Associate, Quality Assurance Resume Samples
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Associate, Quality Assurance Resume Samples
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MW
M Ward
Milford
Ward
8926 McGlynn Way
Detroit
MI
+1 (555) 835 2548
8926 McGlynn Way
Detroit
MI
Phone
p
+1 (555) 835 2548
Experience
Experience
Detroit, MI
Associate, Quality Assurance
Detroit, MI
Bergnaum, Keebler and Schmidt
Detroit, MI
Associate, Quality Assurance
- Recommend design improvements or corrections to engineers throughout the development process
- Work alongside more senior members of the Quality Engineering Team to revise/develop and implement complex Quality systems that can be global in scope
- May represent QA on projects, work groups or process improvement teams
- Assists in the execution of efficiency improvement projects with guidance
- Create, manage, and/or implement change controls for various activities
- Performs related duties as assigned
- Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
Boston, MA
Associate Quality Assurance Engineer
Boston, MA
Rice, Schulist and Rempel
Boston, MA
Associate Quality Assurance Engineer
- Should be flexible to learn new technology & work in an Agile environment performing both Functional and Automation Testing roles
- Proactively communicate with Project Manager, developers and business analysts to resolve issues or questions pertaining to test creation or execution
- Develop defect coding in alignment with Risk Management files across a large portfolio of products for the Anesthesia, Respiratory, and Surgical BUs
- Working closely with distributed development resources in several countries
- Daily coordination of testing activities with the QA Manager and Project Managers
- Execute test plans during formal test periods for every Workday update
- Build regression and acceptance test scenarios working closely with Product Managers
present
Detroit, MI
Senior Associate, Quality Assurance
Detroit, MI
McLaughlin, Parker and Gorczany
present
Detroit, MI
Senior Associate, Quality Assurance
present
- Leading projects to develop improvements for the quality systems within Biogen
- Develop and maintain/manage client relationships
- Develop test governance processes and manage testing
- Manage engagements according to KPMG’s financial/cost management policies
- Work with Quality improvements and other quality challenges in close collaboration with internal and external customers
- Develop ETL test governance processes and manage testing
- Guide client development and realization of testing strategy and test cycle planning
Education
Education
Bachelor’s Degree in Computer Science
Bachelor’s Degree in Computer Science
New York University
Bachelor’s Degree in Computer Science
Skills
Skills
- Ability to share a responsibility with colleagues, due to work organized in teams
- Actively interact with other functions to solve challenges
- Ability to work in a dynamic environment with changing priorities
- Open to new challenges and possess a good sense of humor
- Is capable and competent in all relevant Manufacturing or Packaging processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.)
- Able to communicate effectively with other departments, management and operational personnel
- Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
- Proof-reading skills; ability to identify errors
15 Associate, Quality Assurance resume templates
Read our complete resume writing guides
1
Associate Quality Assurance Software Developer Resume Examples & Samples
- 3+ years video game and/or software development experience
- 3+ years developing automated / back-end solutions
- 3+ years experience with C#
- Working knowledge on front-end technology (ASP.Net MVC, Entity Framework, HTML5/CSS3, desktop application)
- Ability to design and write efficient and robust distributed back-end applications used on an automated system
2
Associate Quality Assurance Resume Examples & Samples
- Basic programming concepts
- Agility in adopting to changes
- Technical Skills: Java, Web (HTML, XML, CSS, PHP, Javascript), Software Developer in Test
3
Associate Quality Assurance Resume Examples & Samples
- Quick learner and agility in adopting to change
- Web (HTML, XML, CSS, PHP, Javascript)
- Scripting (Shell, Bash, Perl)
- Software Developer in Test
4
Senior Associate, Quality Assurance Resume Examples & Samples
- Support business development activities at clients, such as identification, proposal development, and other pursuit activities, while working with the appropriate KPMG resources from other service lines and industries
- Manage engagements according to KPMG’s financial/cost management policies
- Seven years of experience in software development, testing, project management, and business analysis
- Experience supporting large testing organizations, selling, delivering, building teams, and managing a practice
- Experience applying process improvement techniques
5
Associate, Quality Assurance Resume Examples & Samples
- Support the delivery of advisory services to clients related to business integration and testing
- Support business development activities at clients, including identification, proposal development, and other pursuit activities, while working with the appropriate KPMG resources from other service lines and industries
- Two years of experience in software development, testing, project management, and business analysis
- Bachelor’s degree from an accredited college/university in technical sciences or information systems
- Experience supporting large testing organizations, selling, delivering, and building teams
6
Senior Associate, Quality Assurance Resume Examples & Samples
- Support the delivery of advisory services to clients related to business integration and ETL testing
- Guide client development and realization of ETL testing strategy and test cycle planning
- Develop ETL test governance processes and manage testing
- Knowledge of software quality principles: risk based testing, requirements testing, writing SQL scripts and management
- Project management experience; ability to manage large ETL projects with understand of associated tools
7
Associate Quality Assurance Engineer Resume Examples & Samples
- Mentoring and training other QA Engineers
- Working closely with distributed development resources in several countries
- Strong understanding of software engineering and SQA methodologies
- Strong documentation and communication skills within a team environment
- Experience with MySQL and relational databases
- Forum administrator or moderator experience is a plus
- Experience with compatibility, security, recovery, code coverage, load, performance, or stress testing is a plus
- Experience with SQA automation and load testing tools (e.g. Selenium, Mercury LoadRunner, Mercury QTP, Watir, WebTest, Silk Test, TestComplete) is a plus
8
Associate Quality Assurance Engineer Resume Examples & Samples
- Validate a product against its requirements/acceptance criteria
- Write procedural test cases
- Analyze and understand product integration points and dependencies
- Communicate issues with product team and provide status to lead/management
- Dedicate time to learn new skills and testing tools
- Learning additional Quality Engineering disciplines (Performance, Security, Capacity, Accessibility, etc)
- Understanding, contributing to, and improving testing principles and processes
- Understanding the MEAN technology stack (MongoDB, Express, Angular, Node.js)
- This position requires a bachelors’ degree in Computer Science or related field, 1 to 3 years’ experience preferred
9
Associate Quality Assurance Specialist Resume Examples & Samples
- Evaluates current laboratory practices. Recommends changes or modifications to laboratory procedures in order to facilitate compliance with GLP standards
- Familiarity with Good Laboratory Practice standards and experience working in a GLP regulated research environment
- Must work well with numbers
10
Associate Quality Assurance Specialist Resume Examples & Samples
- Compiles and reviews manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner. Assures that any observations/deviations are properly investigated and explained
- Compiles and reviews raw data and batch records in accordance with cGMP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
- Reviews and approves document change requests
- Performs QA inspections including, but not limited to: filled vials, packaging, changeover and line clearances
- 1+ experience required
- Knowledge of cGMP requirements, PTC guidelines and ISO17025 is highly desirable
- Ability to understand and follow verbal or demonstrated instructions
11
Senior Associate, Quality Assurance Resume Examples & Samples
- Responsible for ensuring quality of product imported into the country, providing quality oversight and support to GDP related affiliate activities
- Responsible for the implementation and maintenance of Quality Management System required as per local regulations and Biogen standards
- Recognition, documentation and reporting of technical product complaints
- Develops Local Quality Management Systems consistent with in-country requirements and Biogen QMS
- Leads and coordinates Quality Management Reviews for Spain
- Leads local implementation and alignment of Global Quality Management Systems (Global Directives)
- Oversees affiliate training program (except BIU) and performs as Training Coordinator
- Oversees the documentation management system for local procedures (GxP and non-GxP) performing the role of Quality Unit to the GxP related documents not owned by the Quality Assurance function
- Supports TrackWise related tasks (Deviations, Change Control, Audit Modules, Technical Product Complaints, etc.)
