Quality Systems Resume Sample
Coby Schaefer
4620 Scottie Summit,
Chicago,
IL
+1 (555) 626 3255
Work Experience
Quality Systems Associate
02/2016
-
PRESENT
New York, NY
- Conceptualize, reason through problems, make effective decisions and develop alternative solution and provide excellent customer service while ensuring compliance with the American Heart Association’s policies and procedures
- Prepares written documents describing analysis techniques and test results. Writes and reviews SOP’s and other quality documents and reports
- Provides support for sample gathering and data recording for plant trials, 1100’s and research efforts
- Performs audits to verify compliance with established SOP documentation, GMP’s and Safe Quality Food (SQF) efforts
- Provides support for Infinity (i.e. table maintenance, add new SKU’s, review results)
- Knowledge of Good Manufacturing Practices (GMP’s), SQF and HACCP/HARPC
- Understanding technical vendor manuals and Standard Operating Procedures (SOP’s)
Quality Systems Coordinator
03/2010
-
09/2015
Dallas, TX
- Collate and present clear and concise quality data to the Quality Manager and Plant Management to measure the effectiveness of the quality system
- Provide reports/information to management on quality-related issues and implement solutions to quality-related issues
- Act as the primary associate responsible for support in preparation for internal and external audits
- Train personnel on applicable compliance issues
- Interface with other departments to ensure that Quality system requirements are met or exceeded
- Make decisions in an independent mode, if necessary
- Be accountable for the growth, career progression, and discipline of employees
Quality Systems Support Intern
07/2007
-
01/2010
Chicago, IL
- Active Member of the Document Change Review Board (DCRB) ensuring the effectiveness of Garmin’s quality management and compliance systems
- Experience working with product development team in a QA position or in a data analytics team
- Implement, monitor, and maintain Quality System requirements, develop procedures that affect operational and compliance status, and work with the divisional quality representatives as appropriate to ensure compliance with corporate policies
- Implement, monitor, and maintain efficient and effective quality systems that comply with all current medical device regulatory requirements. Provide direction to the implementation of effective CAPAs, nonconformance reports (NCR), change control documents, and audit programs, and review the results of monitoring of effectiveness checks
- Responsible and accountable for the NCR and rework process and metrics
- Responsible for site Product Hold, Initial Impact Assessment and Field Action
- Implement, monitor, and maintain quality analysis systems, in line with best industry practices, to efficiently provide key data related to the quality system
- Implement, monitor, and maintain training programs for plant personnel and leaders to ensure qualification requirements are identified, maintained, and met
Education
Chatham University
2002 - 2007
Bachelor's Degree in Science
Professional Skills
- Excellent written, verbal and presentation communication skills and Training skills
- Demonstrated teaming skills, including the ability to work effectively with other organizations, project sponsors, directors, and managers\
- Strong computer skills with ability to rapidly adapt to unfamiliar programs. Experience with Microsoft Word, Excel, and PowerPoint desired
- Skills include good interpersonal skills and works well with people at multiple levels of the organization
- Strong organizational & follow-up skills, with the proven ability to multi-task
- Strong communication skills, both written and verbal, in order to effectively communicate at all levels both internally and externally
- + Demonstrated skills in working with leadership, communicating leadership decisions, principles and intent and translating those decisions into change
How to write Quality Systems Resume
Quality Systems role is responsible for computer, organizational, interpersonal, leadership, microsoft, software, organization, database, excel, analysis.
