Mgr, Quality Assurance Resume Samples

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L Hartmann

Lacey

Hartmann

70570 Erdman Wall

Detroit

+1 (555) 851 6999

70570 Erdman Wall

Detroit

Phone

p +1 (555) 851 6999

Experience Experience

Chicago, IL

Quality Assurance Mgr

Chicago, IL

Nienow, Wiegand and Braun

Chicago, IL

Quality Assurance Mgr

Drives Continuous Improvement efforts in product quality/performance and process optimization
Assists the Plant Manager in managing local, state, customer/third party, and federal audits and inspections
Engages in the typical responsibilities of a manager requiring planning, evaluating, organizing, integrating and delegating
Contributes implementation of Quality Management System and Standard Procedures per ICH Q10 and PAL; to include Information Systems and GMP Procedures
Possesses a working knowledge of sanitation systems, techniques and procedures
Manage and have the fully oversight of local contract secondary packaging facility
Manage GxP system (CAPA, Change Control, Deviation, Self-inspection, Training, Complaint, Recall, etc.)

Houston, TX

Mgr, Quality Assurance

Houston, TX

Feest Inc

Houston, TX

Mgr, Quality Assurance

Develop and maintain key quality metrics for functional area, as tool for continued improvement
Partner with Operational Excellence to support the development, maintenance and adherence to quality systems and continuous process improvement
Establish and implement standardized testing methodologies and tools designed to improve the quality of I/S products and services
Supervises Quality Assurance personnel to include routine job assignments, performance reviews, training opportunities, and associate development
Responsible for establishing and maintaining an environment that encourages teamwork and collaboration
Provides technical assistance and direction to the other functional groups
Provides technical support to R&D for new product development

present

New York, NY

Mgr., Quality Assurance

New York, NY

Ruecker-Lang

present

New York, NY

Mgr., Quality Assurance

present

Develops staff through feedback, coaching, counseling and support
Performs cGMP training for both new and existing staff as it relates to 21 CFR part 111
Ensures accurate and timely completion of all tasks relating to issuance of Batch production records and maintenance of cGMP and SOP records
Please note in our facilities there will be risk to specific Allergens including shellfish and other materials.
Leads, anticipates, assesses and manages current and future compliance on the manufacturing floor
Supports goal setting, administers performance appraisals, and conducts interviews for new candidates
Facilitates and presents data and information pertaining to quality performance to upper management

Education Education

Bachelor’s Degree in Nursing

University of Central Florida

Bachelor’s Degree in Nursing

Skills Skills

Maintains awareness of the business context and company profitability, including budgetary control issues
Broad knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for pharmaceutical or medical device operations
Broad knowledge of pharmaceutical manufacturing operations and related quality principles
Knowledgeable in GMP audit processes
Working knowledge and/or experience in Aseptic Processing/Terminal Sterilization Pharmaceutical Manufacturing
Proficient in the use of both personal and mainframe computers including a wide variety of word processing and spreadsheet software packages
Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations
Defines quality procedures in conjunction with operating staff
Excellent verbal and written communication skills (English)
Promotes quality achievement and performance improvement throughout the organization

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Mgr-business Analysis & Quality Assurance Resume Examples & Samples

3-5 years of previous leadership experience
Minimum 4-6 years Business Analyst Experience or Quality Assurance Testing
Experience managing teams responsible for performing BA and QA roles on the execution of multiple projects on a large scale ($1 Mil + in budget) containing multiple lines of implementation stakeholders (Development teams, 3rd party software vendors, etc.)
A sound understanding of the SDLC, Requirements gathering, Quality Assurance, and Testing automation
Experience creating and tracking Team metrics and associated output as appropriate for varying levels of communication
Ability to work with technical teams and lead discussions around system implementation details
Ability to work in a fast-paced, dynamic environment
Strong Customer Service Skills with the ability to partners well with all levels of stakeholders
Collaborative approach to decision-making on teams
Strong analytical and problem solving skills with a high attention to detail
Ability to deploy an approach to critical thinking which leverages methodologies
Experience with producing Key Performance Indicators and metric reporting including industry standard and best practice information
MS Office intermediate to advanced skills with Word, Excel, PowerPoint, etc. Excel including Pivot tables, template and graph/chart design and development
Effective Conflict Management and Time Management skills
Strong presentation skills and the ability to articulate the complete and balanced analysis and implications of a solution
Working familiarity with various waterfall and Agile methodologies
Proven ability to work with all members of an extended and diverse project team
Candidate must have mentoring and guidance skills to provide oversight and direction to contractors and junior members of the team
Adhere to the Credit Union’s core values and The Walt Disney Company’s Four Keys while consistently modeling integrity and respect in carrying out the PFCU’s mission and vision
Ability to occasionally work a flexible schedule, including nights and weekends
5-7 years Credit Union or Financial Industry experience with broad knowledge of Credit Union operational experience
Strong knowledge of unit testing, behavioral testing and continuous integration
Strong knowledge of Business requirements gathering and documentation techniques
Strong application performance / tuning skills
Understanding of importance of maintainable / sustainable product solutions