- Responsible for oversight of activities relating to Good Distribution Practices
- Keeps up to date on cGDP and regulatory requirements and ensures that Biogen products are distributed in accordance with their licenses and with applicable regulatory requirements
- Develops and maintains local quality agreement with 3PL
- Ensures that suppliers and customers are approved in coordination with responsible departments. And approves any subcontracted activities which may impact on GDP
- Is authorized to manage returns, rejected and potentially falsified medicinal products
- Oversees distribution related issues
- GxP-related Audits and Inspections
- Supports local health authority Inspections with readiness, preparation & coordination. The host will be performed by QPPV and/or the person whose name is listed on the license
- Hosts Affiliate Audits and coordinates, performs related follow up and CAPA implementation
- Leads and coordinates self-inspection program
- Provides oversight of vendor management (affiliate external partners who perform GxP activities) including quality agreements
- Product related issues
- Acts as the local coordinator of Product Recall and manages locally mock recall exercises. Participates in Distributed Material Review Boards related product distributed in the Spanish market
- Supports Technical Product Complaint related investigations and follow up as necessary
- Ensures that suspected counterfeit product is immediately notified for investigation and coordinates local management as per Biogen procedures
- Cooperates with all necessary departments to ensure that communication to the authorities is appropriate, coordinated and approved
- Supports temperature Excursion Assessments
- Support to regulatory function
- Supports the development and implementation of regulatory SOPs in the affiliate
- Manages labelling issues, reviews and approves packaging materials in compliance with product’s license, internal procedures and applicable regulation
- Coordinates with the Pharmacovigilance function for the Safety and Benefit Risk Management activities such as Educational tools and DHPCs
- Please note this is a two year temporary contract*
- LI-EU4
- A minimum of 2 years in a similar function in the pharmaceutical industry, including experience in the Spanish specific quality environment
- Preferably experience as a delegated QP or QP from biotech or pharmaceutical industry
- Knowledge of and experience with the Good Distribution Practice
- Experience with development and maintenance of quality management systems
12
Senior Associate, Quality Assurance Resume Examples & Samples
- Designs and Manages the Solothurn Release and Compliance Team of subject matter experts who themselves are responsible for specific functions according to job descriptions
- Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn
- Design, review and maintain quality plan for the Solothurn site to ensure site GMP readiness as per project timeline
- Represent Solothurn Quality within the global quality organization to ensure local implementation of the global QMS
- Once operational, serve as the Quality lead and Responsible Person for batch release & compliance
- Ensure site training plan and system for content/documentation are in place and maintained
- LI-POT4
- Prior experience with fully electronic operations and management is preferred
- This position will require frequent international travel during the first two years of employment (up to 30% at times), periodically thereafter
- Dual Language preferred with a preferences for German and English
- Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems
- Demonstrated ability to work autonomously and to lead project teams in a matrix organization
- Candidates with experience in drug substance (or API) and drug product are preferred
13
Associate, Quality Assurance Resume Examples & Samples
- Listens carefully to others and responds appropriately
- GMP experience is required
- Experience with Microsoft Office is required
14
Associate Quality Assurance Resume Examples & Samples
- Communicates clearly with internal and external clients, both verbal and written
- Demonstrates flexibility in organizing work and priorities
- Adequate Problem Solving Skills and Decision making skills to identify and solve work related issues
- High School Diploma and 3+ years of related Scientific or Quality Assurance Experience, OR B.S. or B.A. with a scientific focus and 1+ year in Scientific or Quality Assurance Experience, required
- Knowledge of 21CFR is required
- Experience with inventory systems is required
15
Master Associate, Quality Assurance Resume Examples & Samples
- Responsible for executing QA operations required to assess, evaluate, and review operations on the floor (as defined above) against cGMPs and to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business
- Performs independent technical review of documentation during and post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings internally and to appropriate departments
- Capability to establish good relationships with others who have different values, cultural styles and perspectives
- Setting high and ambitious goals and standards for oneself and others, continuously raises the bar
16
Associate, Quality Assurance Resume Examples & Samples
- Review of validation documentation including protocols, test documentation and reports
- Reviewing GMP documents and raw data for compliance to applicable regulatory and corporate guidance documents, such as CAPA´s, deviations, operational procedures, change control documents
- Provide quality overview of activities associated with change control implementation and any documentation where QA needs to approve before implementation and upon completion
- Proactive identification and resolution of both technical and compliance issues/gaps
- Ensure a state of control for facility and equipment during shutdown and/or construction and subsequent release for use
- Modify quality systems within existing QMS framework and participate in quality system activities on corporate level
- Ownership of product changeover between campaigns
- Identify and implement improvement of work processes
- Solid GMP knowledge and practical/technical understanding of biotech/pharma production processes and unit operations within biotech or pharmaceutical production
- Knowledge of regulatory requirements
- Solid experience within at least one of the following areas: engineering, automation, validation, maintenance and I&C (calibration) or manufacturing
- Ability to share a responsibility with colleagues, due to work organized in teams
- Actively interact with other functions to solve challenges
- Ability to work in a dynamic environment with changing priorities
- Open to new challenges and possess a good sense of humor
17
Senior Associate, Quality Assurance Resume Examples & Samples
- Ensure each batch has been manufactured and tested in accordance with GMP regulations, the product specification file and the information submitted to the competent authority in the Clinical Trial Application. Furthermore keeps up to date on cGMP/cGDP and regulatory requirements and ensures that Biogen products are manufactured in accordance with their licenses, cGMP/cGDP and with all regulatory requirements in all markets served including Danish legislation
- Ensure that investigational medicinal products (IMP) and comparators being imported from outside the EU have been manufactured to GMP at least equivalent to 2003/94/EC
- Responsible for the preparation, review and assessment of batch documentation of IMP, as well as performing other duties as required to support departmental, functional and company goals
- Responsible for the development and maintenance of Quality Systems as applicable to the manufacturing of IMP
