QA Auditor Resume Sample
Samanta Mraz
4742 Hahn Streets,
San Francisco,
CA
+1 (555) 607 6880
Work Experience
Senior QA Auditor
11/2015
-
PRESENT
Dallas, TX
- Communicates with loaders and loader foreman about which truck to unload next
- Unloads all returns and properly disperses and stores product in an organized manner
- Informs foreman or supervisor of any large quantity returns
- Logs and throws away any leaking returns
- Unloads all totes and freezer boxes and stores in the proper location
- Unloads and separates all empty pallets and stores in the pallet staging area
- Checks with supervisors or manager at the beginning of the shift to discuss any issues or changes in the daily procedure. Checks E-mail daily for schedule changes, additions, promos, etc
- Assists in the training of and monitoring of all staff to ensure accurate and efficient order selection, pallet building and replenishment
- Travel 50% +
QA Auditor
02/2012
-
07/2015
Detroit, MI
- Conduct external supplier audits
- Provide oversight of the Corporate Supplier Management plan, Audit & Reevaluation schedule
- Knowledge of applicable Quality Standards, related Regulatory requirements and best practices
- Understanding both receiving site and supplier procedures and practices
- Adherence to timelines regarding availability of audit reports and other critical documents
- Act as the liaison between Suppliers in their region and the Patheon internal sites
- Collaborate with site management and global/site Procurement teams
- Ensure that CAPAs are formally recorded and reported and that corrective/preventive actions are documented and followed until resolution.
Chemistry QA Auditor
10/2006
-
09/2011
Philadelphia, PA
- Travel (approximately 5-10%) domestic and/or international
- Demonstrate creativity and astute thinking
- Internal: Frequent contact with managers, supervisors and co-workers. 60% Operations; 20% Lean Systems, 20% Supply Chain
- External: Periodic contact with regulatory entities and technical, industry and government related representatives. Occasional contact with contract customer and supplier quality units
- Conducts and/or leads a variety of client, internal or GMP audits and regulatory inspections as requested by senior management
- Occasionally lift/carry/move up to 50 pounds
- Complete periodic testing plans related to Loss Analysis identified break points
Education
Utah State University Eastern - Price Campus
2001 - 2006
Bachelor's Degree in Science
Professional Skills
- Strong interpersonal skills needed (e.g., listening, negotiation, decision making, assertiveness)
- Strong analytical capacity, organizational skills, critical thinking and problem-solving abilities
- Experience applying knowledge of process validation, method validation and sterilization processes
- Good IT skills, experience in word, excel, powerpoint
- Persuasively communicate using excellent written and verbal skills
- Strong collaboration and communication skills required. Ability to multitask and
- Excellent interpersonal skills, professional attitude, with the ability to produce consistently high quality work
How to write QA Auditor Resume
QA Auditor role is responsible for training, microsoft, manufacturing, software, computer, analytical, research, credit, database, procurement.
To write great resume for qa auditor job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QA Auditor Resume
The section contact information is important in your qa auditor 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 QA Auditor Resume
The section work experience is an essential part of your qa auditor 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 qa auditor responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qa auditor position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QA Auditor resume experience can include:
- Prior experience in data entry auditing role within a managed care, provider claims, provider contract or other healthcare related industry
- Development of management and supervisory skills through execution of managerial responsibilities as needed
- Microsoft Office skills required (intermediate)
- Auditing experience in GMP environment – 2 to 3 years on auditing team required
- Responsible for recording capturing, analyzing and storing visual evidence related evaluation criteria
- Demonstrate ability to be detail-oriented as it relates to reviewing/researching and determining appropriate conclusions
Education on a QA Auditor Resume
Make sure to make education a priority on your qa auditor resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa auditor 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 QA Auditor Resume
When listing skills on your qa auditor 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 qa auditor skills:
- Organizational skills, detail-oriented, multi-tasking and prioritization skills
- Good analytical reasoning / maths skills
- Possesses sound reasoning and problem-solving skills
- Good attention to detail and good auditing practices
- Previous experience working in a similar role (FMCG experience advantageous)
- Relationship skills to build and maintain a positive relationship with senior leaders
List of Typical Experience For a QA Auditor Resume
1
Experience For Senior QA Auditor Resume
- GCP auditing experience
- Integrity to objectively evaluate and report on process effectiveness
- Prioritize tasks and execute on multiple workstreams across diverse subject areas
- Provide a benchmark of auditing competencies to inexperienced colleagues.