Mgr-business Analysis & Quality Assurance Resume Examples & Samples

Experience with XML, CSS, Javascript, JQurey
Experience with HTML, HTTP, SSH, FTP
Experience with TFS
Knowledge of Networks, Operating Systems, Internet Product and Services, Java applications, and Tomcat
Knowledge of Content Management Systems
Knowledge of Internet Safety and security standards

Workcell Quality Assurance Mgr Resume Examples & Samples

Recruit and maintain high-caliber work force for QA function for the workcell
Work with all levels in the workcell and supporting functions to improve product quality performance with ultimate goal of Zero Defect. Ensure all levels of the organization focused on providing the customer with defect-free product and customer satisfaction
Drive to conclusion all action items assigned to the workcell and team members and other supporting functions
Develop, motivate and lead all team members to perform to their full potential, providing direct and timely feedback in formal and informal media, on all issue pertaining to product quality
Monitor and evaluate the level of QEs’ involvement and success on all activities pertaining to product quality improvement; and their contribution towards the continuous improvement of process yields and efficiencies
Provide support to all functions to ensure that appropriate corrective and preventive measures are taken and implemented on a timely basis
Evaluate and schedule training programs and/or seminar for the Quality Engineering team and other functions that required the appropriate knowledge for product quality improvement
Ensure plant wide ESD Controls and Product Regulatory requirements are established and maintained
Maintain positive employee relations with encouragement of Jabil’s open-door policy, suggestion box, participation in status and team meetings, and interactive one-on-one communication
Ensure the responsibility and accountability are very clear; communicate calmly, but clearly, on areas that need improvement. Instill a continuous improvement mentality in all functions within the workcell
Review all relevant policies and procedures with direct reports and within the workcell (related to product quality) regarding the specific application to their assignments. Ensure each individual comprehend, as well as providing them ongoing support to ensure compliance
Foster good morale, a proactive and positive culture, and maximize the opportunity for personal growth within the workcell QA Team
Able to lead and coach all Quality Engineering personnel to enable independence and ownership of their efforts
Develop, motivate and challenge all team members to perform to their fullest potential, providing direct and timely feedback in either a formal and informal media
Prepare periodic performance reviews of all direct reports. Recommend salary increases and changes in job status as appropriate
Create a sense of pride and ownership that strive to be the best in workcell execution and performance
Provide and maintain a safe work environment for all employees and visitors
To extend support to other workcell or functions, upon request from QA Manager and/or senior management, whenever needs arise, for the benefit of the company
Bachelor’s degree in Engineering or related discipline
At least 5 years of working experience in the Quality related field
Proficient and knowledgeable in all areas related to the QA function
Able to communicate clearly and effectively in both verbal and written media

Mgr Quality Assurance Policy Resume Examples & Samples

Represents the interests of Northrop Grumman at industry workgroups, as well as represents the MS sector at corporate-level workgroups and briefings
Provides expertise and guidance in interpreting and applying policies, regulatory and/or government regulations, and agency guidelines to the business area and functional stakeholders
Coordinates analysis, review, and comment of draft and final, prohibitive and restrictive substance regulations, material authenticity, cyber-security regulations, and quality management regulations
Leads the development of multi-department and multi-site product regulatory compliance strategies
Promotes professional development of a team of regulatory and standards and fosters a collaborative culture that sustains the momentum around employee engagement and inclusion, affordability, innovation, value growth and continuous improvement
Provides clear assignments, helps employees connect their efforts to the bigger picture, creates an inclusive work environment characterized by mutual respect and the valuing of differences, and builds a culture that motivates employees to their highest level of performance
Maintains the highest level of commitment to quality, compliance, and internal controls in adherence to company values and ethics
Bachelor’s degree in Business, Law, Engineering, or related technical field
8 years of total experience in law, contracts, engineering, or mission assurance, 4 years of which are in contracts or regulatory compliance
5 years of management experience
Demonstrated ability to lead multi-functional teams
Demonstrated success in disseminating written and oral technical information to various disciplines
M.S. Degree in Engineering, Technical Management, Business, or Law