18
Senior Associate, Quality Assurance Resume Examples & Samples
- Reviews and approves and process incoming cases, ensuring global consistency and compliance. Perform the reviewer function to ensure the investigation was completed, aligned with the procedures, and regulatory requirements
- Supervises case investigation, monitoring correct CAPA follow up for established root cause
- Establish internal and external sample investigation capability that meets the need of future products
- Manage or support team for the investigation of high criticality cases aligning with relevant groups to identify root case and corrective action
- Performs metric reporting including those related to assigned CMOs, partners, supplier review meetings and audits. Communicate data trending, critical cases to impacted groups and management
- Identify meaningful KPI for stakeholders/ process and maintain a system to capture and monitor them
- Develop and maintain a global process for detection and testing of falsified medicines
- Familiar with the regulatory inspection process and ability to explain departmental processes and answer regulatory inquiries in a timely and accurate manner
- Manage overall efforts to simplify the processed to reduce errors and non -added value activities. Initiates continuous improvement initiative at a local or global level, to address issues and resolutions with managerial support. Provides leadership to team members on continuous improvement initiatives
- SME on regulatory and quality requirements. Ensure SOPs alignment with regulations and global procedures, directives and SOP of other departments. Manage discussions with other departments to ensure alignment
- Manages internal and external training program as well as training content creation and delivery, with particular attention to market-specific needs with respect to contractors, Affiliates or Distributors
- A minimum of 5 years of experience in Quality Assurance area, preferably in technical product complaints area
- Excellent Communication skills. Ability to communicate at all level in the organization
- Exceptional team player (ability to direct and participate in cross functional and management teams). Ability to develop strong network across company
- Fluent English is a must, any other European language would be an advantage
- Bachelor or Master’s Degree in life sciences or related faculties preferred
19
Associate, Quality Assurance Resume Examples & Samples
- Stops the manufacture, testing and/or distribution of biomedical products or services if the process or product is compromised
- Assists and/or leads operating entities in preparing for, hosting and closing out internal and external inspections/audits as necessary
- Participates in Operations and/or Quality Assurance meetings for review of quality concerns
- Identifies and participates in process improvement and standardization activities and monitors change for effectiveness
- May represent QA on projects, work groups or process improvement teams
20
Senior Associate, Quality Assurance Resume Examples & Samples
- Ensuring adherence to all regulatory licenses and regulations, review/approval of exceptions (Actions, deviations, remedial actions, CAPAs, change controls assuring accuracy and compliance to GMP requirements
- Support the development and performance of GxP Quality systems-related training, participate in internal/external compliance audits. Interface with key Quality, Quality Control, Manufacturing, CMO and PO&T customers
- Leading projects to develop improvements for the quality systems within Biogen
- Participation and leadership of risk management assessments in alignment with Biogen’s risk based quality approach is required
21
Associate Quality Assurance Analyst Resume Examples & Samples
- 1+ years with SQL
- 1+ years Financial/Brokerage Services experience
- 1+ years in any of the following: software QA testing, programming, or system support
- Understand SDLC
- MS Office
- Technical/Trade School or higher, or qualifying job experience
- MS SQL experience is desired.HP Quality Center
- Broadridge experience in the operations area of a brokerage, bank firm, or trust company
- ISTQB Foundation Level Certification (Preferred)
22
Associate, Quality Assurance Resume Examples & Samples
- Analyze business requirements to develop and execute comprehensive test plan with systematic QA methodology
- Participate in continuous improvement of testing process and procedures by analyzing reported bugs and then assessing test coverage and project execution around these areas
- Evaluate quality risk for product changes and propose test strategy to address risks
- Lead and train others in creating and executing test plans
- Bachelor’s Degree in Computer Science or similarly technical/quantitative field or: equivalent
- 0-2 years of professional experience or equivalent internship experience
- Passion for exploring new technologies and processes
23
Associate Quality Assurance Engineer Resume Examples & Samples
- Design, develop, document, and maintain automated tests suites for web and mobile applications
- Adherence to software/automation engineering best practices and standards using JavaScript, VBScript, SQL, and XML
- Collaborate with other technical resources to
- Java Script
- Understanding of and/or experience with
- Build Smart Automation frameworks – Drive simplicity
- Improve Engineering productivity (Both for SWE & TE)
- Continuous Improvement
- Highly technical and experienced with the following technologies (or similar)
- O Primary
- Minimun 2-3 years of dev/automation experience
- Hands-on software development / automation experience which includes any of the following
- 2+ years of automation scripting experience (not record and playback)
24
Associate Quality Assurance Analyst Resume Examples & Samples
- The Associate QA will be trained and mentored to develop skills in the following areas
- Effective planning and organization skills
- Copes well under pressure & with uncertainty
- Flexible & adaptable in the face of changing priorities or circumstances
- Drives for results
- Rapid learner
- 0-1 years’ experience in an office environment
25
Associate, Quality Assurance Resume Examples & Samples
- Assesses and approves document change controls, manages document lifecycle activities. Executes activities associated with document lifecycle management which include but are not limited to; document creation and change control guidance/review/approval, document issuance oversight, document archival and maintenance
- Contributes to moderately complex tasks/investigations. Executes activities including; some moderate technical writing, moderate investigation support (root cause analysis/impact assessment), project representation (routine or moderate complexity) or management (routine or minimal complexity)
- Supports resolution of both technical and compliance issues/gaps of minimal to moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, technical problem solving (tools or enterprise systems) within function and across multiple functional areas
- Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions. Provides some advanced engagement and contributions in meetings
- Basic understanding of cGMP regulations in pharmaceutical or biotech manufacturing environment is recommended
- Prior training or experience with document management and/or regulatory audits preferred
- A minimum of 1 - 3 years’ experience within Quality Assurance or related function preferred
26
Associate Quality Assurance Specialist Resume Examples & Samples
- AA Airport Gate Agent experience a big plus
- AA RES experience a plus
- Detail oriented and excellent organizational skills
- Requires an associate’s degree or equivalent technician experience
