Senior Quality Assurance Specialist Resume Samples
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Senior Quality Assurance Specialist Resume Samples
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GM
G McKenzie
Gloria
McKenzie
35730 Franecki Motorway
Houston
TX
+1 (555) 130 1995
35730 Franecki Motorway
Houston
TX
Phone
p
+1 (555) 130 1995
Experience
Experience
Detroit, MI
Senior Quality Assurance Specialist
Detroit, MI
Altenwerth, Smith and Zieme
Detroit, MI
Senior Quality Assurance Specialist
- Work directly with other key Company departments to ensure compliance and productive working relationships
- You’ll work hand in hand with our development team while being part of a Quality Assurance community
- Provide assistance/support with Sponsor visits
- Participate in the design, development and programming of the quality assurance reports based on access to the appeal case management system
- Develop and implement procedures and test plans for assuring quality in a system development environment which supports large databases and applications
- Utilize MAXIMUS ISO-related documentation standards and tools to assist project team members to actively engage in and develop draft quality documents
- Review Instrument qualifications to ensure that work is performed as per the procedure
Philadelphia, PA
Senior Quality Assurance Specialist
Philadelphia, PA
Hills, Doyle and Satterfield
Philadelphia, PA
Senior Quality Assurance Specialist
- Provide support for the product artwork process
- Work collaboratively with local CDO(s) and Distributor partners; Handle returns, rejects and destruction; and oversee product rework
- Provide input to the development of quality tools to be used in the quality review process
- Perform other duties as may be assigned by management
- Provide support for management of complaints, deviations, CAPA's and change controls associated with commercial products
- You’ll design, develops, executes, reports, and debugs functional, mobile, browser, accessibility and localization tests
- Evaluate and perform trend analysis and report results for quality metrics. Make recommendations and drive implementation based upon findings
present
New York, NY
CT Senior Quality Assurance Specialist
New York, NY
Hickle-Schultz
present
New York, NY
CT Senior Quality Assurance Specialist
present
- Manage onsite Clinical Trial client audits from start to finish
- In follow up to client audits, track and initiate effectiveness checks for ACM corrective and preventive actions
- Identify trends and areas for improvement and provide input to quality area and manager(s) to enhance training or create action plans to address issue(s)
- Works with the technical development team during the defect resolution process including working closely with the BA and PM during re-testing and validation
- Provide continuing support for development, implementation and maintenance of the Pharmaceutical Quality System and supplier management program
- Assist with development and monitoring of quality improvement initiatives and quality metrics within laboratories
- Positive attitude towards work, environment and co-workers
Education
Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
University of Arizona
Bachelor’s Degree in Chemistry
Skills
Skills
- Excellent working knowledge of Quality Systems and cGMP standards applicable to product life cycle from development to commercial
- Strong organizational ability and problem solving capability
- Strong interpersonal, communication and negotiation skills, including the ability to deal professionally with difficult individuals and problematic situations
- Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma,
- Knowledgeable of statistical techniques and application experience
- Knowledge of tools, concepts and methodologies of Quality Assurance
- Attention to detail with an ability to detect and correct errors / inconsistencies in various types of documents
- Ability to deal with problems arising, develop and maintain good relationships with third parties
- Strong analytical skills with excellent problem solving
- Knowledge of professional software engineering practices & best practices for the full software development life cycle
15 Senior Quality Assurance Specialist resume templates
Read our complete resume writing guides
1
Senior Quality Assurance Specialist Resume Examples & Samples
- Serve as a point of contact with Engineering, Facilities, and Capital Projects to identify project needs and ensure appropriate resources are available, as required
- Provide quality oversight of plant validation and engineering activities
- Collaborate with customer group (Validation, Engineering, Facilities, IT, QS) to ensure quality systems are monitored and established metrics are met
- Participate as QA representative on Shire Technology Transfer teams to support product tech transfers into Shire US manufacturing plants; ensure seamless handoff to Plant QA Management
- Provide support during regulatory agency site inspections
- Maintain an environment of teamwork and collaboration
2
Senior Quality Assurance Specialist Resume Examples & Samples
- 75%: Responsibilities include support of Commercial QC Raw Material Operations Program Support for the following
- Raw Material Method Suitability, Validation and Transfer
- Raw Material Lab procedure and technical report(s)/protocol(s) review and approval
- Review and approval of Raw Material Non-Conformance, Change Controls, Deviations and CAPA
- Material specification review and approval
- Compendia assessment review
- Disposition and release of Chemicals and Gases
- 25%: Provide support for supplier quality oversight
- Vendor Change Notification review and approval
- Supplier audits and assessments
- Supplier Quality Agreements
- A minimum of 8 years in a cGMP biotech and/or pharmaceutical environment
- Familiar with USP, EP, JP and Quality ICH guidelines related to QC systems
- Quality experience in drug substance manufacturing
3
Senior Quality Assurance Specialist Resume Examples & Samples
- QA contact for North Reading and Belmont warehouse operations
- Experience with Enterprise Resource Planning systems or SAP related inventory systems, as well as TrackWise and LIMS systems
- Previous experience with Supplier Oversight is a plus
- Living the values is a basic expectation for all Shire employees. Shire expects all employees to live the BRAVE values
4
Senior Quality Assurance Specialist Resume Examples & Samples
- Drug Product Exception Reporting OOS, Trending, Aberrant Results
- Stability
- Reference Standard & Critical Reagents
- Method Validation & qualification
- Method Transfer
- Annual Method evaluations
- Specification Setting
- Laboratory Operations
- Judgement and decision Making
- Building Authentic Relationships
5
Senior Quality Assurance Specialist Resume Examples & Samples
- Manage technical transfer to CMO/contract lab to ensure they comply with regulations and Shire policies
- Monitor QA activity to maintain and ensure job quality
- Audit CMO/venders to ensure manufacturing and QC activity meet guidelines and regulations
- Evaluate GMP protocol/report and report to stake holders
- Periodically review all GMP/GQP SOPs and record to meet cGMP
- Effectively manage and maintain Document Center
- Provide and update QA documents (SOP, records etc)
- Implement staff training, pre-evaluation of CC, prepare GMP inspection, pre-review printing materials, self-audit, TQA update, take meeting minutes
6
Senior Quality Assurance Specialist Resume Examples & Samples
- Ensure that the Quality System is compliant with the relevant current medical device regulations in Canada, the United States, Europe, and Australia and compliant with the quality system requirements of the Corporation
- Ensure that products have the required medical device premarket clearances and licenses to be sold in these markets
- Provide subject matter expertise, interpretations and training on applicable medical device regulations
- Minimum 5 years of experience in the medical devices, pharmaceutical or other life sciences industry
- Working knowledge of medical device regulations in Canada, United States, Australia and European Union
- Certified Quality Auditor, Certified Software Quality Engineer, or Certified Quality Manager recommended but not required