- Experience in a regulated medical industry (Pharmaceutical, CRO and/or CMO)
2
Experience For QA Auditor Manager Resume
- Researches and demonstrates understanding of global standards, regulations and regulatory bodies
- Related industry experience in an analytical laboratory
- Train QA auditors, and provide a benchmark of auditing competencies to less experienced colleagues
- Ensure that GMP validation reports are audited and approved in accordance with the agreed project schedule
- Good commercial awareness and customer focus
- Background in medicine, science and/ or other relevant discipline and appropriate experience
- Place ingredients and finished goods on hold, as directed by the QA Manager/QA Team Leader
3
Experience For Senior QA Auditor / Risk Adjustment Resume
- Performing and reporting study specific audits in both procedures and report texts while working closely with Study Directors
- Identifying non-compliance with procedures and regulatory requirements; identifying / resolving any necessary amendments
- Assisting in audit preparation, system analysis and training
- Reviewing and approving deviation, investigations, and corrective and preventive action that is associated with analytical laboratories
- Advising management of QA trends via reports to QA management
- Handling all quality and food safety production holds and product release
- Understanding of Acidified Foods and compliance to all federal guidelines
- Understanding of compliance to all federal guidelines
- Willing and capable to remotely collaborate with a diverse number of Hilton multi-disciplinary teams
4
Experience For GCP QA Auditor Resume
- Advising scientists on best practises for document completion, review and follow up actions
- Perform QA tasks including product sampling, line monitoring, auditing, lab testing and calibrations to ensure compliance to specifications
- Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for
- Follow testing script requirements without deviating or creating inconsistencies
- Participate in managing the recording, investigation, tracking and resolution of any Quality Issues
- Assist with meeting content preparation, training and with projects as needed
- Test and confirm that the components are passing/failing batch information and product properly
5
Experience For QA Auditor Team Lead Resume
- Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance
- Responsible for gathering estimate data and auditing based on modern construction practices, contractor instructions and knowledge of Xactimate
- Develop department training using data gathered in the quality assurance process(s)
- Advanced knowledge of the water restoration industry to allow for evaluating proper drying techniques, equipment usage and demolition/salvage determination
- Responsible for Understanding and Monitoring HACCP, SSOP and GMP program implementation in the facility
6
Experience For Chemistry QA Auditor Resume
- Responsibilities include maintaining archives and managing workflow of the paperwork
- Assist with business development activities, including the preparation of cost proposals/contracts, and attend marketing presentation, when appropriate
- Has the ability to interpret regulations and communicate clearly, both verbally and in writing, the finding and how it does not comply with the regulation
- Follow sampling plans and standard operating procedures
- Assist in training ICON staff regarding GCP, ISO 9000, role of QA, regulatory inspections etc
- Audit laboratory testing, analytical test methods and protocols for Compliance with Standard Operating Procedure and Quality Assurance Agreement
- Review and audit of microbiological testing and sanitation cleaning inspection reports
- Monitors and audits product and processes from receiving through shipping to ensure all food safety and quality requirements are met
- Knowledge of hotel development process including financing, construction and operations
7
Experience For Manager, QA Auditor Resume
- PowerPoint (creating and editing presentations)
- Constructively deal with change and pressure. Willing to continue training/ education as necessary
- Identify opportunities for conversion of testing from manual to leverage automation
- Discretion of when to seek assistance or escalate issues where testing criteria appear illogical
- Perform scheduled line checks which include verifying the correct conformance of parts
- Examine and verify that the packaging meets quality standards
8
Experience For Principal / Senior QA Auditor Resume
- Knowledge of auditing product
- Ensures compliance to Regulatory, Division, Site and Corporate policies and procedures by promptly reporting non-compliance issues
- Provide expertise audit support to the division in preparation for and during external audits