- Must be able to read, write, fluently speak and understand the English language
- Must have 3-4 years of experience in performing quality assurance in Sabre PSS
- Ability to handle multiple projects simultaneously and to effectively manage change and customer expectations
27
Associate, Quality Assurance Resume Examples & Samples
- Rigour in monitoring records and in respect of procedures and regulations
- Knowledge in regulatory requirements and quality of an “exploitant” facility
- Skills in pedagogy, pragmatism and diplomacy,
- Ability to listen and communicate, and adapt communication to the different stakeholders
- Able to identify and manage priorities
- Search and use sources of information, use IT technology communication
28
Associate, Quality Assurance Resume Examples & Samples
- Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) related to technical areas (Manufacturing, QC Testing, Engineering, Maintenance, Metrology or Automation - Delta V, Syncade, etc.)
- Provide support to areas within the facility and may participate on projects across sites; requiring a good working knowledge of regulatory and Biogen Quality and Process systems as well as working knowledge of technical areas (Manufacturing, QC Testing, Engineering, Maintenance, Metrology or Automation - Delta V, Syncade, etc.)
- Work alongside more senior members of the Quality Engineering Team to revise/develop and implement complex Quality systems that can be global in scope
- Maintain knowledge of relevant FDA/EMA regulations and compliance
- Approximately 4 years of experience in pharmaceutical or biotech manufacturing environment
- Previous experience within Quality Assurance or related function is preferred
- Good communication skills in English, verbally and written. Dual language is preferred with a preference for German and English
- Technically orinented role including experience of the validation of laboratory, production equipment automation systems and knowledge of production methodology involved in biopharmaceutical production
- Self driven, demonstrated ownership and responsibility for work assignments
- Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work with colleagues across the organization
29
Senior Associate, Quality Assurance Resume Examples & Samples
- Author, review and approve complex GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) requiring the ability to grasp and apply regulatory and compliance knowledge from multiple markets/agencies with limited support
- Interact with Regulatory agencies directly during audits as well as providing input into such documents as regulatory filings
- Proactively identifies and resolves technical and compliance issues/gaps
- Provide support to multiple areas within and between facilities; requiring a high level of regulatory and Biogen Quality and Process system knowledge
- Identify gaps, revise/develop and implement Quality systems that can be global in scope with limited supervision
- Ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)
- Act as primary Quality Engineering interface for change control activities - may involve authoring/reviewing/approving change controls
- 8 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with regulatory audits and at least 3 years of experience within Quality Assurance or related function is preferred
- Prior experience with regulatory audits
30
Senior Associate, Quality Assurance Resume Examples & Samples
- Author, review and approve moderately complex GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) requiring the ability to grasp and apply regulatory and compliance knowledge from multiple markets/agencies with limited support
- Approximately 6 plus years of experience in pharmaceutical or biotech manufacturing environment
- At least 3 years of experience within Quality Assurance or related function is preferred
- Technically oriented role including experience of the validation of laboratory, production equipment, automation systems and knowledge of production methodology involved in biopharmaceutical production
- Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work and influence without authority across the organization with limited supervision
31
Associate, Quality Assurance Support Resume Examples & Samples
- Performs and delivers on routine assignments/projects for assigned area(s) of responsibility
- Creates and maintains appropriate documentation and procedures, as needed
- Maintains a high level of accuracy in content, spelling, grammar, and punctuation
- Provides analysis and metrics for assigned area(s)
- Schedule and facilitate both on-site and cross-location calibration sessions and process meetings
- Ability to write routine reports and business correspondence, training documentation and process procedure documentation
- Respond to questions related to quality and amicably resolve disputes related to audit findings
- 1-3+ years of experience with Quality Assurance, Documentation or Customer Service experience in a Financial Services company
- Intermediate mathematical skills such as addition, subtraction, multiplication, and percentages
- A demonstrated track record of consistently meeting and/or exceeding performance expectations
- Possesses a bias for action and avoids workplace distractions
32
Senior Associate, Quality Assurance Resume Examples & Samples
- Oversee from QA perspective all Commercial Logistics department activities and procedures
- Support decisions relating to product distribution
- Training of logistics team on GDP matters
- Quality review of distribution related procedures
- Development of QA owned distribution related procedures
- Support Biogen QA supervision of the Central Distribution Warehouses
- Participate in Audits and Quality Management Reviews
- Update Quality Agreement and monitor partner’s performance against it
- Maintain frequent contacts with partner’s QA organization to ensure alignment
- Oversee partners’ deviation and CAPA management
- Support and manage Change Controls
- QA Management of Biogen’s Exceptions, CAPAs, Change Controls relating to distribution of products
- QA review of distribution related issues and temperature excursion assessments
- QA review of deviations and CAPAs
- QA responsible for Change Controls
- Oracle QA status changes for on hand product
- QA Management of logistics processes related to recall
- Support development of retrieval plan including distribution partner’s communication
- Oversee returns process, shipments documentation, returned units inspection and reconciliation
- Manage Oracle QA status changes
- Coordinate and supervise logistics partners and Logistics department activities and associated
- Minimum of 5 years of experience in pharmaceutical or biotechnology industries in GDP or GMP environment; QA or Regulatory experience preferred
- Knowledge of deviation, CAPA and change control, QA management
- Excellent communication skills, able to communicate at all levels of the organization
- Assertive and diplomatic, able to influence without direct reporting line
- Bachelor’s degree in Supply Chain, Pharmacy or other
33
Associate, Quality Assurance Resume Examples & Samples
- High school diploma or equivalent with 4-7 years’ relevant experience OR
- AA/AS degree with 3-6 years’ relevant experience OR
- BA/BS degree with 2 -5 years’ relevant experience
- Related discipline and certification in assigned area a plus
- Experience in a lead role a plus
- Experience with statistical sampling methods a plus
- Ability to communicate and work with teams
- Ability to read and interpret SOPs and function within the scope of procedures
- Is capable and competent in all relevant Manufacturing or Packaging processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.)