RN Mgr of Clinical Practice & Quality Assurance Resume Examples & Samples

Registered nurse licensed in the state
Minimum of two years clinical management experience, including the supervision of nursing staff preferred
Minimum of three years hospice, home health or related organization experience preferred

Mgr Asst Quality Assurance Resume Examples & Samples

2 Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes (e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management
5 Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies
7 Maintain clean efficient work environment and ensures sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions
Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR

Mgr, Quality Assurance Resume Examples & Samples

Manages testing staff and works as a member of the team. Ensures onshore and offshore vendors adhere to agreements listed for SLA and provides regular governance to those standards
Implements and maintains a coherent, progressive quality assurance testing strategy
Co-ordinates the activities required to ensure that the product provided is fit for its purpose and meets customer expectations
Monitors and advises on how the quality management system is performing and publishes data and reports regarding company performance against set indicators
Ensures compliance with State and Government standards and legislation
Maintains awareness of the business context and company profitability, including budgetary control issues
Participates in the budgeting process
Defines quality procedures in conjunction with operating staff
Sets up and maintains controls and documentation
Collects and analyzes performance data and charts against defined parameters (i.e. Metrics)
Ensures tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary
Manages automation team in carrying out performance/load tests and checks
Creates ad-hoc technical and management system reports
Liaises with customers and ensures the execution of corrective action and compliance with customers' specifications
Establishes standards of service (Service Level Agreements) for Automation, Manual, and User Acceptance testing in addition to Release Management
Monitors performance through gathering relevant data and producing statistical reports via custom real-time metrics available for all project initiatives in Quality Center
Interfaces with application support, software developers, and project managers to implement best practice testing methodologies
Consults and collaborates with Configuration Management on QA current and future technological needs
Coordinates use of testing environments, including setting priorities and resolving conflicts
Establishes and maintains all environmental integrations for third party/outsourced work into QA environment
Day-to-day management of project automation resources and activities including: identification of new and modification of existing test automation tools/deliverables/processes, assignment and leadership of all test automation activities, oversight of all automation initiatives (and/or defects), sign-off of automation approaches and plans, schedule or quality goals, oversight of all automation documentation, and oversight of the defect assignment and verification processes
Oversees the development of completed, tested, and packaged Automated Testing Scripts for test execution and analysis
Responsible for the development and maintenance of completed, tested, and packaged Regression Test Suites
Preferred A Bachelor's Degree in information systems, information technology, or related field of study
Required 5+ years of experience in Information Technology
Required Other Experience in managing, supervising, or leading others
Preferred Other Experience in the Healthcare Payer industry
Advanced Ability to lead/manage others in a matrixed environment
Advanced Demonstrated leadership skills
Required Advanced Microsoft Word
Required Advanced Microsoft Excel
Required Advanced Microsoft Project
Required Advanced Microsoft PowerPoint
Required Advanced Microsoft Outlook
Required Advanced Microsoft Visio
Required Advanced Other Expert knowledge of quality assurance methodology, system analysis, and large software development
Preferred Advanced Other Exposure to the Agile methodology

