Specialist Quality Assurance Resume Sample
Marty Huel
870 Metz Terrace,
Chicago,
IL
+1 (555) 985 5164
Work Experience
Specialist Quality Assurance
01/2018
-
PRESENT
New York, NY
- Reviews current processes, assuring any changes are given to management, for the creation and updating of training manuals and other training material.
- Works as a team member on shop floor audits, quality systems activities and/or process improvement projects
- Assures consistent application of standardized work, process tools, and procedures
- Assists with regulatory inspections in either documentation area, request management area or inspection room
- Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation
- Industrial experiences are beneficial
- Profound organisational and communicational skills coupled with assertivness
- Good understanding of customers and regulatory quality requirements
Principal Specialist, Quality Assurance
10/2013
-
10/2017
Detroit, MI
- Strong interpersonal skills, effective teamplayer
- Proficient Microsoft Office applications including Word, Power Point and Excel
- Fluency in both languages German and English
- Provides sound quality guidance to all groups and ensures each decision maintains the Safety, Quality, Integrity, Potency, and Purity (SQuIPP) of Celgene products and components
- Adopts and constantly utilizes Quality Risk Management principles to make sound quality decisions
- Ensures the site meets all regulatory standards and consistently produces GMP compliant product
- Complete evaluation scorecards for recorded telephone conversations and/or applicable research functions
Specialist Quality Assurance Call Centerus
03/2011
-
09/2013
Los Angeles, CA
- Extract reports from online vendor tool, analyze data and summarize information contained within the reports and disseminate accordingly
- Escalate “quality alerts (defects detected during call monitoring)” to the Customer Service Representative/SPOC Case Manager/Collections Representative and Customer Service/SPOC/Collections leadership
- Identify trends and escalate to appropriate parties
- Coordinate and lead joint call monitoring sessions
- Coach and train representatives on procedural changes and process updates
- Ensure contractual obligations regarding call monitoring are met
- Complete monthly reporting assignments where appropriate
- Review and validate deficiencies with senior leaders
Education
Kaplan University
2005 - 2010
Bachelor's Degree in Microbiology
Professional Skills
- Strong communication skills, (both written and oral), facilitation and presentation skills
- Strong leadership skills and analysis and a highly creative
- Excellent interpersonal skills, organization and time management
- Strong organizational skills and ability to manage multiple tasks at one time
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
- Experience working with dynamic cross-functional teams and proven abilities in decision-making
- Demonstrated leadership and proven ability to mobilize internal and external partners
How to write Specialist Quality Assurance Resume
Specialist Quality Assurance role is responsible for leadership, general, finance, credit, training, integration, database, auditing, java, architecture.
To write great resume for specialist quality assurance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Specialist Quality Assurance Resume
The section contact information is important in your specialist quality assurance 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 Specialist Quality Assurance Resume
The section work experience is an essential part of your specialist quality assurance 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 specialist quality assurance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular specialist quality assurance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Specialist Quality Assurance resume experience can include:
- Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing
- Responsible for EO sterilization process annual revalidations and quarterly gamma dose audit testing according to ANSI/AAMI/ISO standards
- Facilitate Quality Risk Assessments (from planning to report issuance) towards effective implementation of process/product/system changes
- Experience manual testing in custom built business applications
- Automated or performance testing experience is an asset
- Responsible for coordinating activities associated with sterilization process R&D, optimization, and validation, as assigned
Education on a Specialist Quality Assurance Resume
Make sure to make education a priority on your specialist quality assurance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your specialist quality assurance 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 Specialist Quality Assurance Resume
When listing skills on your specialist quality assurance 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 specialist quality assurance skills:
- Demonstrated analytical aptitude, critical thinking skills and problem solving skills
- Leadership skills, experience working within cross-functional teams, and ability to handle multiple assignments simultaneously in a fast paced environment
- Proven experience in managing multiple priorities simultaneously and meeting deadlines