- Regulatory Affairs Certification (R.A.C.) from Regulatory Affairs Professionals Society (RAPS) recommended but not required
7
Senior Quality Assurance Specialist Resume Examples & Samples
- Bachelor's Degree in Scientific, Engineering or Technical Field
- Knowledge of FDA/QSR requirement and quality systems
- Pharmaceutical experience
- Knowledgeable of statistical techniques and application experience
- Demonstrated project management and leadership skills,
- Strong Computer and Information Technology Skills
- Experience interacting with external agency audits
- Training and experience in validation and auditing
- Certified ASQ CQE and/or Lean Six Sigma Green belt
- Training in problem solving tools
8
Senior Quality Assurance Specialist Resume Examples & Samples
- 45% Perform thorough batch record review and release in an efficient and timely manner; assure non-conformances are properly investigated and explained, and calculations are correct. Review finished product packs and batch documentation and check against the registered specifications prior to market release or advising rejection of a batch. Ensure Shire release documentation for each batch is accurate and filed post release according to procedures. 15% Track and evaluate any investigations or deviations that occur during the manufacture of GMP material. When the non-conformance is more serious, escalate to management and aid in requesting a plan of action for a more extensive investigation
- 15% Assist with ensuring change control requirements are met, reviewing and approving action items as appropriate
- 10% Perform review of master batch records according to procedure
- 5% Ensure Product Master Files and Product Information Files are up to date
- 5% As appropriate, represent Quality on project teams, assist in internal GMP audits and regulatory inspections regarding Shire products
- 5% Ensure contractor status for each product is up to date
- Bachelor’s degree in chemistry, biology or a related discipline or equivalent
- 5+ years Quality Assurance experience supporting the manufacture of drug product
- Good working knowledge of US cGMPs, EU cGMPs and familiar with other International GMP standards e.g. Health Canada, ICH, and experience applying the knowledge to batch record review and release decisions
- Complete understanding of quality systems
9
Senior Quality Assurance Specialist Resume Examples & Samples
- University degree/college diploma or equivalent work experience
- 3 to 5 years of related experience
- Good knowledge of standard desktop applications used by the business unit
- Strong knowledge and understanding of the business unit’s key products and services, processes and controls
- Strong understanding of the business unit’s risk and regulatory requirements
- Strong knowledge of departmental systems and applications
- Strong investigation skills
- Good change leadership skills
10
Senior Quality Assurance Specialist Resume Examples & Samples
- 45%: Provide QA support for the manufacture, packaging and release of clinical trial materials. To assure drug product, documentation, and data related to the manufacturing, packaging, labeling, and testing of clinical drug and biologic products are compliant with GMP, SOP, IND / IMPD, CTA and other relevant regulatory requirements
- 25%: Provide QA guidance for product development projects from Phase I - III. Serve as Clinical QA representative on development CMC teams. Support technical transfer and phase appropriate validation for clinical materials
- 5%: Perform compliance audits of external partners for the manufacture of clinical medicinal products. Manufacturers may include API, Drug Substance and Drug Product (biological, medical device and diagnostic kits) contract manufacturing organizations
- 5%: Support CMC preparation documentation and review IND, IMPD and other technical documents for regulatory agency submissions for both clinical and commercial products. Liaise with regulatory agencies as needed to ensure business/regulatory timelines are met
- 5%: Review of QC data and CoA approval. Review and approval analytical methods, clinical stability protocols and reports
- 15%: Review and approval of GMP documentation including but not limited to: master and executed batch records, deviations, change control, CAPAs, OOS investigations, product complaints, Quality agreements, development reports, stability protocol/reports, product specifications
11
Senior Quality Assurance Specialist Resume Examples & Samples
- May require professional; technical; or company certification(s); depending on job assignment
- Certification from the American Society for Quality Control (ASQC) in either Quality Engineering or Auditing. In lieu of certification; require Ten (10) years Quality Assurance background with SUBSAFE and LEVEL I systems
- 5-8 years of related quality assurance testing and/or inspection experience
12
Senior Quality Assurance Specialist Resume Examples & Samples
- Manage quality activities on multiple projects
- Review and approve the contractual quality requirements and ensure the integration of these requirements into the project deliverables and documents
- Determine the Quality objectives for each project, based on the specific project/customer requirements
- Plan, write, implement and maintain the overall Quality Assurance Plan for assigned projects
- Assess the Quality health of projects throughout the Project Life-cycle and report any risks to project stakeholders
- Compile and analyse quality assurance metrics and proactively report negative trends to project stakeholders
- Monitor design, development and testing processes to ensure quality objectives are met
- Supervise or conduct Quality Assessments
- Plan, conduct and supervise audits and qualification of Third Party Software and Services Suppliers
- Identify quality issues and ensure corrective actions are tracked and completed in a timely manner and provide solutions for the elimination of adverse trends
- Interface with the Customer’s Quality Assurance Representative and other authorities whose mandate is the Assurance of Quality
- Generate and maintain assigned project schedules and budgets
- Supervise and coach junior staff members
- Lead and Conduct various process and quality related investigations, as required
- Provide effort estimates for quality engineering work
- B.Sc. in Electrical or a graduate in Software Engineering and/or significant experience in Quality Assurance
- Previous experience in Rail Signaling is an asset
- Strong interpersonal, communication and negotiation skills, including the ability to deal professionally with difficult individuals and problematic situations
- Excellent written skills, to ensure a proper level of professionalism with respect to correspondence to clients
- Self-motivated individual capable of working independently with minimal supervision, who is also a team player
- Strong organizational ability and problem solving capability
13
Senior Quality Assurance Specialist Resume Examples & Samples
- Provide continuing support for development, implementation and maintenance of the Pharmaceutical Quality System and supplier management program
- Provide support for management of complaints, deviations, CAPA's and change controls associated with commercial products
- Preparation and compilation of quality metrics for monthly report
- Support preparation activities for review of the PQS and management review
- Support in the preparation of annual reports, annual product reviews and core documents. Supplier qualification and internal quality review
- Investigating out-of-trend/specification (OOT/S) reports
- Supporting development projects
- Bachelor's degree in chemistry, biology or a related discipline is desirable
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
- Thorough understanding of quality systems and GMPs
- Experience working with contract manufacturing sites or virtual manufacturing is advantageous
14
Senior Quality Assurance Specialist Resume Examples & Samples
- Provide consultation and perform quality and regulatory assessment for equipment qualifications. Ensure completion of appropriate documentation
- Maintain equipment schedules and documentation
- Support change control activities related to equipment