Mgr Quality Assurance Ortho Resume Examples & Samples

Develop, establish and maintain QA processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulations
Oversee the documentation process for Device History Records; propose, draft, review and approve new or revised SOPs, job instructions and related forms relative to the quality assurance program or other programs which may impact the quality assurance program
Provide guidance to Operations personnel in interpreting governmental regulations, agency guidelines and internal policies to assure compliance
Direct and supervise daily activities of QA/QC staff involved in receiving, in-process and final inspection, complaint investigation, Corrective and Preventive Action (CAPA) process and document control to ensure compliance to quality standards/regulations
Responsible for hiring and training quality assurance personnel as required supporting the above processes
Generate ideas and leads efforts at the facility to identify root causes of quality issues and implement processes to resolve and prevent issues
Participate in Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities
Facilitate the Change Control Board (CCB) meetings to review and disposition Change Orders (CO)
Lead ISO internal audit, train and develop internal auditors and issue audit reports
Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits
Evaluate employees through performance reviews, ongoing coaching and feedback methods. Analyze and resolve or assist employees in solving work issue. Maintain discipline, morale and team relationship within the QA/QC group
Provide quality data, trending/statistical reports to the RA/QA Director
Maintain quality system in compliance with all applicable regulatory standards (FDA QSR, ISO 13485, MDD, CMDCAS, Canadian Medical Device requirements) and other relevant requirements throughout the facility
Demonstrated ability to lead and manage staff of employees
Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
Ability to prioritize, multi-task and adapt to change
Ability to work within budget constraints and to work with minimal guidance to perform job function
High degree of initiative and self-motivation with a strong sense of accountability
Word processing skills, including Microsoft Word, Excel, and PowerPoint

Quality Assurance Mgr Resume Examples & Samples

Manages the operation of the plant laboratory, including ensuring supplies and equipment are available
Develops, facilitates and maintains the Milk and Juice HACCP program
Provides Customer inputs into iCiX as required, and views/monitors Supplier iCiX postings to ensure all SQF audit requirements are met
Implements and maintains all Dean Foods quality systems (i.e. SQF 2000)
Ensures adherence to appropriate regulations and Company standards for raw milk quality
Communicates quality metric and inspection results to appropriate managers and others in leadership positions including, but not limited to daily, weekly or monthly KPI reporting to Corporate
Assists the Plant Manager in managing local, state, customer/third party, and federal audits and inspections
Engages in the typical responsibilities of a manager requiring planning, evaluating, organizing, integrating and delegating
Familiarity with Good Manufacturing Practices
Union (for union facilities), Safety, and Workers Compensation experience preferred
Ability to follow all Sanitation and Quality Policies and Procedures, and report and follow through on any deficiencies
Ability to follow Continuous Improvement (CI) Processes in the Management Operating Structure (MOS)

Mgr, Quality Assurance Resume Examples & Samples

Leads a team of Customer Experience Interaction Evaluators to drive consistency and stabilization of customer experience core foundational attributes and deployment initiatives across the contact center network. The team is accountable for providing visibility to the quality of the service provided including the QM checklist that gets at soft skills and accuracy and proactively reporting/follow up on any issue/concern they observe about service (e.g., background noise or a complaint about lack of confirmation etc.)
Develop quality standards including the creation and implementation of quality monitoring evaluation methodologies that support improved customer experience efforts across all departments with direct customer interaction
Develop and lead new and continuing quality initiatives including expansion of the quality program organizationally
Prepare actionable reports and feedback to CC operations leaders to enable action
Partner with Training leveraging results from monitoring and other quality initiatives to create or revise training materials to address skillset and knowledge gaps
Identify, develop and implement technology solutions in the support of driving more consistent and frequent feedback to TM’s including such technologies as voice technology for QM processes/analysis
Effectively prepare and communicate customer experience evaluation results for Operations management to leverage in the support of coaching/develop team members
Learn new processes, services and systems and work with the appropriate organizational leaders to customize and/or update QM standards and processes as needed for each supported department
Utilizes the talent management process to hire, develop, and retain top talent, as well as hold individuals accountable and address performance gaps to create the BEST team
Ensure Evaluation Team is trained on all relevant processes and technologies and is considered an expert user in addition adheres to documented evaluation processes, procedures and other Customer Experience and/or business related standard work
Proven experience in design, development and implementation of quality programs in a Contact Center environment
Demonstrated ability to build a high performing team and provide clear direction
Business maturity to support senior leaders
Must be non-biased, discreet and confidential in all work activities
Strong sense of customer service and company strategy, including an understanding of how work aligns to help exceed business objectives
Demonstrated analytical, problem solving and troubleshooting skills with meticulous attention to detail
Demonstrated working knowledge of technology and systems
Excellent written and verbal communication skills, with the ability to communicate effectively with all levels of the organization and in multiple venues
Effectively managed a large (10+) team in a remote multi-site environment
Demonstrated ability to lead through change, both large scale and at the team level
Ability to operate in a complex, rapidly changing environment, and the ability to work independently, and balance and prioritize multiple work requests