- Excellent leadership and teamwork skills, including collaboration and ability to identify and drive continuous improvement
- Strong SQL skills are required to be successful in this role
- Assist in the execution of in-house validation programs as it pertains to the stability software validation
List of Typical Experience For a Specialist Quality Assurance Resume
1
Experience For Principal Specialist, Quality Assurance Resume
- Practice (cGMP), Good Distribution Practices (GDP) and other applicable regulations
- Professional experience within an FDA regulated industry, preferably medical devices
- Auditor experience in sterilization
- Experience in a GMP regulated facility or laboratory
- Internship or Co-op experience with Merck
- Prefers at least two years of experience in a high volume call center as either an agent or in a managerial capacity
- Knowledge of and experience of fabrication processes for mechanical and process equipment
- Experience within QA in the Pharma industry
- Analyzing product complaint data, detecting signals, identifying root causes and corrective actions
2
Experience For Associate Specialist, Quality Assurance Resume
- Establishing investigation requirements for product complaints investigations
- Training for staff on quality system processes
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
- Review deficiencies with leadership, legal, and the client, ensuring all deficiencies are remediated
- Ensure that changes that could potentially impact product quality are assessed according to procedures
- Complete assigned training to permit execution of required tasks
- Generate monthly metrics for product quality teams, trending, and management review
- Perform product complaint quality auditing
3
Experience For Specialist Quality Assurance Call Centerus Resume
- Advances technical expertise by performing advanced work assignments
- In-depth understanding of ISO 11135 and 11137
- Provide updates to senior leadership including metrics at Management Review
- Responsible for ensuring raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements
- Track record of success in international working environment
- Verify borrowers who are in foreclosure/bankruptcy/cease and desist/litigation are contacted appropriately and recorded/reported accordingly
4
Experience For Associate Specialist Quality Assurance Resume
- Conduct quality assurance/quality control audits (QA/QC) of multiple Special Loans/ARMs functions, memorialize and distribute audit findings
- Maintain logs/database of team’s output
- Support fulfillment of audit requests received from investors, regulators and clients
- Provide insight for the development of QA/QC policies and procedures and ensure full understanding of all policies, procedures and investor, regulator and client guidelines
- Review and approve Standard Operating Procedures (SOP) ensuring SOP’s reflect accurate working practices, documents are logical and are technically sound
5
Experience For Specialist, Quality Assurance Analyst Resume
- Raise CAPA’s ensuring they are appropriate and approve on closure
- Responsible of QRM metric reporting as per schedule
- Act as QA contact for Non-conformances and CAPA’s
- Site liaison for QRM issues and provide input on opportunities for improvements and waste reduction to the system at QRA network meetings
- Own and maintain site Quality Risk register
6
Experience For Senior Solution Specialist Quality Assurance Resume
- Support the change control program, with hands on ownership for QA/QC change control records and resolution of issues towards successful implementation of the change
- Oversee and review data to ensure all site commitments are met timely and in a compliance fashion
- Perform comprehensive Quality review of documentation / data to support commitment closure
- Ensure compliance of areas of responsibility
- Interface with Senior Management, auditors and regulators
- Ensure facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations
7
Experience For Associate Specialist Quality Assurance Systems Resume
- Ensure raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements
- Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations
- Ensure that deviations from established procedures are immediately triaged, investigated and documented per procedures
- Ensure that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
- Alert senior management of significant quality, compliance, supply and safety risks
- Perform AQL for Visual Inspection
- Release of gases, cell banks and labels
- Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
8
Experience For VP-specialist, Quality Assurance / QA Testing Resume
- Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations
- Ensure that deviations from established procedures are investigated and documented per procedures
- Alert senior management of quality, compliance, supply and safety risks
- Lead/support cross-functional task force to improve the quality of Amgen’s products
- Establish and/or revise product complaint procedures and work instructions
- Conduct product complaint investigations and assessments
- Develops and applies advanced concepts, principles, and technical capabilities to perform complex technical tasks and analyses
- Works on projects of significant scope and complexity
- Develops procedures and processes to resolve difficult and complex technical problems