- Perform quality and regulatory assessment for equipment-related policies and procedures
- May assist with quality and regulatory assessment for assay validations
- Assist and/or conduct internal audits. Ensure completion of identified deficiencies and related documentation
- Develop, organize, and evaluate quality-related metrics
- Assist with documentation requirements of licensing, accrediting, and regulatory agencies
- Assist with coordinating and supporting external audits/inspections
- May assist with auditing and monitoring of external partner labs as appropriate
- Assist Quality Management in other activities as appropriate
- Assist with development and monitoring of quality improvement initiatives and quality metrics within laboratories
15
Senior Quality Assurance Specialist Resume Examples & Samples
- At least 5 years of quality experience in medical device industry or similar environment
- Good understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantage
- Sound working knowledge of ISO13485 is an advantage
- Experience in conducting training and ability to impart knowledge and experience to participants
- Previous experience in conducting internal quality audits
- Computer literacy including sound knowledge of the MS Office Suite of software
16
Senior Quality Assurance Specialist Resume Examples & Samples
- Support, maintain, and further enhance Quality Assurance as related to product quality and overall compliance within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to
- A minimum of a B.S. degree in science/engineering, or related field, with at least 5 years relevant experience in a CMO, CRO, or sponsor environment
- Quality-focused experience with quality systems experience
- Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, and EMA regulations as related to pharmaceutical manufacturing
- Required to travel internationally and domestically, (travel up to 15%)
- A minimum of a B.S. degree in science/engineering, or related field, with at least 5 years relevant experience in a sponsor environment
- Quality-focused experience with both quality operations, document control, and quality systems experience with former function within a manufacturing or testing facility
- Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, Health Canada, Swiss Medic, and EMA regulations as related to pharmaceutical, medical device, and combination product manufacturing
- Strong interpersonal communication skills, able to collaborate successfully and efficiently with internal groups and external Contract Manufacturing Organizations
17
Senior Quality Assurance Specialist Resume Examples & Samples
- Highly involved on the development and continuous improvement of training programs
- Manage customer change notifications
- Assist in complaint management as well as in material review boards
- Host customer and regulatory audits and interacts with all departments in both Milwaukee and Sheboygan locations
- Update site and quality SOP's and draft responses to audit observations
- A minimum of a Bachelor’s Degree in Life Sciences or related field is required
- Focused degree in Chemical Engineering, Chemistry or Biochemistry is strongly preferred
- A minimum 5 years relevant experience is also required
- Knowledge of quality systems and ISO Standards is strongly preferred
- Experience in quality assurance is strongly preferred
- Experience in training/organizational educational programs strongly preferred
18
Senior Quality Assurance Specialist Resume Examples & Samples
- Minimum of five to seven years of progressive experience in a GMP environment required
- Experience in Quality Control preferred
- Working knowledge of GMPs and their application to pharmaceutical manufacturing required
- Ability to work both independently and in a collaborative team setting
- Excellent organizational skills with attention to detail
- Demonstrates appropriate safety consciousness
- This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives
19
Senior Quality Assurance Specialist Resume Examples & Samples
- Define test strategies for products that conform to established process and product standards
- Analyze, define, implement, and execute quality and test related activities according to defined strategies
- Create detailed test designs, prepare test environments, and author and execute manual and/or automated tests
- Seek, suggest, and implement quality assurance and test process improvements
- Become a subject matter expert for teams in quality assurance and test related processes, methods, and tools
- 5+ years of experience in software quality assurance testing or related field
- Previous experience working with SQL (Select, Insert and Data Manipulation statements) is a mandatory pre-requisite
- Experience with website testing
- Experience using issue trackers (JIRA etc)
- Experience gained using a range of testing tools – both manual and automated
- Experience working within a cross-functional and global development and design team
- Knowledge of w3c standards
- Programming and/or database experience would be a distinct advantage
- A bachelors-level degree in Information Technology or associated field
- Ability to deliver and execute high quality test plans in a fast paced, dynamic environment
- Consistent focus on quality and product improvement
- Self-disciplined with strong attention to detail
- Excellent problem solving
- Excellent written and oral communications with experience working in client facing environments
20
Senior Quality Assurance Specialist Resume Examples & Samples
- Reports periodically to QA management regarding quality issues and status of inspection/audit activities
- Experience with software validation and equiptments qualification
- Bachelor’s degree in biology, chemistry, or related field
- Leadership experience within a team environment
- Ability to multitask and work under pressure of multiple projects and deadlines
21
Senior Quality Assurance Specialist Resume Examples & Samples
- Provide the development of project Quality Assurance plan and the implementation of procedures that conform to the requirements of the contract
- Work with senior Quality Assurance staff to provide independent assessments of how the project's process is being implemented relative to the defined process and recommend optimization methods
- Conduct audits and review and analyze data and documentation
- Develop and implement procedures and test plans for assuring quality in a system development environment which supports large databases and applications
- Work with senior Quality Assurance staff to conduct orientations on ISO-based quality training for project personnel
- Identify project contract requirements and establish the necessary ISO quality document hierarchy and components by working with other senior managers
- Utilize MAXIMUS ISO-related documentation standards and tools to assist project team members to actively engage in and develop draft quality documents
- Maintain secure directories for storage and control of draft and final ISO quality documents
- Manage dissemination and training documentation
- Undertake or ensure completion by other project personnel, audits of phone customer service and desk re-reviews of sample cases, as well as develop, maintain and report upon quality data from these audits
- Conduct ISO-based internal audits of project practices
- Convene management committee on a timely basis for routine quality assurance sessions, including resolution of preventive and corrective actions leading to continuous quality improvement and client satisfaction
- Participate in the design, development and programming of the quality assurance reports based on access to the appeal case management system
- Track and ensure continuous use of and response to project quality metrics by each project team and component
- Bachelor's Degree from an accredited college or university required, equivalent experience will be considered in lieu of degree
- At least two (2) years of relevant experience in a quality assurance role required, preferably in a call center, document processing or customer service environment
- At least five (5) years of demonstrable experience in Six Sigma projects, or quality management disciplines (TQM/QM/LEAN) required with certification preferred
