Responsible for executing all applicable changes timely, The Quality Assurance Associate may review performing and non-performing real estate loans to analyze Capacity, Capital, Character, Condition, Compliance, and Loan Integrity, including ensuring loans meet program and product specifications. Perform final QA review and provide final disposition for investigations, deviations and CAPA. Create a Resume in Minutes with Professional Resume Templates, Quality Assurance Associate Resume Samples. Collaborates with management and supervisory personnel from operations quality control and quality assurance to resolve problems affecting product quality. Industrious and focused Quality Assurance Specialist with 3+ … Will accept the equivalent of 10 years relevant industry experience if no degree, 5 years+ experience in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business, Previous experience interfacing with regulatory agencies, and a history of success and credibility resolving complex regulatory compliance issues, Organized, Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations, Must have strong collaboration skills “hands-on” operational orientation, Moderate to expert skill-level in Microsoft Excel and other Microsoft office programs is required, The role may also be responsible for authoring or assisting with procedure writing and/or training development or any other project related items for Inventory Management, This person will be trained and mentored by a Clinical Supply Logistics colleague, before working on the project, They will be responsible for regular interactions with MedSci partner lines, external vendors and quality assurance when clarity may be needed whilst reviewing/managing and transcribing data, Assists in providing disposition to bulk, intermediate, finished product and components based on batch record review for compliance to the current Good Manufacturing Practices, compendia standards and specifications. Sign in. Strengths: With over . Hassle-free … Quality Control / Quality Assurance professional, seeking a position in. Developed, implemented and monitored the Safety Quality Program in accordance to established guidance Coordinated and conducted safety inspections/audits Performed safety trainings Provided support to the Quality Operations Safety Program, made recommendations to eliminate and prevent unsafe conditions and practices Participated in accidents investigations. This app works best with JavaScript enabled. She has excellent attention to detail, can be diplomatic and supportive to team members and … Resume. Quality Assurance Manager Resume - Sample 1. Quality Assurance Project Manager in Portland Oregon Resume John Cleveland. CONTACT DETAILS: (phone hidden)/ (phone hidden); e Mail: (email hidden) Objective: Seeking middle level … Download Quality Assurance Associate Resume Sample as Image file, Quality Assurance Professional Resume Sample, Associate, Quality Assurance Resume Sample, Associate Director, Quality Assurance Resume Sample, Quality Assurance Engineer, Quality Resume Sample, Associate Quality Assurance Associate Resume Sample, Perform routine employee training file audits, prepare reports for respective department heads, and work with area management to resolve findings / issues, Assist with developing, revising, and reviewing SOPs. As such, it is not owned by us, and it is the user who retains ownership over such content. Quality Assurance Resumes: So, selecting a suitable resume template is also a duty of candidate. Work with QA Supervisor, when necessary, to resolve all pending items and escalate any outstanding exceptions over 15/20 days, Familiarize and understand the in’s and out’s of Flightpath system for efficient and accurate data entry of KYC information for business, individual, and trust entities. Assist QS in establishing and maintaining Quality Systems as they pertain to facility operation, Writes, reviews and processes the approval of Standard Operating Procedures, Assists in internal inspections and audits (manufacturing, QC, safety) to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and QS policy requirements, When necessary, assist with receiving, acceptance, handling, and storing of raw materials, Responsible for the continuous operation of the facility’s mechanical systems, monitoring systems and equipment. 4 Quality Assurance Manager Resume Samples, Examples - Download! Analyze organic and inorganic compounds to determine chemical and physical properties, composition, structure, relationships, and reactions, utilizing chromatography, spectroscopy, and spectrophotometry techniques. Any combination of education and experience equivalent to a bachelor’s degree, plus two years of progressively more responsible experience with audit review preferred. Top 21 Quality Assurance Resume Objective Examples You Can Use. Tips for writing your resume . Now that you know how to write a resume for open Quality Assurance positions, write a cover letter that will open doors with help from our Quality Assurance cover letter sample. TRAININGS AND Certifications 2, Good manufacturing practices and inspection. Liaise with customers to ensure customer requirements are satisfied. Analyze trends and generate reports/updates from these databases, May be required to conduct external vendor audits, May be required to attend off-campus training or COH training seminars, Masters of Science with 0 – 4 years of experience, preferred, Manage Vendor Qualification System Audit vendors: coordinate travel, audit, and provide audit reports to the vendor, Manage controlled substance activities: ordering and completing DEA 222 forms; receive, log, issue controlled substances for laboratory testing, and maintain logbooks, Manage the Product Complaint process: intake, process, investigate, and trend complaints, Speak with patients and follow-up with vendors, physicians, pharmacists, etc, Route manufacturing and quality documentation to vendors and management, Initiate, review and route deviations and non-conformance documents, Issue, review, and approval Change Controls CCs related to all controlled documents, Perform QA document review on manufacturing and quality documents, Establish training for other departments and directly train employees in other departments, Write, review, and revise SOPs, protocols, etc, Responsible for the QA/QC content review of clinical trial-associated documents for new and ongoing programs, Bachelor’s Degree in Science or related field (preferred), 5+ years’ experience within Clinical Quality Assurance. for improvement, Conduct side-by-side monitoring and coaching as requested by the supervisor/team lead or as need is recognized, Participate in monthly meetings and calibration sessions with third-party quality vendor, Complete analysis of results to identify root causes or trends that will lead to efficiency and quality gains in the contact center, Participation in new hire and skill enhancement training, helping to reinforce behaviors and processes that drive quality, Collaborate with supervisor and management to drive process improvement and technology initiatives aimed at creating efficiency and quality in operational processes, Assist in utilizing reporting tools that track performance at a department, team and individual level to measure quality rates, Assist with customer service calls, emails and spec creation as needed for business continuity purposes, Ability to work in and/or back-up all incoming call queues for the various segments within the department. MS degree a plus, Must demonstrate attention to detail and excellent record keeping skills, Knowledge of Microsoft Word and Excel required for review and preparation of documents and reports for inspections, Have, organizational, and time management skills and the ability to handle a multitude of tasks, Able to work effectively independently or in a team environment, Ability to interact well with employees at all levels, Excellent verbal, written, and interpersonal skills, Maintain a thorough knowledge of Alorica’s programs, policies, and technology, Maintain accurate and sufficient documentation admin records including, Participate in monitoring and calibration sessions with clients, Perform other duties as assigned by the Quality Assurance Supervisor, Ability to write reports, and business correspondence, Proficiency with Microsoft Word and Visio, 1-3 years of experience with data driven project implementations, Strong experience in project management activities, In-depth knowledge of all phases of the Software Development Life Cycle, In-depth knowledge of relational database technology and Structured Query Language (SQL), Understanding of financial markets and instruments, Experience with TestComplete is preferred, Ensure the inbound product is inspected when needed and signed off to Home Delivery Contractor to ensure 100% ownership of product and condition, accounts for all inventory in Remote Site via Tillscan. I love my job and I'm dedicated to ensuring high-quality medication and pharmaceutical processes. Also be familiar with any sponsor SOPs that may apply to studies, Review validation and project data for compliance to SOPs and Bioanalytical Procedures, Determine that no deviations from approved protocols/plans or Standard Operating Procedures were made without prior authorization and documentation, Assure compliance with GLP regulations and company procedures (SOPs and BPs), Troubleshoot and take the initiative on any QA-related issues with regards to GLP compliance, Submit to Study Director and/or Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken, Assist with performing study phase (in-process) inspections to ensure compliance and integrity of the study, Assist with maintaining training records of all employees, Assist with performing facility inspections to ensure laboratory maintains compliance, Support all other QA functions as required, Bachelor’s Degree (BA or BS) preferred; equivalent work experience/training considered, 2+ years of relevant experience in QA, QC, or in GXP (GCP, GLP, GMP) environment, Auditing cash receipts for quality and compliance of procedures used, Communicating errors, issues and solutions to leadership, Provide leadership with detailed information regarding monthly quality results, Communicating audit results monthly during the team meetings, Continually evaluates processes and procedures for team, Identify areas requiring training and ensure gaps are completely filled within given time frame, Enhance quality across organization and provide stable performance to customers, Works one-on-one with front line staff to educate and provide the training staff examples of common errors, 2 + consecutive years of cash applications and/or commercial collections (preferred), 2+ consecutive year of quality audit experience (preferred), High level of organizational skills, integrity and accuracy, Strong communication skills with excellent written and verbal communication, Strong attention to detail, analytical and problem solving skills, Excellent interpersonal skills working with internal and external customers, Proficient in Microsoft Office Suite plus proficient in use of Oracle (preferred), The ability to prioritize workload and meet tight deadlines, Must be a self-starter, able to work independently as well as be part of a team, Working knowledge of US Drug Product GMP requirements and associated guidelines, Experience in administration of quality systems for drug product manufacturing and quality control operations, 