9
Experience For PFS Specialist Quality Assurance PBO Patient Accounting Resume
- Provides guidance and direction to more junior departmental team mates
- Work experience specifically with terminal sterilization of medical devices, including with ethylene oxide, gamma radiation, steam, and electron beam modalities
- Applies knowledge of quality systems and tools to validate and verify contractually required standards for project execution. Implements principles of performance evaluation and prediction methods are used to improve product systems safety, reliability, and maintainability
- Under general direction, uses specialized knowledge or skills to solve complex and unique problems, or direct the daily activities of a business, technical support, or functional support team
- Perform all activities in compliance with Amgen safety standards, SOP’s and Quality System Requirements
- Ensure that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations
- Actively Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control, Self-Inspection and Investigations) and provide active input into shaping the future direction of these systems
- Review and approval of Investigations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
10
Experience For Solution Specialist Quality Assurance Resume
- Provide training and advice to staff in order for them to perform their desired functions
- Responsible for Quality Disposition (approval or rejection) of raw material and components, bulk drug substances, bulk drug products, and finished product for assigned areas, in a clinical and commercial setting
- Perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Investigations, CAPA’s and Change Control records
- Ensure that production records and testing results are complete, accurate, and documented according to written procedure and cGMP requirements
- Ensure that deviations from established procedures are investigated and document per procedure
- Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
List of Typical Skills For a Specialist Quality Assurance Resume
1
Skills For Principal Specialist, Quality Assurance Resume
- Data analysis process. Experience on Green belt, and problem solving
- Three to five years of management experience in a call center (customer service)
- Participate in and contribute to team meetings such as project team meetings, validation team meetings, etc
- Experience as a Test Lead on large or multiple projects
- Certification in Software Quality (American Society for Quality - Certified Software Quality Engineer) or equivalent experience
- Evaluate product design and proposed product changes for impact to the validated sterilization process and determine/manage required support testing
- Ensuring compliance with regulations as well as internal procedures
2
Skills For Associate Specialist, Quality Assurance Resume
- Support all related patching activities, perform post-patching testing to mitigate vulnerabilities
- Contributes to the performance and results of a vaccine manufacturing department
- Knowledge of tool for the processing of data: Jump, Minitab, Infinity, Excel
- Automate repetitive or high volume manual test cases to increase testing efficiency and minimize test cycle durations
- Automate execution of test cycles and reporting of results
3
Skills For Specialist Quality Assurance Call Centerus Resume
- Design/Develop automated test scripts based on complex manual tests to improve the productivity of the testing team
- Design and develop automation framework for complex systems involving end to end business scenarios
- Devise and develop new innovative automation ideas on new initiatives developed using agile methodology
- Perform data entry of test results into stability tracking software
- Communicate with the manufacturers and 3rd party laboratories as it pertains to the testing of product
4
Skills For Associate Specialist Quality Assurance Resume
- Perform monthly and annual trending of stability test results
- Assist manufacturer/vendor with investigating OOS results
- Interact with internal stakeholders to assist in ensuring compliance with internal procedures
- Certification in one of the following disciplines is an asset
- Responsible for the supplier management of contract sterilizers and testing support laboratories (internal and external)
- Lead supplier audits of contract sterilizers and sterility testing support laboratories
- Assists technical leaders with establishing sterilization strategy direction for the organization
- Provides regulatory, quality and compliance guidance
- Statistical analysis of the data and tool (SPC, CPK, )
5
Skills For Specialist, Quality Assurance Analyst Resume
- Medical Devices Quality System
- Support QA Tools & Dev Tools activities on daily basis
- Manage access requests for all Dev & QA tools
- Perform periodic upgrades to Dev & QA tools to maintain the latest versions
- Capacity of persuasion and motivation
- Juggle multiple tasks in a fast paced environment and act with alacrity
- Positive contribution to the organization, both individually and within a team
6
Skills For Senior Solution Specialist Quality Assurance Resume
- Thorough knowledge of processes and tools Client Services
- Knowledge of tools and procedures, services and products, an asset