- A minimum of two (2) years direct experienced as an ISO Auditor/Lead Auditor required with certification preferred
- PMI Certification for PMP and/or CAPM preferred
- Certifications such as Six Sigma, ISO. PMP, CAPM, or certifications from PMI preferred
- At least five (5) to seven (7) years experience in the healthcare/health insurance industry preferred
- A minimum of two (2) years of experience in quality testing required with five (5) years preferred
- A minimum of two (2) years of direct experience with SharePoint documentation management required to include familiarity with direct posting, editing and automated tool use
- A minimum of two (2) year of experience with Technical Writing experience required with preference given for additional experience
- Reporting experience, including report development and quality reporting, preferred
- Experience with Microsoft Office programs, including Word, Excel and Access, preferred
- Excellent organizational, written and verbal communication skills
22
Senior Quality Assurance Specialist Resume Examples & Samples
- You’ll analyze end user requirements and customer reported defects to design and execute manual or automated test strategies across a variety of architectures and cutting-edge technologies
- You’ll work with Product Design and Engineering teams to advocate for the development of high quality testable deliverables
- You’ll work hand in hand with our development team while being part of a Quality Assurance community
- You’ll design, develops, executes, reports, and debugs functional, mobile, browser, accessibility and localization tests
- Can analyze end user requirements or customer reported defects and design, code, and execute tests across a variety of architectures, mobile platforms, and cutting-edge technologies
- Has independence, self-drive, and creativity
- Has developed new tests and maintained existing tests across multiple platforms and toolsets
- Demonstrated ability to work in a cross functional team
- Experience with Java programming, or scripting languages
23
Senior Quality Assurance Specialist Resume Examples & Samples
- Perform batch records review and product dispositions in support of clinical trials and products registration
- Manage, evaluate and approve Quality System documentation including deviations, change control reports, and CAPAs
- Evaluate document changes for compliance requirements (SOPs, specifications, test methods, etc.)
- Evaluate compliance of completed Manufacturing records (batch records, forms, etc.) and quality control records (test/analytical results)
- Perform QA contract manufacturing oversight activities to ensure required quality standards are maintained
- Collaborate with Manufacturing and Analytical Development to continually improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve minor and major deviations
- Lead or participate as required in investigation to resolve quality issues
- Lead or participate in cGMP compliance audits of suppliers, contract manufacturers, contract laboratories, quality systems
- Support Document Control related processes
- Support and conduct training for employees, as necessary
- Analyze and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations
- Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with functional department for timely completion of corrective and preventive actions recommended
- Serve as the quality operational technical representative on project teams evaluating new documentation processes or systems
24
Senior Quality Assurance Specialist Resume Examples & Samples
- Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements. Activities include evaluating change, communicating change other SMEs and Regulatory within the company, approving, and processing the change
- Develop and execute change control implementation plans as required
- Provide notifications/obtain pre-approvals of change controls to partners where required
- Responsible for generation of client requested changes to CMOs and service providers
- Perform external GMP and vendor qualification audits
- Perform vendor qualification risk assessments
- Write audit reports, and follow up on observation close-outs
- Develop/revise/implement/adhere to Quality Assurance departmental policies and procedures
- Minimum BS Degree preferably in life sciences, or equivalent work experience
- Minimum of 5 years’ experience in the pharmaceutical/biotech industry
- A GMP background is preferred with experience in the manufacturing of GMP products
- Attention to detail with an ability to detect and correct errors / inconsistencies in various types of documents
- Ability to work independently within a fast-paced dynamic team environment
25
Senior Quality Assurance Specialist Resume Examples & Samples
- 70%: Responsible for the Execution Global Quality Standards Process
- Create Gap Analysis tools related to the Global Quality Standards
- Track and report on the status until closure of Gaps to the Global Quality Standards
- Maintain in compliance with Shire’s record policies completed Gap Analysis
- Creation and reporting of a dashboard for Global Quality Standards to the appropriate governance forums
- Work with Regulatory Intelligence to identify possible revisions to Global Quality Standards
- Partner with Technical writer to revise documentation as required
- Support in the creation, drafting, and revision of Global Quality Standards for Shire
- Guide teams in the performance of Gap Analysis activities for new or revised standards
- Review team output of Gap Analysis and propose revisions/corrections as necessary prior to sending to Leadership for approval
- Work with Process owners ensure metrics are developed for systems which will show the health of the Quality System through the standards process
- 15%: Responsible In-Use Monitoring of Quality Standards
- Track and report on remediation commitments from process owners and sites and report on adherence to plan to appropriate governance forum
- Work with the Process Owners to evaluate system metrics and propose improvements based on the Quality Standard program to ensure standards are In-Use throughout Shire
- Act as liaison between sites to help ensure standards are implemented consistently throughout Shire
- 15%: Responsible for Integrations of acquisitions into the Quality System
- Work with Integration teams to evaluate markets and contents of acquisitions Quality Manual and Quality Management system to ensure seamless integration into Shire Systems
26
Senior Quality Assurance Specialist Resume Examples & Samples
- Support, maintain, and further enhance Quality Assurance Operations as related to product quality and overall compliance within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to
- A minimum of a B.S. degree in science/engineering, or related field, with at least 5 years relevant QA or Quality-focused experience in a CMO, CRO or sponsor environment
- Quality-focused experience with sterile injectable products, combination products, or Class II medical devices
- Strong interpersonal communication skills, able to collaborate successfully and efficiently with internal groups and external Contract Manufacturing and Testing Organizations
- Excellent multitasking ability and ability to function in an environment with regularly changing priorities
- Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, Health Canada, and EMA regulations as related to pharmaceutical and medical device manufacturing
- Ability to travel internationally and domestically (travel up to 15%). Ability to travel at short notice and for fluid timeframes is also a plus
- Prior experience with onsite manufacturing of aseptically-filled, terminally sterilized, and/or combination products is highly preferred
- Ability to review and interpret QC data including, but not limited to HPLC, GC, atomic absorption spectroscopy, as well as compendial wet chemistry assays
- Experience with Google Docs and Smartsheet a plus
- Capability to learn additional software applications and hardware capabilities also desirable
- Ability to identify improvement and foster change in a growing, fast paced environment
27
Senior Quality Assurance Specialist Resume Examples & Samples