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry, Knowledge, Skills, Education and Experience, Ability to read and write in the English language, Navigate through various client-information based systems (OnBase, TotalPlus, CRB, and Flightpath) to review account documentation as assigned by QA Supervisor and update the QA Database with exceptions as necessary. Quality assurance managers strive to establish quality standards and procedures and also monitor constantly that the produced goods/service meet the agreed targets. … Show Resume Text. Responsible for dispositioning batches, Participates in company projects as a quality representative, Participates in risk assessment activities, Performs investigation report writing, reviewing and closing investigation reports, Performs various office-related duties; filing, scanning, and data entry, Promotes GLP/cGMP environment and follows procedural guidelines, Bachelor’s degree in any Life Sciences or equivalent and/or at least 5 years of relevant experience in QA or equivalent experience, Knowledge of cGMP regulations and good documentation practices preferred, Demonstrates excellent problem solving and critical thinking skills, Detailed oriented and good written and oral communication skills, Must be familiar with Microsoft Office applications, Knowledge of phases of the Software Development/Testing Life Cycle, Knowledge of relational database technology and Structured Query Language (SQL), Experience in JAVA, .Net, Ant, Java script, PowerShell, and MSSQL, Understanding of performance measurement and GIPS, Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience. Do you have a talent for listening and the ability to communicate easily with others? Balance the need for fast Time to Market with requirement for high quality customer facing materials, Assist the Training Quality Assurance Specialist to educate the ADLS staff on our process and template requirements, as well as enforce these on a day to day basis, Consistently improve and innovate our process, templates and tools, Document guidelines and standards for course developers to ensure consistency across globally distributed team. A highly efficient, methodical and talented quality assurance supervisor who has considerable experience of developing and implementing effective quality control processes and structures in a manufacturing and corporate environment. Karen has experience of the day to day management of a QA team to support production in the factory and compliance of all quality policies. ), Identifies and resolves problems in a timely manner, Focuses on solving conflicts and listening to others without interrupting, Balances team and individual responsibilities and helps build a positive team spirit, Adapts and able to deal with frequent changes in the work environment, Able to manage difficult or emotional customer situations and respond promptly to service requests to meet customer commitments, Demonstrate accuracy and thoroughness to meet productivity standards in a timely manner, Required to exert physical effort in handling objects less than 30 pounds rarely, Required to be exposed to physical environment which involves dirt, odors, noise, weather extremes or similar elements rarely, Normal setting for this job is: office setting, Be passionate about providing CAPA quality assurance support for a world-class manufacturer, At least 2 years' experience in a Quality Assurance role in the medical-device, pharmaceutical, or biotech industry, Sound knowledge of FDA quality system regulations and ISO standards, Bachelor's degree in an applicable science or engineering, Excellent interpersonal skills and high professionalism, Minimum 2+ years Administrative Support or Document Control is preferred, Outstanding oral and written communication, Support relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business in compliance with QMS principles, Build strong relationships across the LOC Commercial Business functions and work with them to develop meet quality objectives, Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity, Represent GSK Australia LOC at relevant QMS forums, QMS implementation and monitoring of compliance within the Australian Rx LOC. Also note how the quality assurance specialist resume template for Word utilizes strong action verbs at the beginning of each line. Implemented corrective and preventive actions Write technical papers and reports; and prepare standards and specifications for processes, facilities, products, and tests Responsible for maintenance and update of laboratory information management system (LIMS) Prepared internal reports and made presentations to the work group Maintained lab supplies in collaboration with other members of the chemistry group. Save the space on your resume for the sections illustrated on the quality assurance specialist resume sample and leave out any mention of references. compliance to Bell Branding, Dress code, Bell collateral, Kiosk condition, etc. Uncertain deadlines, the lack of control over the pace of decision-making by other Bank departments and some external counterparties at times can create frustration and delays, College degree preferred, or 3 years commensurate experience within Olympic Steel is required, Proficiency in Lotus Notes, MS Word, MS Excel applications and Olympic production control computer systems, Knowledge of customer service standard and procedures, Strong organizing, planning, prioritizing and multi-tasking skills, Strong interpersonal/communication skills with the ability to work effectively with a wide range of constituencies, Quality Assurance testing of Company software applications and ensuring that functionality meets design specifications and business requirements, Design and execute manual tests and report