- Ensure Quality Agreements are signed with each manufacturer/vendor and ensure compliance to the agreement
- Proactively identify, investigate and make recommendations within the position’s scope of responsibilities, effectively communicating on a timely basis to the Manager, Quality Assurance and Regulatory Compliance
- Develop, review and implement QA department procedures as well as assist with reviewing procedures for other groups
- As they relate to regulatory compliance and the position’s scope of responsibility
7
Skills For Associate Specialist Quality Assurance Systems Resume
- Assist/support all corporate or agency inspections, as required
- Familiarity in one or more than one of the technologies of networking, database, SAP and/or web technologies such as HTML, JavaScript, JSP, ASP, ABAP, .NET, MQ, Oracle and SQL Queries during test execution
- Experience with CP business applications is an asset
- Support review of sterilization batch records and the release of Ethylene Oxide (EO) and gamma radiation sterilized loads
- Responsible for sterilization deviation management
- Design and performance of EO sterilization process development, chamber qualification, process equivalencies, and implementation activities across contract sterilizers
8
Skills For VP-specialist, Quality Assurance / QA Testing Resume
- Authoring and technical expert review of study protocols/final reports and data verification
- Responsible for leading and executing assigned activities associated with advanced technical projects (complaint investigation, regulatory compliance, cost savings, etc.), as assigned
- Authoring of procedure, policy, and form updates and maintenance within quality system
- Provide technical expert support for product sterility testing, bioburden and environmental monitoring method development/validation, testing and trending, dose determination, and biological indicators
- Working knowledge of DevOps tools like GIT, Team City, Artifactory, Docker, Jenkins, SVN etc
- Support of employee training processes within the Sterility Assurance Department
- Certification in one of the following disciplines
- Manage and coordinate day to day testing activities at the project team level. Coordinate setup of test environments and test data management
9
Skills For PFS Specialist Quality Assurance PBO Patient Accounting Resume
- Responsible for multiple departmental programs
- Elicit requirements from the development, functional test and/or business teams want as input to the design, development, execution and maintenance of effective automation test scripts using HP UFT or an equivalent automation tool for the applications or systems under test
- Build automations test strategies and test frameworks based on the planned scope
- Maintain existing or newly built automation test scripts for ongoing changes and maintenance to applications under test. Manage the storage, scheduling and execution of automation test scripts including tracking any issues and defects within HP ALM
- Review results of the tests with various IS teams and clarify any observations. Make recommendations as required to improve the quality
- Provide thought leadership on the use of Quality Assurance automation testing tools and processes to ensure CP delivers the highest possible quality software aligned with IT industry best practices
10
Skills For Solution Specialist Quality Assurance Resume
- Hands on experience on HP ALM/Jira administration
- Evaluate business software and/or system requirements to ensure they can be translated into both functional and non-functional tests. Understand the business future state including the existing software/system’s capabilities along with any interfacing systems and the planned enhancements being made to both
- Translate the business software / system requirements into detailed test cases and test sets and record them using HP ALM test management tool. Identify and create data required to execute test cases
- Communicate and collaborate effectively in group (with technical and senior management staff) or one-or-one settings
- Demonstrated experience in quality assurance, quality systems, mainly Quality Risk Management and Change Control Process
- Experience leading and supporting cross-functional teams, and the ability to handle multiple product simultaneously
- Knowledge of and experience working with equipment specifications
- Aseptic processing experience (i.e. Environmental qualification, Media fills)
- Previous experience leading projects or teams
List of Typical Responsibilities For a Specialist Quality Assurance Resume
1
Responsibilities For Principal Specialist, Quality Assurance Resume
- Represent the quality unit during audits and inspections and support internal/external audits and inspections as part of the audit/inspection management team as needed
- Testing experience with applications across programming languages such as: .NET, Java, and Python
- Experience working in biological drug substance manufacturing, aseptic operations, protein formulation, vial and syringe filling
- Experience participating in, managing, and responding to corporate audits/regulatory inspections
- Provide technical support in all validation disciplines to meet objectives of quality, output and improving new and existing equipment
- Quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry
- Experience in investigations, change controls, and CAPAs processes System knowledge and training in Trackwise
- Experience of trending analysis
2
Responsibilities For Associate Specialist, Quality Assurance Resume
- Previous testing experience with solutions such as: Automation Anywhere (AA) , Blue Prism (BP), UiPath, Workfusion, or Pega
- Pharmaceitucal packaging experience
- Perform review, approval of QC qualification / validation / method transfer documentation
- Experience in audit settings
- Demonstrated statistical knowledge, ability to trend data and apply corrective actions to interpretations of complex data sets
3
Responsibilities For Specialist Quality Assurance Call Centerus Resume
- Heavy knowledge and experience in SAP or other management programs such as ERP or Oracle required
- Experience in investigation and change control process
- Previous experience in Quality Systems (e.g. Investigations, CAPAs, Change Controls)
- French - Advanced - Excellent Knowledge
- English - Intermediate - Good Knowledge
- Understanding of biopharmaceutical bulk, drug product manufacturing and fill and finish (aseptic) processes
4
Responsibilities For Associate Specialist Quality Assurance Resume
- System knowledge and training in Trackwise, SAP, Manufacturing Execution System (MES: Werum PAS/X), and Maximo
- Attend and contribute to staff meetings and attend appropriate training sessions
- Lead safe working practices and safety initiatives within their functional area
- Document and escalate call monitoring issues to management as necessary
- Applies comprehensive cGMP knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
5
Responsibilities For Specialist, Quality Assurance Analyst Resume
- Knowledge of cGMP regulations, practices, and trends pertaining to Quality System / Processes
- Working in the pharmaceutical or biotechnology industry
- Provide the test manager with input to testing estimates and progress reports
- Manage and coordinate day to day SAP testing activities at the project team level. Coordinate SAP setup of test environments and test data management
- Manage and coordinate day to day SAP testing activities at the project team level. Coordinates setup of test environments and test data management
- Support training activities
6
Responsibilities For Senior Solution Specialist Quality Assurance Resume
- Perform return sample coordination and ensure all mandatory assessments are complete
- Review and Approval of Investigations, CAPAs, and Change Controls
- Audit and Inspection Support for quality processes
- Review and approval of documentation
- Own and drive to closure Investigations, CAPAs, and Change Controls
- Drive Operational Improvement projects
7
Responsibilities For Associate Specialist Quality Assurance Systems Resume
- Actively Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control, Internal audit, Method Transfer and Investigations)
- Ownership of assigned Investigations, CAPAs, and/or Change Controls
- Provide updates to Site Sr. Leadership
- Own and/or Drive Improvement projects/initiatives
- Provide continuous call evaluation feedback to retirement consultants/retirement advisors through written evaluations and review with their managers
- Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
- Ensures that facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations
- Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations
8
Responsibilities For VP-specialist, Quality Assurance / QA Testing Resume
- Ensures that deviations from established procedures are immediately triaged, investigated and documented per procedures
- Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
- Experience with (or strong knowledge of) the following areas: QC Microbiology methods, Environmental Monitoring, Endotoxin testing, Growth Promotion testing, Water sampling, Bioburden testing and Result Reporting
- Direct bulk drug substance and drug product experience
- Previous QA oversight activities
- Solve complex problems and make scientific risk based decisions
- QA Disposition Responsibilities
- Generation of Trends Reports
9
Responsibilities For PFS Specialist Quality Assurance PBO Patient Accounting Resume
- Support program alignment and integration into the Amgen Quality Systems
- Follow assignments through to completion and meet timelines
- Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment
- Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate
- Experience with cGMP Production environments and an understanding of its regulatory requirements
10
Responsibilities For Solution Specialist Quality Assurance Resume
- Experience with TrackWise for supporting Nonconformance investigations, CAPA, Change Control and Complaints
- Display leadership attributes and drive improvement initiatives
- Demonstrated ability with project management (principles and techniques), initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development
- Analysis of complex problems and delivery of clear and timely feedback
- Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
- Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing
- B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
- Validation experience (e.g. cleaning, sterilization and computer related systems) and/or compliance areas
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