To write great resume for quality systems job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Systems Resume
The section contact information is important in your quality systems resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Quality Systems Resume
The section work experience is an essential part of your quality systems resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality systems responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality systems position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Systems resume experience can include:
- Quality Metrics Management – Responsible for the collection, reporting, and continuous improvement of Quality Metrics. Trending of Quality Investigations, Out of Specifications, Out of Trends and Corrective and Preventive Actions on quarterly and annual basis
- Ensures all Deviations, Investigations, Lab Events, OOS and OOT’s are properly investigated and provides final approval for all in investigations. Ensures a robust deviation management program is executed to ensure effective root cause analysis and corrective and preventative action identified and completed
- Actively participates in Site/Quality meetings and works with multi-functional Quality team, Planning, Manufacturing, Packaging, Maintenance, and others as required to resolve tactical issues, and satisfy quality and production needs
- The incumbent requires strong organization skills, communication skills and the ability to work both independently or as an integral member of the team
- Experience in executing process validation, having led and managed validation projects
- Strong communication, influencing, and negotiating skills
Education on a Quality Systems Resume
Make sure to make education a priority on your quality systems resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality systems experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Quality Systems Resume
When listing skills on your quality systems resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical quality systems skills:
- Excellent organisational and time management skills; with the ability to prioritise effectively
- Strong interpersonal and listening skills and the ability to effectively interact with all levels of LMI personnel and vendors in a professional manager
- Strong computer skills to include Microsoft suite, IDEA for CON and organizational skills
- Demonstrated experience and skills for problem solving, troubleshooting
- Organization and communication skills to effectively work with internal personnel, customer
- Strong organizational and time-management skills; prioritizing work and eliciting relevant information as part of a team and as a leader
List of Typical Experience For a Quality Systems Resume
1
Experience For Quality Systems Coordinator Resume
- Strong communication, teamwork, and problem-solving skills as well as root cause analysis skills
- Strong business acumen, strategic and tactical execution abilities, including strong organization skills are required
- Strong analytical mindset with excellent interpersonal and leadership skills
- Strong interpersonal and presentation/training skills
- Superior oral and written communication skills; aligning requirements and process needs with effective implementation
- Strong leadership and organisational skills and
- Demonstrated ability to effectively interface with management, customers, and stakeholders at all levels\
- Excellent verbal and written communication and presentation skills\
- Excellent root cause analysis and investigation skills
2
Experience For Quality Systems Supervisor Resume
- Demonstrated analytical skills and a system approach to problem solving with an emphasis on process development and optimization, not just system maintenance
- Experience in manufacturing experience (aerospace or automotive)
- Prioritize projects and adapt to shifting priorities
- Demonstrated experience producing technical reports
- Previous experience working with quality systems a strong asset
3
Experience For Quality Systems Technician Resume
- Train and assist staff to effectively utilize the quality management system when managing projects
- Train and develop other STERIS employees on quality principles, effective corrective actions, and valid statistical techniques
- Experience in equipment validation methods desirable
- Prior experience with the development and/or maintenance of Key Performance Indicators, Quality Indicators, Scorecards and/or metrics
- Manage the Global Management Review program to effectively monitor Celgene’s quality systems at the global level and ensure continuous improvement
- Prior experience working in a lab environment
- Working knowledge of FDA regulations and Good Manufacturing Practices
- Experience as Molex quality technician (Ex: performing FAI, receiving inspection, posting, facilitating meetings, formal Green Belt training)
- Experience developing, delivering, and evaluating training
4
Experience For Quality Systems Associate Resume
- Experience working with internal and external customers and meeting the demands specified
- Experience in writing standard operating procedures, specifications and technical reports
- Experience in auditing for medical devices, drug and biologic engineering, etc
- Demonstrated understanding of industry regulations, including detailed knowledge of FDA QSR’s and ISO 13485