Mgr Quality Assurance & Testing Resume Examples & Samples

Deliver Corporate objectives/ projects in a timely manner with respect to Test, Integration, and QA
Partner with development organization to drive Test-Led-Development methodology
Drive, stakeholder, and improve Processes & Procedures promoting efficiencies across Dev/Test teams
Embrace change and inspire /coach team members to adopt automation
Juggle multiple priorities with multiple applications and complex programs
Remain knowledgeable of technological/ methodical modernizations in the Dev/Test domains
Partner with teams to ensure consistency across the organization
Resolve escalations
Provide executive level project information
Assist the engineers in career development, setting and managing expectations, compensation, and provide the active coaching they need to advance their technical, functional and team skills
Bachelor's degree or equivalent education and relevant experience
10+ years related experience, 4+ years leadership experience. 8+ years related experience with Masters degree
Strong Communication Skills
Ability to successfully communicate with executives and their support staff
Excellent written/verbal communication skills, including the ability to succinctly summarize complex issues in layman’s terms
Strong communication and consensus-building skills which enable interaction with partners, business owners and end users
Excellent leadership skills including initiative, teamwork and high emotional intelligence
Strong problem solving, decision-making and analytical abilities
Self-starter with a strong desire to understand and research new technologies
Candidate must demonstrate experience in following an established software development methodology, project development planning and problem resolution
Highly motivated, committed to quality and a strong desire to meet tight timelines
Ability to coach team members through conflict and change
Ability to work with technology, product owners, management and operations
Ability to establish creative solutions and lead team members into new processes and responsibilities
Lead a team in creating a suite of automated scripts using a standardized framework to cover all validation points which have been deemed suitable for automation
Strong experience in multiple technologies
Experience with test automation tools (Selenium, UFT, Scripting, etc.)
Strong experience in Microsoft applications, (Excel, Power Point, etc.)
Experience in the telecommunications industry including knowledge of networks, network equipment, ordering systems, and provisioning systems
Experience in Test Methodologies
Experience in leading change in an organization
Experience in leading cross functional team / solutions
Experience in Agile / Scrum Methodologies

Mgr., Quality Assurance Resume Examples & Samples

Develops staff through feedback, coaching, counseling and support
Performs cGMP training for both new and existing staff as it relates to 21 CFR part 111
Supports and participates in audit preparations and inspections by certifying agencies and regulatory bodies, i.e. USP & FDA
Leads, anticipates, assesses and manages current and future compliance on the manufacturing floor
Ensures accurate and timely completion of all tasks relating to issuance of Batch production records and maintenance of cGMP and SOP records
Leads and/or supports investigations through Root Cause Analysis and effective Corrective and Preventive Action (CAPA). Evaluate data using statistical tools. Lead or actively support Product Change Control
Acts as the subject matter expert in relation to PQM, AQL’s, Deviations, NCR’s, protocols, policies, SOP’s, EMP Center, SharePoint, Oracle, all quality programs
Facilitates and presents data and information pertaining to quality performance to upper management
Develops cross functional and multinational relationships to support interaction with various internal customers
Supports, leads, administers all mock recall activities for the site; is the expert in the area of mock recall, retrieval, and recall
Supports the Quality Manager in daily activities and act as the site lead in the absence of the Quality Manager
Demonstrates leadership through a commitment to communication, work habits and be fully competent in all aspects of a wide variety of processes including maintaining safety, troubleshooting/problem solving, decision making, organizing/planning, NBTY core behaviors, administrative, quality appraisals, sampling plans, manufacturing audits/process audits, statistical techniques, production control systems, manufacturing document review, test equipment and training
Understands SPC and how to leverage data to drive improvements into processes
Partners with Operations team and R&D group to execute and facilitate site initiatives in pursuit of business objectives and targets
Acts as role model of the business vision and mission and have a strong understanding of what it takes to achieve company goals, KPI’s and metrics
Supports goal setting, administers performance appraisals, and conducts interviews for new candidates
Assists and monitors First Pass Quality; lead improvement action plans
Excellent oral and written interpersonal communication skills
Ability to lead, train, motivate, and work within a team
AS400 Knowledge desirable
Must exhibit exemplary behaviors in line with NBTY Inc. principles and values