- Independently reviews and approves master batch records, executed batch records, labels, specifications, and other manufacturing documents for cell banks, drug substance (DS), drug products (DP) under clinical development in compliance with US FDA, ICH and international health agency requirements as appropriate
- Independently reviews and approves executed manufacturing batch records, analytical data, certificate of analysis and associated documentation, including any deviations, investigation reports, and change control related to material disposition
- Coordinates, leads and conducts internal Quality Investigations as well as investigations at contract service providers
- Reviews and approves Change Control, CAPA, DCR requests to ensure compliance with Company procedures, cGMP, and other applicable regulations
- Represents QA and provides support to internal team meetings as needed
- Support vendor and internal audits
- Provides and prepares quality metrics as needed
- Initiates and updates SOPs as required
- Support as Quality Representative for regulatory inspections as needed
- Reviews and approves Validation Protocols and Reports
- 7+ years of Quality Assurance (QA) pharmaceutical experience in a GMP environment preferably in gene therapy
- Excellent working knowledge and understanding of cGMP related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the bio-pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus
- Detail oriented with Quality Assurance background and solid problem-solving skills. Ability to work effectively in a team environment with great organization skills
- Excellent working knowledge of Quality Systems and cGMP standards applicable to product life cycle from development to commercial
- Experience with developing key performance indicators (KPIs) and reporting quality metrics
- Must be an individual with proven initiative and demonstrated accountability in a fast paced environment with high degree of flexibility
- Excellent verbal and written communication and interpersonal skills
- Proficient with computers and word processing software (Microsoft Office products)
- Approximately 10% travel is required
28
Senior Quality Assurance Specialist Resume Examples & Samples
- Assist in internal and external audit programs and prepare reports as required. Participate in the Annual Quality Systems audit program. This may include the preparation of Audit Plans, conducting audits and writing Audit reports
- Assist with Regulatory and Customer audits as required. Assist in preparing audit responses to observations
- Develop and maintain a thorough understanding of cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements
- Review and approve master and production batch records
- Disposition final intermediates and APIs (includes review of all associated documentation)
- Review and approve deviations and investigations. Compile data, prepare and review trends. Identify areas of concern and communicate to management
- Review and approve material release specifications and certificates of analysis
- Review and approve equipment qualification documentation, including protocols and reports
- Review and approve SOPs. Write SOPs as required
- Review and assist in resolving customer complaints
- Assist in resolving quality problems/concerns with quality control and manufacturing personnel
- Routinely apply effective and professional communication and organizational skills to coordinate project activities and ensure timely completion of required tasks. This includes communicating directly with internal project teams and customer contacts
- Participate in self-development activities and training of personnel in other departments, including the review of current literature and industry/news trends
- Perform other related duties as may be reasonably assigned in the course of business
- B.S. degree in Chemistry or related field
- A minimum of five years industrial cGMP experience in an FDA-regulated pharmaceutical environment
29
Senior Quality Assurance Specialist Resume Examples & Samples
- Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audits
- Provide recommendations to Testing Facility and Quality Management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of current regulatory inspection guidance and internal trends
- Participate in corporate compliance assessments/mock-agency inspections of other Charles River sites
- Assist with review and updating of departmental SOPs to reflect current practices
- Assist in updating GLP/GMP training materials and provide/ and document company-wide GLP/GMP training sessions
- Provide support during regulatory inspections, as requested
- Perform qualification audits of subcontractors, as requested
- Perform internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems
- Perform facility and equipment records and logbook reviews
- Conduct process based inspections as deemed necessary
- Provide QA support in the validation of computer programs, controlled rooms, test methods, and manufacturing equipment
- Identify any regulatory risk areas and provide recommendations for corrective actions
- Maintain written and signed records of auditing activities and periodically submit to management and the study director written reports per GLP
- Assist QA management with the collection and reporting of site Quality Metrics via QMS
- Provide recommendations for dashboard analysis and analyze metric data for QMS
- Participate and/or take a lead role in coordination of Quality Assurance projects
- Serve as a representative of Regulatory Compliance on harmonization teams
- Serve as project manager on assigned multi-site projects
- Provide training of Quality Assurance personnel with focus on QMS
- Provide assistance/support with Sponsor visits
- May provide study support as needed
- Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science
- Experience: Minimum of 5 years in a Quality Assurance role
- Certifications/Licensure: RQAP (GLP)
- Other: Experience with Microsoft Office® applications and spreadsheet/database programs such as Access and Excel. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential
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Senior Quality Assurance Specialist Resume Examples & Samples
- Responsible for technical information and regulatory registration/licensing of L-Baxalta / L-Shire products
- Provides support to prepare submission, market applications, variations and post approval reporting obligations and general product lifecycle management
- When requires, interacts with the Ministry of Health for the submission and filing
- Maintains, safeguards, and ensures the integrity and confidentiality of files pertaining to the licensing of pharmaceutical products
- Keeps up to date and ensures compliance with regulatory changes that impact commercialized product
- Provide support to prepare regulatory responses to resolve agency review questions
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Senior Quality Assurance Specialist Resume Examples & Samples
- Effectively manages QA initiatives and projects with support from the Internal Audit Quality Assurance & Methodology – VP
- Responsible for managing and executing the full life cycle of the Quality Assurance Review (QAR) process, including preparing individual QARs for each audit indicating report rating and areas for improvement, tracking improvements through the lifecycle of future audits, critically evaluating audit testing programs and related fieldwork in line with key regulatory requirements to ensure comprehensive coverage, and recommending changes to existing practices to support key requirements
- Apply consistent audit strategy to ensure accuracy, fairness and quality of audits.Participate as a key team member on internal audit QA tasks and projects, having responsibility for multiple areas
- Writes, revises and verifies quality standards and procedures in line with professional guidelines and practices
- Minimum 10 years of Audit experience required
- Minimum 4 years’ experience in Quality Assurance function and/ or proficient with IIA standards
- Financial Services/Banking experience strongly preferred
- Strong understanding and commitment to professional auditing standards, risk assessment, regulations and compliance guidelines (e.g., IIA, GAAP, GAAS, COSO, etc.)