- Solid technical understanding of medical device auditing
- Manage an effective and efficient filing and archiving system of NorthStar documents. Interact with offsite suppliers for Document storage and retrieval
- Manage internal training for Product Experience Handling Process
- Experience in manufacturing/ manufacturing science and technology/technical development/Quality
5
Experience For Quality Systems & Compliance Manager Resume
- Manage competing and evolving priorities in a fast-paced environment
- Experience initiating and driving projects to completion with minimal guidance
- Manage competing and evolving priorities in a fast paced environment
- Previous experience of medical device complaint management including adverse event reporting to competent authorities - Desirable
- Experience implementing continuous improvement projects within quality systems and coordinating field safety corrective actions
- Experience managing complex projects\
- Experience working with the Department of Energy, the National Nuclear Security Administration, or the Department of Defense\
- Responsible for authorizing the return of any products (Raw Material/WIP/Finished Goods) to MPS
- Responsible for SQM metrics consolidation & reporting
6
Experience For Specialist, Quality Systems Resume
- Effectiveness and approving recommendations of others
- Demonstrated ability to deliver solutions in a timely fashion under rapidly changing conditions
- Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance
- Extensive experience in cGMP manufacturing, Quality Control (QC), or Quality Assurance (QA)
- Experience in a quality organization of a manufacturing industry (preferably medical devices or pharma)
- Own and implement a consistent and effective document hierarchy plan for the GCM system, including local and global elements
7
Experience For Supervisor, Quality Systems Resume
- Provide leadership to drive effective collaboration across QMS councils and manufacturing sites
- Experience working in a regulated environment
- Review and approval of validation and qualification documents, including protocols and reports
- Supervisory experience in quality and/or manufacturing in a Biotech environment helpful
- Experience in presenting information to department managers and executive management
- Good decision making and ability to balance day-to-day tasks with all continuous improvement activities
- Oversee product experience/complaint events within Complaint Handling System
- Detail-oriented, consistently producing high quality, accurate work appropriate to broader context and priority
8
Experience For Quality Systems Lead Resume
- Experience of working across wide span of Quality and, ideally, operational disciplines
- Experience doing business process analysis
- Related experience as a quality systems coordinator or equivalent at a corporate and/or manufacturing plant level
- Experience in Original Equipment Manufacturing (OEM) as a supplier
- Proven success driving quality issues to the root cause through collaboration with operations and maintenance
- Manufacturing quality experience
- Familiar with design process, project flow & control, risk assessment & management, process validation & verification , statistics & sampling plan etc
- Relevant experience in a Pharmaceutical GMP setting
9
Experience For Analyst, Quality Systems Resume
- Demonstrated ability to work across all levels including executive management and production associates is required
- Able to deliver results while working under tight deadlines and balance a variety of priorities
- Experience using MS Office, Lotus Notes, EtQ, Databases, etc
- Three or more years of work experience in Quality or Food Safety in a food manufacturing environment
- Experience with FSSC 22000 implementation in a multi-discipline food manufacturing or Quality environment
- Previous experience with Agile/Arena structure and functionality including workflows and search
10
Experience For Manager, Global Quality Systems Resume
- Experience working as Function, Data, or Business Analyst
- Maintain and demonstrate understanding of global standards and regulations
- Responsible for the assistance of the Chemistry Laboratory staff for the execution of validations protocols covering laboratory operations
- Previous experience in a pharmaceutical manufacturing or Quality environment considered an asset
- Previous experience in a laboratory setting is considered an asset
- Experience in food industry in quality control and/or assurance role (GMP Food Manufacturing related quality)
- Experience with document formatting
- Experience working in a regulated organization
List of Typical Skills For a Quality Systems Resume
1
Skills For Quality Systems Coordinator Resume
- Can demonstrate problem solving skills on a 1 to 1 basis or group setting
- Strong analytical, research, and editing skills
- Work in a quality minded and productive manner exemplifying excellent organizational and communication skills
- Demonstrated ability to effectively communicate and interface with science and engineering technical management and staff\
- Strong organizational skills for maintenance of documentation and data
2
Skills For Quality Systems Supervisor Resume
- Strong time management and organizational skills necessary
- Demonstrated leadership skills, including the ability to develop and articulate a strategic plan and implement that plan across a cross functional team\