- Strong proficiency with basic math skills and basic experience with computers and software applications required
- Able to communicate effectively with other departments, management and operational personnel
- Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
- Proof-reading skills; ability to identify errors
- Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
- Lift 15 lbs
- Wear appropriate gowning as required
- Ability to read for extended periods of time
34
Senior Associate, Quality Assurance Resume Examples & Samples
- Responsible for executing the tactical operations required to assess, evaluate, and review on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance for assigned area to ensure compliance with all applicable regulations and SOPs and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business
- Identifies and reports deviations, as appropriate. Supports execution of remediation/CAPA activities required to continue operations or move a process to the next milestone. Supports investigation team to identify root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations
- May be required to escalate critical issues to the senior management team based on severity of the issue
- Responsible for coordinating tasks associated with quality oversight of the change management system for the assigned QA area. This includes verifying changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business
- Performs technical review of documentation during and post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved prior to submitting to the next step for Approval and Release and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures
- Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems. May attend project team meetings to support QA guidance and oversight to such improvements. May utilize Yellow-Belt skills to support process improvement initiatives via the BPE program
- May be asked to support internal or external inspections
35
Associate Quality Assurance Engineer Resume Examples & Samples
- Excellent logic skills and analytical abilities
- Passion for research, problem solving, and high quality deliverables
- Positive, collaborative team player with good verbal and written communication skills
- Participate in a complete development lifecycle from inception through release, working with an agile methodology
- Develop test plans for capabilities of Payroll, Absence, or Time Tracking products
- Build regression and acceptance test scenarios working closely with Product Managers
- Execute test plans during formal test periods for every Workday update
- Write automated test scripts using cutting edge tools
- Liaise with other teams to facilitate technical and performance testing related to functional areas
36
Marketing Associate, Quality Assurance Resume Examples & Samples
- Document key operational processes of the department, process inputs and outputs, dependencies, and risks
- Create internal SLAs associated with process inputs and outputs with performance metrics
- Perform periodic audits that key marketing processes are working as expected
- Perform quality control checks against marketing content that require quarterly data updates such as fund fact sheets, presentation decks, and digital properties
- Help maintain a process improvement log of risk-related and operational issues experienced by the department and report metrics from it on a periodic basis and identify trends in the information
- Lead the development of operational and technology solutions needed to address process gaps and recommended efficiency
- Manage and troubleshoot risk-related issues that arise
- Perform validation tasks and reviews as necessary against newly created marketing content
- Liaise with the Compliance and Legal Department concerning risk mitigation and regulatory matters
- An understanding of performance, investment analytics, portfolio characteristics, and data
- Prior experience with applying process improvement techniques and risk analysis
- A clear understanding of the operational aspects, including data needs, of the asset management business
- Excellent problem-solving skills and the ability to think analytically and strategically
- Self-starter with excellent communication skills, oral and written
- Prior work with regulators within the financial services industry (SEC, FINRA) is a plus
- Bachelor’s degree in business administration, finance, marketing, operations management, or like discipline
- 3+ years of professional experience, preferably within the asset management segment of financial services
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Associate Quality Assurance & E-file Analyst Resume Examples & Samples
- Provide quality assurance of assigned products including the systems that create, measure and maintain these products
- Evaluate design, specifications, and processes from the perspective of the customer through testing of products
- Assist in the creation of documentation and enforcement of product and performance standards
- Perform content-related and end-user testing of products
- Identify and investigate problems encountered through the testing process
- Strong analytical and diagnostic abilities
- 1-2 Years experience in accounting and 1065 & 1120 US taxation Knowledge required
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Associate Quality Assurance Engineer Resume Examples & Samples
- Create and maintain manual test cases and test plans
- Design, implement, and maintain automation tests
- Work with internal customers and product owners to identify user stories and features
- Help create quality assurance standards and adhere to existing standards
- Assist DevOps to automate the build process for web and mobile applications
- Be comfortable with Git source control with a focus on the Gitflow Workflow
- Ability to work independently, or in groups, while maintaining a courteous attitude when dealing with customers
- Ability and willingness to complete several concurrent tasks in a fast-paced, detail-oriented, and multi-tasking environment
- Ability to set objectives, manage project timelines and see projects to completion
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Associate Quality Assurance Engineer Resume Examples & Samples
- Excellent technical and communication skills
- Carry out Functional testing for Investment Management and/or similar application
- Functional Data testing on Oracle & Sybase database’s
- Test Data mining for the identified test cases as applicable
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Associate Quality Assurance Engineer Resume Examples & Samples
- Develop defect coding in alignment with Risk Management files across a large portfolio of products for the Anesthesia, Respiratory, and Surgical BUs
- Interface with various internal resources such as Risk Management, Quality Assurance, Clinical Medical Affairs, Manufacturing, IT (as it pertains to SAP), Regulatory Affairs, and Complaint Management
- Train/implement new coding across the BUs and monitor and sustain the process
- Communicate status and risks to Executive Management and BU Leadership teams where appropriate
- Assist with root cause investigations as appropriate (NC/CAPA/SCAR)
- Provide other department support as requested by immediate supervisor or Sr. Director, RAQA and Customer Advocacy
- Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards
- Bachelor Degree in Engineering (Industrial, Mechanical, Biomedical, etc.)