Mgr., Quality Assurance Resume Examples & Samples

Leads and/or supports investigations through Root Cause Analysis and effective Corrective and Preventive Action (CAPA)
Evaluates data using statistical tools
Lead or actively support Product Change Control
Demonstrates leadership through a commitment to communication, work habits and be fully competent in all aspects of a wide variety of processes including maintaining safety, troubleshooting/problem solving, decision making, organizing/planning, core behaviors, administrative, quality appraisals, sampling plans, manufacturing audits/process audits, statistical techniques, production control systems, manufacturing document review, test equipment and training

Mgr Asst Quality Assurance Resume Examples & Samples

3 Performs center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
4 Review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements
10 Initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented and effective
15 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable
17 Perform other quality duties, as assigned, to support business needs
Experience in regulated environment strongly preferred
Understand Quality Systems and/or regulated training requirements
Learn new processes and quickly engage in assignments to drive for action
Make decisions in accordance with established policies and procedures

Mgr., Quality Assurance Resume Examples & Samples

Minimum of 5 years in the food, dietary supplement or nutraceutical business would be preferred
Strong knowledge of quality control systems, preferred
Knowledge of regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business, preferred
Bachelor’s degree and / or previous experience in a quality leadership role preferably within a manufacturing environment. Exposure to Six Sigma Training preferred
HACCP certification preferred
ASQ CQE or CQM preferred
Knowledge of regulatory and GXP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred
SQF practitioner / FSSC/ BRC/ ISO experience preferred
Limited travel required for this role, 10% or less
Please note in our facilities there will be risk to specific Allergens including shellfish and other materials.**

Mgr, Quality Assurance Resume Examples & Samples

Ensure Quality Assurance Operations and programs are effectively established and maintained according to local, corporate and applicable state, federal and international requirements
Provide strategic leadership of short- and long-term goals through the use of thoughtful techniques in the communication of the company’s mission and core values as a means to implement positive change and/or create organizational structure within Quality Assurance
Serve as official alternate management representative for all regulatory matters and is back up to primary site quality leader for quality operations issues
Provide guidance and technical support for day to day operations, non conformance management, complaint handling, process control, project planning and data analysis
Assures timely and appropriate investigation, communication, disposition and corrective actions associated with product and/or process quality issues
Review and approve as required product, process, and material related nonconformances for technical accuracy, completeness, and justifications supporting recommended actions to be taken
Monitors the quality of products and implements systems and strategies to ensure product quality to established governmental regulations and company specifications. Coordinates the reporting of quality issues to management
Develop and maintain key quality metrics for functional area, as tool for continued improvement
Assures timely and accurate presentation of key Quality performance metrics to plant personnel and leadership team
Responsible for staffing, training, coaching and development of subordinates to maintain and improve product quality and systems consistent with department and company operating objectives. Responsible for the motivation and development of subordinates to optimize their performance and personal and professional growth
Develop/mentor staff on root cause analysis, critical thinking, process improvements, risk based decision making and continuous improvements to process and product
Represent B Braun on quality assurance topics during interactions with regulatory agencies, including interface with FDA inspectors
Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge
Oversee projects to ensure proper company resource allocation and prioritization and adherence to project development schedules
Partner with Operational Excellence to support the development, maintenance and adherence to quality systems and continuous process improvement
Partner with research, product development, operations and regulatory affairs functions to ensure new products meet all necessary requirements. Responsible for the outgoing, safety, quality, and efficacy of all finished products manufactured at the Irvine plant
Responsible for establishing and maintaining an environment that encourages teamwork and collaboration
Interacts with all levels within the organization to manage functional area. Overall responsibility for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations
Ensures that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods
Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization
Broad knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for pharmaceutical or medical device operations
Must be knowledgeable with CAPA, document control, product release, management of external audits, internal audit systems, management review, risk management, validation, design controls, and process development, monitoring and statistical control
Must have experience interfacing with FDA and ability to effectively write audit responses, conduct root cause analysis, and document investigations
Familiarity with requirements for submissions to regulatory agencies
Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages
Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met
Bachelor's Degree or higher in Biomedical or Chemical or Mechanical or Industrial Engineering or an equivalent Science/technical field
A minimum of 12 years of experience in a regulated industry [medical device, pharmaceutical, automotive, aerospace or equivalent]. Experience with manufacturing of large volume parenterals is preferred
Minimum of 7 years of managerial experience
Travel to any B. Braun facility domestic and international