- Ability to work independently and efficiently is required
- Experience with Computer Assisted Audit Tools and Techniques (CAATT’S) a plus
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Senior Quality Assurance Specialist Resume Examples & Samples
- Apply Quality Review standards and follow directions on properly applying ‘yes/no/na’ questions to determine accuracy
- Provide feedback to QA team on attribute enhancements and clarifications
- Participate and/or lead in calibration and rebuttal meetings
- Conduct training of employees both individually or in group settings
- Clearly and effectively communicate quality assurance findings to employees and managers
- Identify trends and areas for improvement and provide input to quality area and manager(s) to enhance training or create action plans to address issue(s)
- Provide input to the development of quality tools to be used in the quality review process
- Captures and inputs information for error analysis and assessment
- Participate when called upon for Corporate Audits, Market Conduct Exams
- Maintain a solid understanding of current productions processes and quality methodology
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Senior Quality Assurance Specialist Resume Examples & Samples
- A minimum of 6 years working experience in a Pharmaceutical Quality environment is required
- A minimum 4 years working in a Pharmaceutical analytical environment (e.g., QC, Analytical R&D, or Stability laboratory) is required
- A minimum of 2 years’ experience in a Pharmaceutical Stability and/or Quality Control operations position is required
- Global Regulatory, Compendial and technical knowledge related to analytical & stability laboratory operations, including Part 11, is required
- The ability to develop and utilize metrics for performance tracking is required
- A general Understanding of laboratory systems/equipment (e.g., IQ/OQ/PQ/CSV) is required
- An understanding of analytical methods (e.g., in QC environment and of validation & transfer requirements) is required
- An understanding of basic statistical principles is required
- Proficiency with Quality Lab Systems for events/CAPA management, change control, document management (e.g., Trackwise, ComplianceWire) is required
- Ability to write and/or effectively review/critique technical documents such as lab investigations with analytical and regulatory content as it relates to laboratory operations is required
- Prior experience with internal/external audits is highly preferred
- This position will be located in Raritan, NJ or Titusville, NJ and may require up to 10% travel depending on business needs. Majority of this travel will be between Raritan and Titusville sites.Quality (Generalist)
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Senior Quality Assurance Specialist Resume Examples & Samples
- Maintains awareness of activities by routine direct observation of testing laboratories. Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support system. Address conditions/practices with appropriate personnel, documents and reports findings to Management
- Compiles and reviews Testing batch records in accordance to cGXP and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
- Compiles and reviews raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, cGLP, 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 Non-conforming events (NCE), Laboratory Investigation Reports (LIR), and CAPA investigations
- Perform timely review of complex study files, such as: Assay Validations, Qualifications, and Viral Clearance
- Leads and participates in Internal/External/Client Audits and Audit response writing
- Lead/Participate in quality and process improvement initiatives, and project teams
- Evaluate and perform trend analysis and report results for quality metrics. Make recommendations and drive implementation based upon findings
- Participates in operations and client meetings as QA representative
- Assists with managing the daily work flow of Quality Associates and Quality Specialists, providing additional guidance as needed on quality decisions
- Assists Management in the training of new hires
- Ability to use judgment as dictated by the complexity of the situation
- Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication
- 4-6+ years experience
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Senior Quality Assurance Specialist Resume Examples & Samples
- A minimum of a Bachelor’s degree (or equivalent degree) in a science or engineering related area is required
- A minimum 4 years of working knowledge and experience in a cGMP/highly regulated, Quality Assurance and/or Quality Control environment is required
- Thorough understanding of Quality Systems Regulations, cGMP/GLP regulations, and FDA requirements for pharmaceutical and/or medical devices is required
- Quality Assurance experience with batch chemical API processes and products; including cGMP batch dispositioning and Q7 knowledge is preferred
- Experience utilizing statistical analysis for trending data and applying outcomes to process improvements is highly preferred
- Experience working with TrackWise and other quality systems is a plus
- This position will be located in Athens, GA and may require up to 5% travel depending on business needs.R&D
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Senior Quality Assurance Specialist Resume Examples & Samples
- As a key member of Shire Pharma Canada ULC QA\QC department, contribute to ensure that Shire Canada is compliant with local GMP and GDP requirements for Medicinal Products and Medical Devices. Contribute to prepare for, host and respond to External and Internal inspections
- Support the effective implementation of Shire Pharma Canada ULC Quality Systems: own local SOPs, and work on CAPA, Deviations, Complaints and Change Controls. Also, execute QC, batch review and batch release activities as required
- Establish relationship and work collaboratively to resolve quality issues with Shire Contract Distributors (CDOs), Distributor partners, Contract laboratories and Customers
- Audit third parties and establish Internal and External Quality Agreement as required with the Associate, QA Director
- Provide Quality support to the local operation, for both the existing business and the new product launches
- Contribute to prepare for, and participate in GMP and GDP inspections for Medicinal products and Medical Devices
- Contribute to provide an assessment of new applicable Regulations on the Canadian LOC, and execute the related CAPAs
- Participate in the elaboration of local SOPs and execute quality activities such as Change Controls, CAPAs, Deviation Investigations, Mock recall, Complaints, etc.