- Strong leadership skills for the ability to lead teams of a cross-functional and multi - level nature, including senior management representatives
- Effective communication, presentation and report writing skills
- Strong interpersonal skills, with the ability to build and maintain relationships
- Good computer skills
- Good communication skills
- Working knowledge of Good Manufacturing Practices (GMP) or other Good Regulated Practices (GxP’s) as they relate to Innomar activities
3
Skills For Quality Systems Technician Resume
- Experience in leading and applying effective organizational change management techniques within projects
- Knowledge/skills in Computer Programming languages, including SQL, VB, C# or C++ and PHP
- Three (3) years’ experience in pharmaceutical manufacturing chemistry lab or transferrable experience in a manufacturing role
- Participates in team decision making and displays problem solving/communication skills
- Demonstrated experience in making informed recommendations and decisions, and communicating across project disciplines\
- Experience supervising people or complex project management experience required
- Solid software proficiency in: MS Office, including PowerPoint, Excel and Word desired experience in Minitab
- Proficiency in basic office computer skills (email, word-processing and spreadsheet software)
- Proficient in computer skills, primarily Microsoft Office, including but not limited to Excel, Word, Visio, and Power Point
4
Skills For Quality Systems Associate Resume
- Highly organized self-starter with a strong attention to detailed including Good Documentation practices with drive and enthusiasm for quality
- Responsible for developing the quality team to improve team member’s skills and capabilities
- Interface effectively with IT and Test Engineering
- Direct the Corrective Action Preventive Action (CAPA) program and ensure CAPAs are being resolved effectively
- Communicate effectively across the three teams in the Analytical Group to ensure a high level of collaboration between groups on various topics, including EHS
5
Skills For Quality Systems & Compliance Manager Resume
- Basic knowledge of Good Manufacturing Practices and Good Documentation Practices required
- Demonstrated experience in conducting internal and supplier audits for ISO 9001
- Demonstrated experience working with various quality tools such as flow charts, check sheets, Ishikawa diagrams, Pareto charts etc
- Demonstrated experience performing Quality Assurance in an FDA-regulated medical device industry environment (knowledge of ISO 13485 and 21 CFR 820)
- Demonstrated experience in applying Lean Six Sigma tools and techniques \(Green Belt or Black Belt Certification\)\
- Skills in the usage of Microsoft Office (Word, Excel, etc.), Microsoft Access databases, Microsoft SharePoint, or Quality Database Management Systems
- Working experience with Computer System Validation (i.e., defining user requirements, functional testing and ERES compliance)
- Demonstrated experience leading/supervising associates to include technicians and/or analysts
- GXP experience - or equivalent training and/or experience
6
Skills For Specialist, Quality Systems Resume
- Computer skills and work processing, spreadsheet ad software capabilities
- Knowledge and skills in writing procedures and reports
- Effectively communicate and influence the outcomes of the decision making process
- A proven people leader capable of developing people and teams with at least 8 years of management experience
- Well established computer skills with database, spreadsheet, and word processing programs
- Six (6) years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is required
- Advanced computer skills with proficiency with Microsoft applications (Word, Excel, Visio) and Adobe Professional
7
Skills For Supervisor, Quality Systems Resume
- Experience in Pharmaceutical / Biotechnology industry with demonstrated Quality Systems responsibilities
- Effectively read, write and verbally communicate
- Advanced PC skills, including training and knowledge of Excel and database programs
- Strong operations support background ensuring value added and effective quality oversight
- Manage and maintain a Laboratory Information Management System (LIMS) to effectively manage samples and associated data throughout the analytical areas
- Prior experience with a food, water or pharmaceutical laboratory would be considered an asset
- An ability to collaborate across functional lines and work effectively in a team environment
- Ensure Good Documentation Practices are adhered to in line with current Good Manufacturing and distribution Practices (cGMDP)
8
Skills For Quality Systems Lead Resume
- Developing changes to procedures, to improve operation and user experience, while supporting the
- Publishing experience with newsletters and tutorials
- Working experience of quality or R&D in medical device/pharm/similar industry is not less than 5 years
- Experience in creating, implementing, maintaining, evaluating, enforcing and updating a facility’s GMPs, HACCP, SSOP and SOP’s and Quality programs
- + Experience in conducting and or designing systems-level evaluations which offer continuous learning opportunities for assessors and people being assessed
- Experience maintaining, administering, analyzing, and/or auditing Quality Systems?