- Utilizes expertise and audit intelligence during audits. Provides advice or recommendations for compliant and strategic solutions to complex quality issues
- Assist QA management in the development and implementation of procedures and working practices to ensure continuous quality improvement
9
Experience For QA Auditor, Out of Network Medical Claims Resume
- Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested
- Reviews, optimizes, maintains and manages the error logging process
- Advanced understanding and comprehension of multiple network programs, guidelines and requirements
- Responsible for performing daily record reviews to ensure all quality and regulatory requirements are met
- Identify OOS and deviations in analytical results and dealing with any non-conformances
10
Experience For Senior QA Auditor, GCP Resume
- Audits outgoing product count to ensure order is complete and accounted for in the system
- Monthly Audit Reports (Reporting all factory activities)
- Assist in training new QA auditors
- To assist Sales staff in client discussions and in the issuing of requested documentation
- To act as an independent compliance monitor during study inspections of client-sponsored and in-house studies
- Review data and direct follow-up of product testing deviations and trends to meet customer requirements
List of Typical Skills For a QA Auditor Resume
1
Skills For Senior QA Auditor Resume
- Good of workload prioritisation skills, decision-making and scheduling skills
- Experience demonstrating analytical thinking, problem-solving, and critical thinking skills
- Good organisational & planning skills
- PC skills to include strong knowledge of Windows operating system, and applications to include Microsoft Word and Excel
- Strong skills with Microsoft Programs: Excel, PowerPoint, Word
- Excellent written and verbal communication skills, which include the ability to clearly and accurately communicate findings
- Has excellent coordination and communication skills
- Experience with leading and performing effective audits and obtaining meaningful audit observations
2
Skills For QA Auditor Manager Resume
- Experience: Entry level - 0+ year experience
- Good experience in QA / GMP role within the pharmaceutical industry
- Effectively liaises with other QA staff in preparation for hosting client
- Communicates effectively to internal and external customers
- Strong experience with warehouse environment and logistics operations
3
Skills For Senior QA Auditor / Risk Adjustment Resume
- Understanding of how to interpret microbiological methods and method validation
- Experience in Microsoft Office suite of applications including Excel (sorting, filtering)
- Responsible for leading teams, when necessary, and mentoring and coaching new or inexperienced colleagues as needed to meet the business needs
- Skilled in working with numbers for counting quantities of outgoing products
- Excellent working knowledge with the following software programs: Microsoft Office (Excel, Word, PowerPoint, Access)
- Skillful in problem solving and analytical thinking
- Experience using MS Excel features that include formats, macros, and creating pivot tables
- Experience in a food-processing, pharmaceutical or chemical manufacturing industry
- Assist in the development of departmental policies and procedures; review the effectiveness of existing training
4
Skills For GCP QA Auditor Resume
- Experience working with servicing, operational risk, or compliance within the mortgage industry
- Experience in managing various hotels at a time
- Previous experience working in a highly regulated environment
- Experience working with internal or external partners to drive compliance, CAPA completion to audit findings, and/or performance improvement is required
- Experience analyzing medical claims
- PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to
- Experience with quality auditing and review for lab operations
- Validate the accuracy of the data elements on letters
- Demonstrate the ability to anticipate and plan
5
Skills For QA Auditor Team Lead Resume
- Manage multiple priorities and follow up on work in various stages of completion
- Prepare and review Quality Assurance files prior to Sponsor site visits
- Maintain the QRQC program and report regularly on its effectiveness
- Identifies and presents evidence of quality and compliance risks to QA Management as they appear
- Demonstrate drive and results orientation
- Demonstrate teamwork and develop cross-functional cooperation
- Good working knowledge of SOPs, GMPs, and cGMP’s applicable to Quality Operations, Manufacturing and Packaging
6
Skills For Chemistry QA Auditor Resume