- Perform batch documentation review, confirmatory testing raw data review and QC activities, and determine batch disposition as per Canadian Batch Release SOP. Liaise with suppliers regarding any queries on batch documentation
- Work collaboratively with local CDO(s) and Distributor partners; Handle returns, rejects and destruction; and oversee product rework
- Participate in QTA and Quality review meetings as required with the Associate, QA Director. Prepare the change control for Internal and External Quality Agreement
- Review and Manage temperature excursions and Transport and Distribution deviations
- Support GMP\GDP training program for Shire Pharma Canada ULC impacted personnel
- Maintain and further develop competence in GMP\GDP through regular training, benchmarking with colleagues, and coaching from Subject Matter Experts
- Review and approve artwork for printed packaging materials
- Act as a deputy for Shire Pharma Canada ULC Associate, QA Director
- University degree or degree recognized as equivalent in Science
- Practical experience of at least 3-5 years in the Pharmaceutical Industry, mainly in QA/QC environment
- Experience with suppliers and customers
- Excellent knowledge of Health Canada cGMP & cGDP regulations
- Experience in a global environment (asset)
- Good degree of autonomy, able to work with limited supervision
- Good interpersonal and communication skills
- Able to work across levels and functional and geographical boundaries
- Bilingualism is required - French and English
- Look for practical and compliant solutions to issues
- Understands potential impact and contributes significantly to the resolution of simple or complex issues arising
- Work with numbers of suppliers / products
- Facilitate troubleshooting, and tackle non-routine work and projects independently
- Offers constructive comments and propose improvements and rationalizations to systems, policies and procedures
- Use judgement to assess which information must be referred upwards and what can be handled independently
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Senior Quality Assurance Specialist Resume Examples & Samples
- Thorough understanding of QSR & ISO requirements
- Working knowledge of QA/QC and Manufacturing
- Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential
- Associate's degree a plus
- ASQ certification is preferred
- Work related experience in medical device industry
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Senior Quality Assurance Specialist Resume Examples & Samples
- Manage and mentor QA Specialists in the execution of their tasks & responsibilities. These include: QA estimating & planning, QA reporting & documentation, walkthroughs and inspections
- Execution of integration, white box, functionality, regression, load, performance, asset and acceptance testing
- Intervene and escalate issues when they pose a threat to project quality
- Ensure test documentation & results are maintained for the projects over which he/she has QA management responsibility
- Fulfill all the roles of QA Specialist on projects where he/she is Primary QA
- Organize and chair regular QA status update meetings
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Senior Quality Assurance Specialist Resume Examples & Samples
- 10+ years management experience in a Pharmaceutical Quality environment
- Thorough understanding of quality systems and cGMPs and GDPs
- Quality experience in solid oral and parenteral biotech manufacturing (aseptic or sterile processing)
- High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor)
- Strong technical/QA background to partner with suppliers
- Ability to deal with problems arising, develop and maintain good relationships with third parties
- Logical problem solver
- Coordinator/Completer/Finisher
- Good self starter
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Senior Quality Assurance Specialist Resume Examples & Samples
- Bachelor’s degree in chemistry, biology, Pharmacy or a related discipline
- Experience working in Quality Assurance supporting the manufacturing of drugs, biologics, or devices
- Thorough understanding of quality systems and cGMPs
- Experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
- Experience leading CMO/Vendor audits
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing) and solid oral manufacturing
- Able to work with many organizations / cultures / quality systems
- Ability to understand and write technical reports
- Ability to contribute positively to the continuous improvement of business practices
- Effective decision making
- Critical thinking/ evaluation of complex process problems
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Senior Quality Assurance Specialist Resume Examples & Samples
- Evaluates recorded conversations between the agent and caller using the Sr QA evaluation solution for the program, providing context for ratings
- Evaluates interactions with customers or consumers for all contact center channels in multiple channel programs using the appropriate Sr QA solutions
- Provides accurate scoring according to approved criteria definitions, quality standards and standard operating procedures (SOPs)
- Effectively communicates results to agents both verbally and in written format, providing agents a path to appropriate reference materials for additional guidance
- Answers questions and assists contact center staff utilizing approved SOPs or Knowledgebase tools as reference
- Identifies and communicates call trends with contact center management staff; compiles and verifies statistical reports regarding quality metrics for review by contact center staff
- Responds to and reviews score disputes and escalates appropriately
- Presents training materials to Customer Service Representatives as needed
- Meet and exceed the daily requirement of evaluations. Acts as team player in order for the team to meet Sr QA monitoring workload
- Participates in calibration and joint monitoring sessions and comply with agreed scoring standards
- Complies with all customer/data privacy and security requirements
- Carries out additional quality initiatives as directed
- Handles all other duties as assigned
- 2-3 years training experience, evaluating staff, providing feedback, and coaching staff in a contact center to maintain call quality
- Demonstrated customer service, leadership and team interaction skills preferred Strong typing skills preferred
- Ability to work in multi-task environment
- Ability to prioritize and organize work
- May be required to work off-shift as necessary, to include night and weekend
- Security clearance required – position contingent on ability to obtain moderate risk security clearance
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Senior Quality Assurance Specialist Resume Examples & Samples
- 3 years experience in Pharmaceutical GMP manufacturing environment
- Environmental monitoring programs and testing
- Understanding of aseptic processing requirements (ISO 14644-1 and 21 CFR 211.113b)
- Use of electronic inventory management system for full batch record reviews and product releases
- Use of Quality management system for Change Control, Product Investigations and Regulatory Audits
- Knowledge of GDP requirements of working in FDA regulated GMP manufacturing environment
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Senior Quality Assurance Specialist Resume Examples & Samples
- Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence and other cGXP items, as needed to help minimize laboratory audit findings
- Perform/Support Internal audits as well as help implement resolution of internal/external audit findings
- Review Instrument qualifications to ensure that work is performed as per the procedure
- Review GLP data for adherence to GLP regulations
- Review and verify invalid data and system suitability failures
- Review and close Exceptions under Non-Routine Events, System Suitability Failure and Deviations
- Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
- Track and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
- Support other QA compliance related activities, as needed
- Communicate in writing and in person with laboratory personnel in an intelligent and clear manner
- Diagnose problems, solve simple problems, and suggest solutions to complex problems in professional area
- Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
- Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
- May serve as technical advisor for analysts with regard to QA/QC of data
- Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
- Bachelor's degree in science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- At least three years laboratory experience with knowledge of regulatory requirements
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Senior Quality Assurance Specialist Resume Examples & Samples
- Collaborate with support groups to Investigate, write and close out root cause investigations/CAPAs
- Facilitate CAPA Teams through the identification and formation, CAPA execution, documentation and corrective action implementation
- Review and ensure robust Investigations, write and close out all investigations effectively and timely in accordance with FDA & GMP standards
- Review Company's SOPs related to the quality investigational system and assist with improvement/revisions in a timely manner throughout the lifecycle
- Deliver regular reports to the QA management and Company as required
- Deliver regularly scheduled progress reports to the QA management and Company on all investigational activities, current status, and identified trends
- Implement necessary follow-up verification checks on investigation CAPAs
- Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done; must respond timely to deliver quality investigations and thorough CAPAs throughout the lifecycle
- Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations regularly throughout the lifecycle
- Interact with multi-functional groups inside and outside the Quality Assurance department