- Experience leading projects with history of achieving results and outstanding outcomes
- Experience facilitating and leading risk assessments using risk management methods and tools
9
Skills For Analyst, Quality Systems Resume
- Review manufacturing and testing documentation, including validation/qualification, batch records, and other technical documents
- Assist with training new employees on the quality management system and maintaining accurate training records and metrics that provide evidence of completion
- Investigate ways of working improvements across the division such as CB consolidation, Auditor resource pooling, Standards documentation access etc
- Extensive experience with defining critical parameters and testing for equipment & facilities commissions and qualification
- + Experience assessing and improving quality-related processes and systems
- + Experience developing and subsequently executing business improvement solutions
- Experience managing and/or working within a Quality Management System
- Experience working with and educating senior management
- Experience in Documentation Management Systems concentrating on converting non-related systems into managed automated systems
10
Skills For Manager, Global Quality Systems Resume
- Experience designing and implementing policies, processes, and assessment methods to ensure adherence to quality requirements
- Experience of manufacturing operations and dealing with regulatory authorities is highly desirable
- Experience working with 3rd party auditors, external customers and managing internal controls
- Experience in quality or manufacturing setting
- Experience dealing with ISO quality systems (ex: auditing, documentation of ISO system)
List of Typical Responsibilities For a Quality Systems Resume
1
Responsibilities For Quality Systems Coordinator Resume
- EnsureknowledgeandpracticeoftheGroup’sQualitySystemsandProcedureswithinthePlant.In support of the quality system, provide effective leadership support, training and guidance to all company
- Demonstrated skills in executing/implementing projects
- Strong knowledge and proven experience with BRC, ISO9000 and ISO14000 is mandatory
- Good MS Office & SAP skills
- Detail-oriented with good organization and time management skills
- Strong organization & follow-up skills
- Excellent Microsoft Office skills (Word, Excel, Outlook, PowerPoint, and Visio)
- Team player with strong leadership and interpersonal skills
- Strong collaborative skills and customer service approach
2
Responsibilities For Quality Systems Supervisor Resume
- Good communication and negotiation skill with project team, Good quality influence power
- Strong computer skills (Excel, PowerPoint, SAP, Empower, LIMS, etc.)
- Skill to communicate effectively with all levels of the organization. Ability to thrive in a team environment
- Strong communication skills to influence, coach and develop a diverse work group
- Strong computer skills to create, analyze and abstract data from, reports
- Strong interpersonal skills with the ability to resolve issues professionally, quickly, and efficiently
- Proven leadership skills, with ability to influence and motivate cross-functional teams
3
Responsibilities For Quality Systems Technician Resume
- Knowledge/skills in the use of SPC software
- Knowledge/skills in the use of quality management software
- Knowledge/skills in Word, Excel and PowerPoint
- Knowledge/skills in Software application development
- Knowledge/skills in Database Administrator (DBA) for MS SQL and/or Oracle databases
- Shall be able to effectively prepare communications to the customers and management in a productive manner with clarity, brevity, and accuracy
- IS system or Quality experience is essential, preferably expertise in ‘validation’
- Demonstrated experience with investigational/problem solving tools (DMAIC, Lean) and project management
4
Responsibilities For Quality Systems Associate Resume
- PC skills including spreadsheets and specialized metrology software
- Experience in quality assurance, quality oversight or relevant experience
- Demonstrated ability to manage multiple projects and establish priorities
- Advance presentation and communication skills in English language
- Speak and collaborate effectively across multiple groups
- Multi task and manage time effectively
5
Responsibilities For Quality Systems & Compliance Manager Resume
- Demonstrated ability to plan and prioritize time and meet deadlines