findings, Provide high-level input as to the testing approach and methodology to be used in the testing of each application. Compilation ANDA / Dossier and submission of annual updates for ANDA / Dossier. Scene7 and Drobo), Basic SnagIt and/or image editing tools for screenshots, 50% Product safety and quality systems implementation, maintain ingredient approval, training, assessment, and compliance, 20% Proactively manage and resolve product safety and regulatory issues in collaboration with head office quality team, regulatory affairs insuring root cause identification and preventative actions. Maintains high level of professionalism and acts as calming influence in all situations. Don’t let the same happen to your resume when the recruiter examines it. Led remodel of the Quality Department prior to initial FDA inspection resulting in zero form 483's issued. QA/QC Analyst ( Pharmaceuticals) Location: United States. Resume for the Position of Qa-qc Welding Inspector or Qa-qc Mechanical Engineer. ), Developing procedures and initiating change documentation in support of FPP for new and existing products, At least 2 years of Quality Assurance or related experience in a medical-device, pharmaceutical, biotech or other regulated industry, Demonstrated working knowledge of FDA medical device quality system regulations and ISO medical device industry standards, Bachelor’s degree in an applicable science or engineering, OR a 2-year degree plus 2-5 years medical device or pharmaceutical experience in a manufacturing or operations role, Experience supporting various manufacturing processes, Responsible for overseeing quality activities to ensure success against quality KPIs, including the quality associated with inbound call and email customer interactions, updates to existing customer services and set-up of new customer services, Supplement monitor allocation performed by quality vendor, focusing on individual support and coaching for low performing agents, Perform ticket audits of each operations team, ensuring the proper documentation and workflow of service request per internal procedure, Conduct audits of services to ensure SOX compliance, Produce reporting based on audits and offer suggestions, job-aids, etc. 5Why, 8D, Ishikawa Diagram), Supporting and leading the management of change process, Participating in selection, qualification, and management of suppliers and service providers, Participating in process improvement teams to provide quality input and direction, Continually evaluating systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards, Bachelor's Degree in a technical discipline with at least 5 years' experience in a Quality Assurance related role, At least 2 years of work experience with ISO 9001 or other Quality Management Standards (ISO 13485, AS9100, etc...), Canada Walmart Division:* Distribution Centre, Provide guidance to technical areas within the laboratory in order to meet all regulatory and client requirements, Direct the planning, hosting, coordinating of audits performed by sponsors and regulatory agencies, Follow-up on action items and CAPAs that arise from routine Client, Regulatory audits or other quality issues that arise to ensure appropriate and timely escalation, CAPAs and closure, Schedule, coordinate, and document in-house QA / regulatory training program for technical and non-technical areas performing FDA / EMEA regulated work and other appropriate areas as directed by QA, Compliance, or business, Perform audits of Quality System including audits of corresponding documentation to ensure compliance, Direct the planning and execution activities of a team of direct reports as well as resourcing within the larger QA organization, Direct, lead, coordinate and participate in qualification audits of subcontractors, referral labs and or vendors as requested, Manage and perform internal Pre Study, Study and Post Study audits in relation to Bio-Analytical / Bio Equivalence, Perform raw data audits to ensure accuracy and compliance to all applicable regulations and local SOPs, Determine if and assure that study deviations are appropriately documented and communicated, Coordinate the assembly of the Bio-Analytical report and upon compliance sign off as required, Bachelor’s degree in a life sciences related discipline, 10+ years Quality Assurance Laboratory Management experience in pharmaceutical, technical, or related area, Strong knowledge of CAP, CLIA regulatory requirements, Strong interpersonal and communication skills; must be confident interfacing and speaking with auditors, all levels of management, and senior level executives, Extensive knowledge of pharmaceutical research and development processes and regulatory environments, Senior Lab Management experience in Quality Assurance, Ability to influence and guide others at all levels of management, Working knowledge of GCP, ISO 15189, ISO 9001 requirements, Demonstrated ability to manage costs effectively through appropriate resource allocation, Demonstrated ability to articulate and define departmental needs and processes, Demonstrated ability to establish and maintain effective working relationships with coworkers, managers and clients, Demonstrated knowledge of Microsoft office suite and database applications, Excellent leadership and motivational skills, Quality representative on internal and external CMC project teams with decision making authority, In conjunction with technical representatives - review and approve manufacturing and testing Deviations/CAPAs, Review and approve cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet GMP and internal standards, Review executed batch production records to ensure compliance with approved procedures and GMP expectations. 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