- Experience creating presentations in Microsoft PowerPoint and conducting presentations
- Min. 3 years Lab experience utilising Chemistry techniques and Empower software
- One (1) year relevant experience in Quality Control, Quality Assurance, Product Development or Production
- Proficiency with computer systems, specifically demonstrated knowledge of Oracle, Trackwise, LIMS and/or cMe/SQA
- Highly motivated individual with initiative and strong attention to detail
- Experience with MS Excel with concentration on advanced formulas (i.e. v-lookups), Macros, and pivot tables, SharePoint
7
Skills For Manager, QA Auditor Resume
- Experience in data review/qc review/peer review essential
- Three (3) years of experience as a Department Head in a Hotel
- Two (2) years of management experience
- Experience in a Focused Service or Full Service hotel
- Residential mortgage operations/compliance experience
- Experience in CAPA management systems (i.e. TrackWise)
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
8
Skills For Principal / Senior QA Auditor Resume
- Investigate the critical phases of all preclinical studies re method validation, sample analysis for compliance with study plans,
- Effective at analyzing problems considering the ‘big picture’ and recommending
- Experience with FDA QSR Quality System Regulation and/or FDA 210, 211
- Experience in design controls, 510ks submissions, or CE file development
- Experience in CAPA (Corrective and Preventive Actions) management
- Experience in Microsoft Excel - beginner to intermediate level
9
Skills For QA Auditor, Out of Network Medical Claims Resume
- Operate powered equipment
- Operate normal laboratory equipment
- Has a good knowledge of Word and Excel
- Direct audit experience in GCP required
- Xactimate Level 2 Certification or equivalent experience
- Review laboratory testing to ensure GMP procedures are followed (e.g, Good Documentation practices, laboratory cleaning practices)
- Excellent time management and planning abilities
10
Skills For Senior QA Auditor, GCP Resume
- Deliver effective food safety and food quality training for facility team members
- Assist with audit follow to ensure implementation and effectiveness of corrective actions
- Related experience and/or training is required
- Operate independently and self-manage workload to ensure required testing volume is achieved
- Extensive experience in Quality Assurance auditing
- Provide a benchmark of auditing competencies to inexperienced colleagues
List of Typical Responsibilities For a QA Auditor Resume
1
Responsibilities For Senior QA Auditor Resume
- Make sound decisions about scheduling, allocation of resources, and managing priorities to meet business objectives
- Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; ISO14971; IVDR; MDR; etc
- Knowledge of the outcomes of prior audit activities of the client
- Experience with Promise Land and LCS
- Experience with internal GMP audits and vendor audits beneficial
2
Responsibilities For QA Auditor Manager Resume
- Demonstrate high moral character and ethics. Adheres to company codes of conduct
- Willing to travel up to 50% of the time for business purposes (within state, out of state and/or internationally)
- Focus on standardizing all operations in the interest of improving the operating compliance and performance standards
- Provide regulatory training (QSR, GMP, auditor training, Audit readiness among others)
- Recognizes specific areas for improvement in the audit programs Completes assigned activities for hosting of client audits/visits , CAPA tracking
- Assist in training ICON staff regarding GCP, ISO 9000, role of QA, regulatory audits etc
3
Responsibilities For Senior QA Auditor / Risk Adjustment Resume
- Comfortable working in Warehouse/Distribution setting
- Develop risk based audit planning focusing on medical care of patients and adherence to protocols and GCPs for global clinical site audits
- Make sure there are written and signed records of auditing activities
- Review data from environmental monitoring of controlled areas
- Observe integrity testing of product filters
4
Responsibilities For GCP QA Auditor Resume
- Approve issued product identification cards for use in filling
- Knowledge mortgage servicing investor, federal and state requirements
- Integrate regulatory, compliance, quality issues into audit and assesssment planning processes, based on risk
- Responsible for working with QA management, department personnel and other areas on process reviews and implementation of requirements in compliance programs
- Review and approve Standard Operating procedures, Analytical Methods, and other Operations related documentation
- Provide ongoing QA guidance and oversight in relation to shutdown activities for the Seattle operations
5