- Assist in the development of necessary follow-up verification checks on investigation Corrective and Preventive Action (CAPA} items
- Provide quality data, trending/statistical reports to the Quality Management
- Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations
- Assist in the daily activities and assignments of the CAPA process
- Function as the CAPA Subject Matter Expert (SME)
- Ensure that CAPA Teams are functioning, and that they are meeting scheduled commitments
- Prepare metrics and reports as required by Quality Management
- Prepare CAPA status reports for presentation during Management Review meetings
- Review the CAPA files to ensure completion of all activities, tracking the progress of open CAPAs and maintaining the CAPA files
- Bachelor’s degree (B.A.) from four-year college or university; or MLT with national accreditation; or two to three years related experience and/or training; or equivalent combination of education and experience
- Experience with Corrective and Preventive Actions in a quality system environment
- Experience leading Root Cause Analysis/Investigations in a Medical Device and/or Biologics environment
- CGMP Medical Device and/or Biologics experience both US and other countries
- Experience performing investigations Experience writing CAPAs in a Medical Device and/or Biologics
- Ability to demonstrate analytical thinking skills
- Data analysis and trend chart experience
- Experience working within an aseptic environment
- Manufacturing Environment, Processes and Intradepartmental Linkages
- Additional biology or microbiology experience
- Internal Auditor experience
- Conducting training sessions or other mentoring experience in a positive manner
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Senior Quality Assurance Specialist Resume Examples & Samples
- Works with Product Design and Engineering teams to advocate for the development of high quality testable deliverables
- Works hand in hand with our development
- Estimates Level of Effort (LOE) for test/script development, test execution, and other activities central to their assigned tasks
- Collaborates with other team members and with staff on other teams and departments. Interfaces with senior EP staff and offshore staff to provide and review assignments, provide and receive training on feature functionality and test development techniques, and participates in quality reviews of test plans and scripts
- Can represent and advocate for EP with other members of the Product Development team for the purposes of joint triage of defects, reporting test results, and making overall product quality assessments
- Communicates progress and escalates issues to management in a timely manner
- Has independence and self-drive, creativity, and basic programming skills
- Experience in developing test tools to improve productivity of test development and execution in a SaaS architecture
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Senior Quality Assurance Specialist Resume Examples & Samples
- Write, monitor, execute and evaluate application tests using industry standard automated testing tools
- Maintain automated test scripts to meet software release deliverables, project testing requirements and other quality assurance considerations
- Create scripts to compare and validate data results from testing
- Set up data, tools, and databases to support integrated test environments
- Create and execute release and upgrade automation test plans
- Mentor and assist members of QA staff with converting manual test plans to automated test scripts
- Apply test methodology and product knowledge in the design of tests and testing strategies
- Conduct root cause analysis of identified defects, providing sufficient details to understand, replicate and resolve the defect
- Bachelors in Computer Science/Engineering or related field strongly preferred
- Minimum of 7 years of experience in the software industry
- Experience (minimum of 5 years) designing and developing automated test scenarios
- Strong Test automation experience (minimum of 5 years) with at least two of the following tools: QTP, Selenium, TFS Test Automation, SoapUI, SilkTest, LoadRunner, NUnit and custom test tool
- Experience with performance or load testing preferred
- Experience with C# and API testing preferred
- Experience with automated test data generation (red gate, etc.) a plus
- Familiarity with build/deployment automation and continuous integration highly desirable
- Experience testing (minimum of 5 years) applications based on a multi-tier architecture .Net environment. Cloud experience is desirable
- Proficient in MS SQL database and MS SQL Scripting
- Ability to manage multiple projects at one time, often with changing requirements as needed
- Must be detail oriented, reliable and have the ability to work both in a team environment and alone with minimal direction and supervision
- Good interpersonal, written and oral communication skills
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Senior Quality Assurance Specialist Resume Examples & Samples
- Minimum of 5-7 years of progressive experience in a GMP environment required
- Minimum of 5 years of Quality Assurance experience in support of GMP production required
- Previous exposure to investigations and product complaints required
- Must be able to interpret applicable standards and objectively make decisions
- Demonstrated ability to stay abreast of trends and new information in the profession
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Senior Quality Assurance Specialist Resume Examples & Samples
- Investigate customer complaints and non-conformance issues through to resolution
- Track/Manage status /record keeping for complaints, non-conformances, and corrective and preventive actions
- Assess adequacy of quality system documents (including, but not limited to policies, processes, procedures, work instructions, reference material, and forms)
- Design (new) and draft revisions of quality documents
- Evaluate adequacy, interpret, and implement quality assurance standards
- Plan, initiate, conduct, and document internal audits
- Track and analyze data related to quality system metrics
- Prepare reports to communicate outcomes of quality-related activities
- Support maintenance of the document and records management processes
- Support efforts to maintain and continually improve ongoing compliance with overall quality and industry regulatory requirements
- Bachelor’s degree, preferred
- Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma, a plus
- Strong computer skills including Microsoft Office applications
- Knowledge of ISO 9001 and/or ISO 14001, a plus
- Internal auditing experience, a plus
- Experience with implementation of corrective action programs, a plus
- Experience with electronic document management system, a plus
- Experience with work-flow based quality management system software, a plus
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Senior Quality Assurance Specialist Resume Examples & Samples
- You have a solid theoretical background with an engineering or business degree, or equivalent preferably with quality management focus
- You possess solid experience in quality management systems and as lead auditor, exhibiting good auditing skills in a matrix organisation
- You have worked with quality concepts such as root cause analysis, cost of quality, QC tools and continuous improvement tools and methodologies
- You possess good skills in analysing data, and you have a flair for IT, especially Excel and SharePoint
- You speak, read and write Danish and English fluently
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Senior Quality Assurance Specialist Resume Examples & Samples
- High School Degree or equivalent experience is required
- Seven years of related experience is required. No supervisory experience required
- The Quality Assurance Specialist must be able to assess compliance to standards for Mechanical, Electrical, Composite Structures and Electromechanical Assemblies in a highly technical Aerospace Environment
- Must have a working knowledge of Aerospace Quality Systems per AS9100 and/or ISO-9001
- Must have a valid Driver’s license
- Must have a current US Passport
- Must have knowledge of Microsoft Word, Excel and PowerPoint
- 25% travel is required
- Knowledge of Subcontracts including Statements of Work, Performance Specifications
- Must have a basic knowledge of reading engineering drawings
- Must be able to interact with Engineering and Quality Management personnel at Aerospace suppliers
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CT Senior Quality Assurance Specialist Resume Examples & Samples
- Manage onsite Clinical Trial client audits from start to finish
- Manage audit CAPA response process to meet client expectations and deliverables
- In follow up to client audits, track and initiate effectiveness checks for ACM corrective and preventive actions
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Senior Quality Assurance Specialist Resume Examples & Samples
- Assists in performing Software Testing providing software reviews and feedback for business requirements, wire frames, and other design documentation from a QA-based standpoint
- Participates in the Business Analysis / Quality Assurance Task Force and complete action items as assigned
- Provides up-to-date status reporting to Project Managers (PM) and Business Analysts (BA)
- Participates in release management and implementation readiness together with the development team based on testing results
- Works with the technical development team during the defect resolution process including working closely with the BA and PM during re-testing and validation
- Assists in producing defect reports to ensure developers have the required information needed for defect remediation
- Creates testing strategies and detailed test plans to thoroughly confirm desired functionality and utility
- Advises Sirius clients on best practices and methods for an enterprise-worthy QA program