- 1-3 years Quality System experience within the Medical Device field
- Project Management experience preferred
- Risk Management experience preferred
- Familiarity of Surgical/Anesthesia/Respiratory products preferred
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Associate, Quality Assurance Resume Examples & Samples
- Material/Product Disposition: Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution. Supports Visual inspection AQL execution and oversight
- Controlled Document Assessment: Reviews documents for compliance and identifies gaps in existing quality systems. Initiates opportunities for process improvements
- Process Validation Oversight: Provides quality oversight with new product/project initiatives. Serves as a consultant for quality related issues and assuring compliance with regulatory requirements and site procedures
- QA Document Change Control and Production Record Issuance: Responsible for controlling master production records and issuing working copies of these records according to the production scheduled. Records are printed and verified to be accurate prior to issuance. Assures compliance against applicable PRCD’s providing QA controlled document creation, revision, retirement, and issuance requirements
- 4 years related pharmaceutical/biotech experience including Visual Inspection
- Ability to prioritize, plan and schedule
- Investigative decision making skills
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Senior Associate, Quality Assurance Resume Examples & Samples
- Relevant experience in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of quality assurance, regulatory affairs/sciences
- Excellent communication, presentation and exceptional written skills and fluency in German, English (written and spoken) and some understanding of French
- Good project management skills *LI-POT2
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Associate Quality Assurance Engineer Resume Examples & Samples
- Use existing tools and techniques to execute test
- Document, track and escalate issues as appropriate, using JIRA or similar tools/means
- Build Deployment on Test Environment
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Senior Associate, Quality Assurance Resume Examples & Samples
- QA support in Drug Substance technology transfer. Approval of process validation master plan, protocols and reports
- QA Approval of sample plans
- QA assessor and/or approver of change control requests
- Assess drug substance quality through review batch production records for intermediate products and drug substance, and through being on the floor during manufacturing as applicable
- Be part of the disposition process of Drug Substance batches, with possibilities to become delegated QP
- Support during internal audits, third party audits and regulatory inspections
- Work with Quality improvements and other quality challenges in close collaboration with internal and external customers
- Minimum 5 years’ experience from biotech or pharmaceutical industry
- Good communication skills and fluency in English (verbal and written)
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Operations Associate, Quality Assurance Resume Examples & Samples
- Reviews batch records, QC testing records, and all supporting records Issues manufacturing batch records and labels
- Maintains effectiveness of the Quality System
- Assures the Bulk Drug Substance and Final Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements
- Compiles complete batch records through collection of documentation from multiple sources (production, labs, etc.)
- 5+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities
- Prior cGMP documentation practice Technical Requirements
- Ability to manage investgations and change records preferably with Trackwise® quality management software
- Solid knowledge and application of cGMP, ICH, FDA, EMA regulations or guidelines
- Ability to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines
- Ability to review data to ensure data is well organized with complete documentation
- Ability to write SOPs, batch production records and reports independently
- Ability to operate within a clean room environment
- Ability to problem solve and execute/monitor corrective action independently
- Understanding and adherence to applicable regulatory authority and guidelines
- Data archiving and maintenance
- Write, edit and review Standard Operating Procedures (SOPs)
- Understanding and application of Risk Assessment tools (Hazard Analysis, Fault Tree Analysis, FMEA, etc.)
- Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations
- Ability to cross-train on techniques across multiple groups
- Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions
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Associate, Quality Assurance Resume Examples & Samples
- 3 years experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital
- 2 years experience in QA, QC or Quality Auditing
- Good analytical, problem solving skills and effective verbal and written skills
- Strong analytical and problem solving skills. Strong skills needed to advance compliance and quality in operations; must deal effectively with management and staff in areas, at BHQ, and outside the organization
- Persuasive skill to achieve compliance with relevant procedures
- Must display tact, diplomacy and professionalism in difficult situations
- Must protect the confidentiality of sensitive information in the department. Must operate as a team member
- May represent QA on projects, work groups or process improvement teams.Participates in and/or leads internal quality reviews of critical areas, operations, and processes
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Associate Quality Assurance Manager Resume Examples & Samples
- Strong analytical and problem solving capabilities are required
- 5+ years of experience with leading Manual and Automation QA teams
- Strong knowledge and extensive experience in various types of testing (Automation, Functional, Regression, Browser compatibility, Integration, System, Configuration, Smoke, Accessibility, etc.) is required
- Knowledge of QA automation frameworks and tools is required
- Must have experience with building and enhancing automation frameworks and automation test scripts based on business use cases
- Must be able to lead and work as part of a team with good work ethics
- Experience with working in an Agile environment is required
- Knowledge of Node.JS is required
- Knowledge of Mobile Test Automation (e.g. Appium) is an asset
- Sound Knowledge of webservice, RESTful service testing is required
- Must have sound knowledge and experience working with Continuous Integration and continuous delivery (CI, CD); various release deployment processes
- Experience with Java, scripting languages, Linux platform and Relational DBs
- Knowledge of ‘page performance’ is a plus
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Associate, Quality Assurance Resume Examples & Samples
- Three years’ experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital
- Two years’ experience in QA, QC or Quality Auditing
- Demonstrated effective verbal and written skills
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Associate Quality Assurance Analyst for UW Resume Examples & Samples
- ) Confidence, poise, and professionalism when interacting with customers and leaders in a global environment
- ) Strong communication, customer management, and meeting facilitation skills
- ) Ability to establish effective relationships with customers and operations team members
- ) Demonstrated the ability to multi-task and rapidly learn diverse tasks/ responsibilities
- ) Knowledge in project management is a plus
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Associate, Quality Assurance Resume Examples & Samples
- Minimum of 2 years (Associate II) or 5 years (Associate III) industry experience in Biologics Manufacturing and/or QA Operations
- General understanding of relevant FDA/EMA regulations
- Ability to develop innovative/creative solutions to issues of moderate complexity
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Associate, Quality Assurance Resume Examples & Samples
- Provides on the floor QA support during manufacturing operations
- Supports resolution of both technical and compliance issues/gaps of moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas
- Control and release of equipment from maintenance, validation, change control and product changeover
- Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions
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Senior Associate, Quality Assurance Resume Examples & Samples
- Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval
- Review/approval of change control documents and activities associated with change control implementation
- Facility and equipment controls and release during shutdown, construction, product changeover
- Provide cGMP guidance and quality support of Manufacturing on the floor issues, including assistance with deviation initiation
- Observe critical manufacturing process operations to ensure adherence to internal procedures and regulatory guidelines
- Review of PM workorders and CM work orders as applicable to cGMP systems
- Develops and implements aspects of various Quality Systems/System Improvements
- Performs QA review of alarm assessments for cGMP equipment
- Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively
- Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel
- Demonstrated troubleshooting and problem-solving skills
- 8+ years of Quality-related experience in the following disciplines
- GMP review of validation documentation and strong knowledge of equipment/facilities/utility systems
- Robust knowledge of current global Regulatory Quality requirements
- Agency inspection experience
- Previous experience with Quality Systems development
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Associate, Quality Assurance Resume Examples & Samples
- Provides on the floor QA support for Manufacturing Operations
- Executes activities including: deviation and Global Change Control support
- Supports resolution of both technical and compliance issues/gaps of moderate complexity
- Minimum of 2 years (Associate II) or 5 years (Associate III) years industry experience in either Manufacturing or QA
- General understanding of Quality role and concepts
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Associate, Quality Assurance & Documentation Resume Examples & Samples
- Partners with more senior team members to ensure assigned training materials, procedures, plans and/or programs reflect business needs and organization readiness
- Represents the interests of assigned area/team on basic projects assigned by management I including technical, procedural and IT related
- Responsible for quality monitoring which may include calls or processes performed by Customer Solutions, including Vendors
- Perform quality audits for other business units as required
- Conduct quality monitoring and deliver timely feedback to trainees
- Responsible for reading and interpreting documents to review work for quality. i.e. policies and procedures
- Communicate quality updates to the operational areas as required
- Partner with operations teams to stay up to date on processes and procedures
- Demonstrate dependability, flexibility and sound judgment by adhering to schedules and meeting all productivity, quality and performance standards as well as taking ownership for your actions
- Ensure proper guidelines are followed in accordance with company company policies, procedures
- Intermediate proficiency or educational experience in: Microsoft Office (Outlook, Word, PowerPoint, Excel) and also have exceptional keyboarding skills
- Demonstrate strong execution, problem solving and analytical skills
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Associate Quality Assurance Engineer Resume Examples & Samples
- Design and Execute test cases in a timely manner so as to meet project timelines
- Proactively communicate with Project Manager, developers and business analysts to resolve issues or questions pertaining to test creation or execution
- Provides data around perceived risks and mitigation strategy
- Manage and maintains Continuous Integration/Continuous Development (CI/CD) pipelines
- Good understanding of the Quality Assurance concepts
- Automation expertise using tools like QTP/UFT/Selenium/Fitnesse/Cucumber etc
- Knwoledge of SOAP UI, Unix Commands and SQL will be a plus
- Acceptance test-driven development a plus
- 1 – 2. 5 years of relevant IT experience
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Associate, Quality Assurance Analyst Resume Examples & Samples
- Work with the development and business analysis teams to develop acceptance test plans for new products and new functionality on existing products
- Execute test plans and report defects to development team. Verify fixes from development
- Should be able to estimate the testing efforts for automation, from high level requirement
- Keep your manager up to date on test planning and execution status, defects and blocking issues
- Help setup and manage multiple test environments
- With the rest of the test team, peer review test approach and test cases for a given release
- Identify test cases suitable for automation and performance testing
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Associate, Quality Assurance Analyst Resume Examples & Samples
- Maintain standard test templates for functional test plans, test scenarios and test cases
- Design and write test cases
- Execute/run test cases, review test results and report defects
- Design automation test cases on the existing framework and can also come up with new framework
- Is able to work as a dynamic / hybrid Tester for Functional and Technical Testing
- Communicate with all levels of management on test status. Meet daily with testers in London and New York on testing deliverables
- University Graduate with a Computer Science or an Engineering degree
- Strong Background in Testing Methodology
- 2-4 Years in a structured testing organization
- 1-2 Years in Automation Testing or Development experience using Python or Java is a must