Responsibilities For QA Auditor Team Lead Resume
- Manage audit backroom during external audits
- Licenciature: Electronic, Biotechnology, Electromechaical Engineering or related field
- Participates in setting goals and objectives for the QMS and audit program functions
- Perform testing and inspection for out-sourced products when needed
- Assist in training of new auditors when necessary
- Work with Word and Excel software in preparing reports
- Support in researching root cause analysis on observed operational breaks
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the
- To support, assist in the management and reporting of any deviations, corrective actions and investigations to the management of SGS
6
Responsibilities For Chemistry QA Auditor Resume
- Read, write and interpret documents such as protocols, safety rules, operating and maintenance instructions and procedure manuals
- Maintain and promote a quality culture through training
- Coordinate timely hold and disposition of raw ingredients, packaging materials and finished product
- Ensure that systematic issues raised during billable audits are escalated and addressed
- Develop and optimize new and existing processes to maintain and improve quality within QA and billable QA activities
- Supports and adheres to all company safety rules and programs to provide safe working conditions for all associates
- Assists in maintaining database of required lab data
- Verifies that process controls, weight control, HACCP and finished product specifications are adhered to by regularly auditing procedures and paperwork
7
Responsibilities For Manager, QA Auditor Resume
- Track QC testing and QA investigation and release process, and report regularly to the Value Stream
- Perform internal GMP audits and monitor resulting corrective actions
- Investigate product complaints, ensuring a timely, complete response
- Contributes annually to the development of the 3-year Quality plan, providing recommendations for appropriate plans and resources
- Recognize, exemplify and adhere to ICON's values which centres around our commitment to People, Clients and Performance.
- Travel (approximately 35%) domestic and/or international.
- Be knowledgeable with all relevant ICON SOPs, ISO 9000 requirements and with appropriate regulations and guidelines.
8
Responsibilities For Principal / Senior QA Auditor Resume
- Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.
- Assist in training new AQ auditors.
- Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
- Assist with the development of the project audit procedures.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
- Present educational programs and provide guidance to operational staff on compliance procedures
- Execute program steps through transaction testing and observation of operating activities in compliance with Brink’s standards; remain alert to changing situations, demonstrate flexibility and adaptability in difficult circumstances and continuously strive to achieve a result
- Review and ensure compliance with the systems, procedures, rules, objectives and timescales set by the organization (Brink’s Policy and Procedures and local key regulatory requirements)
- Travelling up to 20% (national/international)
9
Responsibilities For QA Auditor, Out of Network Medical Claims Resume
- Perform GMP, documentation and technical training of hourly and supervisory VS workforce
- Perform Quality Assurance activities within the scope of the assigned Value Stream
- .Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor
- Maintain all associated department spreadsheets, tracking of audit findings, and audit files as applicable
- Assists senior staff during regulatory inspections
- Serve as a resource regarding interpretation and application of quality requirements, concepts, and industry best practices within Akebia
- Prepares required documentation to support audit activities including; audit plans, audit reports, audit certificates and corrective action plans
- Represents QA department at internal and external meetings supporting clinical programs
10
Responsibilities For Senior QA Auditor, GCP Resume
- Assure Corporate compliance with SOPs and GCP regulations
- Independently schedule, plan, coordinate and conduct internal system, supplier, and clinical trial site audits
- Read, understand, interpret, and apply regulations, guidance documents, and study protocols requirements to clinical studies
- Assist in development and implementation of pre-approval inspection readiness plans at investigative sites
- Audit toxicology study plans, reports, raw data re completeness, accuracy and GLP compliance
- Attend an average of 4 necropsies procedures per month
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