Mgr, Quality Assurance Resume Examples & Samples

Must build relationships and strategic alliances with business partners and Enterprise Systems colleagues to effectively manage and balance multiple system priorities
Must act as a change advocate; a willingness to use leadership, facilitation and interpersonal skills to inspire cultural change and continuous process improvement
Establishes a work atmosphere where team members’ behavior exemplifies and promotes the Grainger Values
Plans and directs the activities of QA Engineers, external contractors, and consultants. Is responsible for hiring, retaining and developing key talent
Responsible for managing the group’s budget. This is includes the planning and managing of department/project capital and expense activities to ensure that financial targets are met
Collaborates directly with business partners, various Engineering areas, external consultants and vendors to assess feasibility, cost/benefits, and priorities to support business initiatives with system solutions
Establish and implement standardized testing methodologies and tools designed to improve the quality of I/S products and services
Orchestrate the Functional and Performance testing required for each software release across all cross process teams
Identify and participate in determining the right technology to address complex testing across multiple systems
Ensures that all software development and testing deliverables are produced prior to the certification of a release
Educate and influences the entire organization to follow and continously improve key testing processes
Create a consistent atmosphere of trust and confidence with various stakeholders across the enterprise
Guide and define approaches to resolving complex problems and barrier removal that aid in the result of timely delivery of project solutions
Maintain a support team with the required skill set to respond effectively to the needs of the business partners. Establish opportunities to cross-train as appropriate to meet minimal support agreements
Manages Employee Talent and Performance requirements by providing individuals with accurate, timely and coaching feedback
Develop and maintain effective external partnerships with key vendors and other thought leaders to benchmark best practices in current technology and business system operations
Identify changes in the technology landscape that can be exploited to create a competitive advantage for Grainger, which can improve upon business operations, or reduce total cost of ownership. Where appropriate, provide recommendation to Enterprise Systems and business leadership to achieve objective
Participate in Enterprise Systems strategy and long range planning activities
Align the team with the strategy and goals of the Company by
Bachelor’s Degree in Computer Science or related area, or equivalent experience
Knowledge of development and management principles and practices
Experience in implementing and executing quality assurance practices as part of the Agile/Lean development process
Well-versed in all testing methodologies (white vs. black box test work, system vs. functional)
Must have a proactive, results oriented attitude, lead by the example of serving others, with a superb work ethic and the flexibility to work within an environment of constant change
Knowledge of human resource management principles and procedures
Experience effectively leading groups of staff
Demonstrated leadership and collaboration skills, and ability to drive/influence change without direct authority
Strong problem-solving and negotiation skills
Demonstrated business knowledge and organizational awareness
Proven expertise managing vendor/supplier relationships, including contract negotiation, ongoing maintenance/support and problem-resolution
Strong verbal and written communication, facilitation, and interpersonal skills
Strong project management skills; experience in organizing, planning, and executing large-scale projects from vision through implementation to include directing internal personnel, contractors, and vendors. Must be able to demonstrate ability to analyze project needs and determine resources to meet objectives,

Quality Assurance Mgr Resume Examples & Samples

Manage and have the fully oversight of local contract secondary packaging facility
Responsible and accountable for all GXP systems related to AABP products
Manage GxP system (CAPA, Change Control, Deviation, Self-inspection, Training, Complaint, Recall, etc.)
Creates QMS and GQP operating procedures per the Pharmaceutical Medical Devise Affairs Law - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices; and small molecules in solid oral dosage form
Contributes to the Amgen-Astellas BioPharma (AABP) mission, vision and strategy
Leading projects such as product launch
Contributes to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
Supports PMDA Inspections with Amgen and AABP colleagues
Quality oversight of Contract Manufactures, Contract Laboratories and Logistic Service Providers as needed
Supports shipment and distribution of Investigational Product and collaboration with Amgen Clinical Manufacturing Site Quality to maintain product quality
Contributes implementation of Quality Management System and Standard Procedures per ICH Q10 and PAL; to include Information Systems and GMP Procedures
Supports Audit program management for key Japanese suppliers to Amgen. These suppliers may include contract laboratories, final packaging materials suppliers and service providers
Contributes the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements
Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities
Demonstrated ability to manage relationship development and maintenance and negotiation skills
Experience performing GMP audits of laboratories that perform analytical testing of biologics, LSPs and packaging suppliers
Pharmaceutical/ Biologics product commercialization and lifecycle management experience
Knowledge of regulatory authority inspection processes
Experience in Japan with multiple language capability (English, Japanese)
Strong verbal and written communications skills in English. Must be able to effectively articulate ideas with same levels of an organization in multiple countries
Self leadership and motivation with high personal integrity and application of Amgen Values in daily operations
Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff
Ability for travel to international destinations as needed
Leadership experience leading teams, projects, programs or directing the allocation of resources
Experience with Japanese pharmaceutical companies
Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan
Experience with Investigational Medicinal Products (IMP) and commercial products
Experience with medical devices in Japan