- Good DB Testing experience
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Senior Associate, Quality Assurance Resume Examples & Samples
- Training: supporting annual training plan review
- Define requirements and ensure maintenance Affiliate’s Quality Management System and review department owned procedures
- Processing of distribution related incidents
- Support inspection and audit readiness and follow-up
- Back-up the Responsible Person acc. to article 52 a German Drug Law
- About 2 years’ experience in the pharmaceutical industry
- Attentiveness of details
- Language: Fluency in German and English
- Experienced in Microsoft Office programs
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Senior Associate, Quality Assurance Resume Examples & Samples
- Drive timeline activities to support the readiness of the quality systems under his responsibilities and supporting business processes for the start-up of GMP production in Luterbach
- Design, review and maintain related topic of quality plan for the Luterbach site to ensure site GMP readiness as per project timeline
- Represent Luterbach Quality within the global quality organization to ensure local implementation of the global QMS under his responsibilities
- Responsible for managing the Quality training and system for documentation are in place and maintained
- Act as support for the implementation of operational Quality systems
- Approximately 7 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred
- This position will require frequent international travel during the first two years of employment (up to 20% at times), periodically thereafter
- Must have proficiency with the Quality systems and business processes associated with automation and integration of testing and production systems
- Strong presentation and organizational skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
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Senior Associate Quality Assurance Resume Examples & Samples
- Perform review of product receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
- Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and Validations. May also support execution of these tasks
- Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight
- Represent the Quality Unit during audits and inspections as needed
- Support internal/external audits and inspections as part of the audit/inspection team as needed
- Perform additional duties as specified by management
- Bachelor’s degree and 2 years of Quality experience OR
- Associate’s degree and 6 years of Quality experience OR
- High school diploma / GED and 8 years of Quality experience
- Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
- Good written and oral communication
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Associate, Quality Assurance Resume Examples & Samples
- Creation and revision of specifications for current materials/products and new materials/products supporting tech transfer activities and artwork revisions
- Create, manage, and/or implement change controls for various activities
- Creation or review of quality metrics for monthly Quality Review Board meetings. Ensure metrics are met for items personally responsible for
- Knowledge of deviation and CAPA system – able to perform investigation and root cause analysis
- Participate in internal audits and regulatory inspections as required
- Creation and revision of SOPs utilizing an electronic system
- Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site. Knowledge of LIMS and Oracle systems
- Batch Record Review for media fills, compounding/filling/capping, visual inspection, labeling and packaging activities
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Associate Quality Assurance Engineer Resume Examples & Samples
- Executes manual functional testing based on analysis and understanding of the requirements and deployment environment
- Verifies test results through analysis of graphical user interfaces, databases, printed output, and data transmissions
- Analyzes requirements (solution comments, design specifications, and other documentation) and creates test cases to exercise product functionality
- Documents and communicates issues found during the course of testing and works with Development to resolve the issue
- Provides management with requirements coverage analysis reports, test run results, and defect tracking reports
- May build and execute test scripts utilizing software testing automation tools
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Associate, Quality Assurance Resume Examples & Samples
- Performs batch record review, product release, and disposition
- Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed
- Assists in the execution of efficiency improvement projects with guidance
- Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPs
- Ensures gathering of data, investigations and deviations are timely and compliant
- Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing)
- Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
- Bachelor’s degree in a scientific discipline with 0-2 years Quality Assurance experience in a GMP manufacturing environment; or a high school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment
- Six Sigma or ASQ certification preferred
- Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to identify aberrant data and potential quality/compliance concerns escalating to management
- Has sufficient skills and knowledge in the use of computers and associated computer technology. Computer technology relates to both the hardware and software used in performing common computing tasks. (Word, Excel, Outlook, Power Point basics
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Senior Associate, Quality Assurance Resume Examples & Samples
- IPQA
- Sampling and Dispensing activities at Warehouse
- Dispatch & Release
- Minimum one year experience in relevant area
- English Writing & Reading skill
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Associate, Quality Assurance Resume Examples & Samples
- Perform timely release of products to meet business objectives
- Resolve all TPM investigations / deviations to ensure product supply
- Preparation, and review of Quality Agreements with GMP Vendors
- Conduct periodic and for cause audits of existing GMP vendors
- Review and approval labelling and component specifications
- Initiate TPM / Ferring Affiilates changes within the QA-Track System
- Other projects as assigned by Quality Assurance and GQA Management
- Prepare quality documents to support Annual Reports and other regulatory submissions
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Junior Associate, Quality Assurance Resume Examples & Samples
- Develop and implement testing and quality assurance artifacts for new and existing software
- Document results accurately and reports results tactfully and concisely
- Recommend improvements to existing software programs, especially for unit tests
- Exercise independent judgement within defined parameters to determine appropriate action
- Log and track system flaws using the JIRA issue tracking system
- Troubleshoot application issues and coordinate issue resolution with operations, functional, and technical teams
- Provide coaching to Junior Associates
- Works independently on simple to medium complex projects
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Trainee Associate, Quality Assurance Resume Examples & Samples
- Day-today-day technical, research, and analytical support
- Ensure that software functionality is implemented according to the product stakeholder needs
- Utilize standard procedures to solve routine, on-going problems
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Software Associate Quality Assurance Analyst Resume Examples & Samples
- Creates and runs simple test cases to identify defects in software. Documents potential issues and provides the reports to software teams
- Partners with software teams to ensure issues are resolved in a timely manner. Retests software following problem resolution to ensure issues are resolved and identify any new issues
- Supports software implementation and enhancement projects. Ensures that the final product is working properly
- Assists in the assessment and planning of software tests. Provides recommendations for new methods and criteria to be tested
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Senior Associate Quality Assurance Resume Examples & Samples
- Masters Degree OR
- Bachelor's Degree & 2 years of Quality experience OR
- Associate's degree & 6 years of Quality experience OR
- High school diploma/GED & 8 years of Quality experience
- 5+ years biotech, pharmaceutical industry
- Proficiency with electronic systems LIMS, TrackWise in supporting Nonconformance investigations, CAPA, Change Control, Complaints etc
- Demonstrated experience participating in, managing, and responding to QMS related tasks and responsibilities
- Good understanding of cGMP requirements for Product Disposition, Investigations, CAPA, and Change Control
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships
- Application of project management principles and techniques
- Good understanding of cGMP and other applicable regulatory requirements
- Demonstrates ability with project management, including initiating and leading teams
- Demonstrates ability to be flexible and adaptable to support business needs
- Excellent conceptual problem solving/strategy skills, pragmatically define scope, and manage execution
- Strong knowledge of the Biotech industry and QMS related processes involved in API, DS and DP manufacturing and distribution, QA, analytical laboratory, and validation