- Experience in quality assurance, quality oversight or relevant experience
- Proficiency with basic computer skills, including Outlook, Word, Excel, etc
- + Proven history of leadership and change management \(such as mentoring, coaching, partnering, and networking\)
- + Experience developing and subsequently executing business improvement solutions\
- Experience in food, dietary supplement or other relevant FDA regulated product manufacturing
- + Experience and knowledge of work planning and control criteria for safe design and operations at the activity work level\
- Prior work with IVDs, molecular diagnostics, PCR-based assays, and/or sequencing technologies
- + Experience with implementing Quality Management Systems (e.g., ISO 9001:2008, ISO 14001, AS9100, and DOE O 414.1D) and Quality Systems audit practices
6
Responsibilities For Specialist, Quality Systems Resume
- + Experience applying quality practices within the context of R&D, production, and service areas across diverse business units
- Experience working with UK Multiples
- Three (3) to five (5) years’ experience in a cGMP environment
- Transmit procedures related to quality effectiveness (quality walls, PokaYoke, autoquality, etc.) to the entire site,
- 5+ yrs industry experience in a medical device-manufacturing or pharmaceutical environment
- Experience working with EQMS software would be a distinct advantage
- Experience within a role in quality systems in a regulated industry
- Experience with the software development cycle
7
Responsibilities For Supervisor, Quality Systems Resume
- Coordinate responses to Customer Surveys. Maintain archive of prior surveys and FAQs
- Operate in a high paced environment
- Work with a sense of urgency to meet deadlines, schedules, personnel issues, and manage multiple priorities
- Strong knowledge of English, both written and verbal
- Strong knowledge of TS16949, ISO14001, Customer Specific Requirements, and Core Tools
- Experience and working knowledge of quality management systems (ex. SAP, EtQ, Compliance, EDM & Tru, and Docspace) is required
- Relevant professional experience (in a production environment, in Quality field)
- Assure that procedures and work instructions are implemented, adhered to, effective, efficient, and not redundant
8
Responsibilities For Quality Systems Lead Resume
- Works with IT and Quality Systems owners to maintain the applications, design and implement system improvements, and support Quality System validation efforts
- Functions as HACCP team leader, lead team in hazard analysis, HACCP plan development, verification and validation
- Investigates deviations against the lot documentation and records issuance system and develops effective corrective action plans
- Review of Draft SOPs, BMRs, Protocols, Methods, Specifications, Validation reports and Master documents
- Verify plant quality and food safety programs and practices are in place, effective and compliant (QMS review)
- Supports implementation of compliant and effective Document Control system
- Support for MasterControl Software Updates and validation where required
- Rapidly adapt priorities and respond to changes in a fast-paced environment in order to meet deadlines
9
Responsibilities For Analyst, Quality Systems Resume
- Lead cross-functional meetings & facilitate teams as needed in the preparation and execution of effective quality audits and layered process audits (LPAs)
- Proficient in the use of a computer, MSOffice suite knowledge/experience
- Lead and provide support to continuous improvement initiatives within the Quality Compliance Department through effective review and analysis of information
- Excellent attention to detail and quality mindset are essential
- Experience executing and/ or reviewing investigations, CAPA’s, and Change Controls is required
- Demonstrated understanding of quality management in an FDA regulated environment
10
Responsibilities For Manager, Global Quality Systems Resume
- Experience working on cross-functional, and global teams
- System engineering/program management experience
- Experience developing presentations for senior managers and staff
- In the Healthcare sector with 4-5 years’ experience in a similar or equivalent role, working across site and corporate structures
- Good working knowledge of cGMP, USP/EP, ICH and FDA guidelines is necessary
- Experience in a quality and/or manufacturing environment in the medical device industry
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