Project Quality Assurance Mgr Resume Examples & Samples

ASQ, PE, PMP or similar certifications
Industry standards knowledge
Training and leadership experience
Qualified as an auditor ( preferanly lead auditor)
Quality Assurance Program development knowledge/experience

Mgr, Quality Assurance Resume Examples & Samples

Oversees the performance of the Quality Assurance function (“Quality on the Floor”) in support of pharmaceutical manufacturing to assure that products and processes meet company and regulatory requirements
Works through a multi-level team to carry out the necessary quality processes in support a pharmaceutical environment to include
Oversees the review and approval of pharmaceutical batch record information to support commercial release of product
Mobilizes QA resources to drive the investigation of excursions in Manufacturing or other related operations which may result in abnormal operation rejections. Resolves the nature of the anomaly, the overall impact, material disposition and corrective actions
Manages Non-Conformances and Corrective Action Preventative Action (CAPA) initiatives related to pharmaceutical manufacturing and product quality
Reviews and approves protocols and reports to support change controls
Provides technical support to R&D for new product development
Reviews environmental and manufacturing data trending reports and recommends corrective actions
Writes, revises, and approves Quality department procedures
Provides technical assistance and direction to the other functional groups
Interfaces with regulatory agencies in conjunction with new drug submissions and during routine audits, field complaint investigations and technical interchanges to present the company viewpoint
May conduct internal audits to determine any deficiencies in the Manufacturing, R&D and Distribution Operations as they relate to current regulations
Ensures the efficient use of resources in order to achieve department quality and operation plan objectives
Supervises Quality Assurance personnel to include routine job assignments, performance reviews, training opportunities, and associate development
Responsible for staffing, training and development of subordinates and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives
Broad knowledge of pharmaceutical manufacturing operations and related quality principles
Thorough knowledge of GMPs, GLPs and pharmaceutical products
Demonstrated working acumen of pharmaceutical quality systems to include non-conformances, CAPA, change control, validation, batch review/release, and/or environmental monitoring
Knowledgeable in GMP audit processes
Working knowledge and/or experience in Aseptic Processing/Terminal Sterilization Pharmaceutical Manufacturing
Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations
Previous active participation in pharmaceutical Health Authority inspections; preferably FDA
Demonstrated ability to work in a cross-functional team environment to address the quality, technical, and business needs of the company
Proficient in the use of both personal and mainframe computers including a wide variety of word processing and spreadsheet software packages
BA/BS degree in related science and 8 or more years of experience in a pharmaceutical or medical device company, preferably within B. Braun
5-7 years previous quality managerial/leadership experience
Demonstrated experience with pharmaceutical regulatory body interactions and/or inspections
Limited domestic and/or international travel may be required
Management of a large diverse quality team supporting a 24/7 pharmaceutical manufacturing operation

Senior Mgr, Quality Assurance Resume Examples & Samples

Strong analytical and problem solving skills with attention to detail and data accuracy
Experience with interpreting data, identifying trends and seeking out root causes for solutions
Proven track record of managing multiple projects simultaneously with demonstrated ability to meet or exceed deadlines and project goals
Self-motivated, results-driven, able to work with minimum supervision and maintain confidentiality
Strong communication skills with track record of applying rapidly changing technology to complex business needs
Experience working with call center Quality programs and providing multiple avenues for implementation and communication strategies
Ability to lead staff, develop skills and execute on initiatives in a dynamic and fast paced environment
Ability to use and advanced knowledge of personal computer and software applications such as the Microsoft suite of applications (word, Excel, Project, Visio, Power Point)