical and problem solving skills. Stay up to date with all Flightpath system changes. Project on Quality Control in Pharmaceutical Company. Best Quality Assurance Resume Example | LiveCareer. Resume Qa Qc . A hands on and committed Quality Assurance manager who is able to drive and achieve the highest production standards through effective line management. Performs area assessments and ensures compliance in all activities with cGMPSs and Compliance activities Track and management of deviations/investigation/CAPA systems in Trackwise Evaluates Corrective Action/Preventative Action (CAPA) effectiveness; interacts with internal/external Quality Assurance groups. Do not increase your burden by searching for the best resume … Some of their responsibilities are coordinating quality assurance programs, developing quality control procedures, making sure customer demands are respected, and training other employees with regard to quality assurance issues. May contribute to training content, Develop Quality skills to provide support for customers and for implementation of legal regulatory quality requirements. One of our users, Nikos, had this to say: [I used] a nice template I found on Zety. Reviews and recommends approval of indicated actions to senior Auditors, Assist Document Control in review, filing, and issuance of AMRI documents, In conjunction with senior Auditors, conducts Self Audits of all areas of AMRI and assists with writing audit reports, In conjunction with senior auditors, acts as QA liaison to assigned project teams, Assists with customer/regulatory agency audits when necessary, Writes and reviews Annual Product Review reports, Writes protocols for Process Validation Protocols and assists with writing of Process Validation Reports, Assists with customer inquiries and investigations of customer complaints, Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, SOPs, and current compliance standards, Ability to audit documents, procedures, and records for accuracy and continuity, This position requires a B.S.