Senior Specialist, Quality Assurance Resume Sample
Irving Walker
16573 Helena Rapids,
Phoenix,
AZ
+1 (555) 544 5094
Work Experience
Senior Specialist, Quality Assurance
05/2018
-
PRESENT
Philadelphia, PA
- Plans, leads and executes audits to verify execution of the technology strategy to help ensure that MRL systems, software and instruments meet MRL standards and regulatory requirements. Facilitate the implementation of the necessary processes and controls to achieve the strategy
- Provide proactive input and support to project teams, functional areas and system owners to help ensure quality and regulatory requirements are considered in technology design and implementation
- Provide proactive input and support to project teams, functional areas and system owners to help ensure quality and regulatory requirements are considered in technology purchase or design and implementation
- Leads assigned teams in the prioritization of batch release pending inventory needs and schedule adherence; performs routine assignments supporting final product release
- Develops competence by performing applicable work assignments
- Receives a moderate level of guidance and direction from others
- Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
- Tier attendance with applicable updates and communication escalations, as applicable
Senior Specialist Quality Assurance
08/2012
-
04/2018
Phoenix, AZ
- Function as Associate Director representative, in their absence, when required
- Review and edit content of learning materials to ensure clarity and consistency
- Check the quality of all deliverables and ensure that errors are corrected
- Actively seek opportunities for continuous improvement initiatives
- Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity
- Participate in quality focused teams across Moderna’s broad ecosystem of functions
- Authors and reviews SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations
Senior Specialist, Quality Assurance Ait
04/2010
-
06/2012
Los Angeles, CA
- Oversee and review executed electronic batch record documentation
- Develop batch records, SOPs and training materials for startup of the Norwood Facility
- Oversees execution of corrective and preventative actions (CAPA), deviations and change controls in support of the personalized vaccine unit
- Closely partner with peers for rapid disposition of personalized cancer vaccines
- Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review
- Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data
- Practice safe work habits and adhere to Moderna’s safety procedures and guidelines
Education
Upper Iowa University
2004 - 2009
Bachelor's Degree in Science
Professional Skills
- Strong verbal and written communication skills ; Prior experience in quality remediation activities
- Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management
- Demonstrated attention to detail and excellent oral and written communication skills
- Proven organizational, critical thinking and problem solving skills
- Deliver results through proven analytical aptitude, critical thinking skills, and ability to apply key concepts
- Strong leadership skills for the ability to lead teams of a cross - functional and multi - level nature, including senior management representatives
- Prior experience in Quality Risk Management, process and system validation, and change control
How to write Senior Specialist, Quality Assurance Resume
Senior Specialist, Quality Assurance role is responsible for leadership, excel, interpersonal, conflict, computer, negotiation, analytical, word, integration, retail.
To write great resume for senior specialist, quality assurance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Specialist, Quality Assurance Resume
The section contact information is important in your senior specialist, quality assurance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Senior Specialist, Quality Assurance Resume
The section work experience is an essential part of your senior specialist, quality assurance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous senior specialist, quality assurance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior specialist, quality assurance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Specialist, Quality Assurance resume experience can include:
- Strong understanding of cGMPs, EU, USDA, and EPA regulatory standards, including biologics or vaccine experience
- Performing review and approval for investigations, CAPAs, QCTS commitments, change requests, risks, IQ/OQ/PQ, validation, Master Batch Records (MBRs), etc
- Independent and flexible worker that can readily adapt to changing priorities in a fast-paced, cutting edge environment
- Work with 3rd party testing labs ensuring services are effective and appropriate
- In-depth working knowledge and/or experience with managing a Quality system and site Quality Council
- Direct experience with managing or investigating customer complaints or deviations
Education on a Senior Specialist, Quality Assurance Resume
Make sure to make education a priority on your senior specialist, quality assurance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior specialist, quality assurance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Senior Specialist, Quality Assurance Resume
When listing skills on your senior specialist, quality assurance resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical senior specialist, quality assurance skills:
- Proven global problem-detection and problem-resolution skills required
- Possesses strong conflict resolution and negotiation skills
- Strong conflict resolution and negotiation skills required
- Experience authoring, reviewing, or contributing to Annual Product Reviews or extensive technical writing experience in a GMP environment
- Demostrated analytical, problem-solving and communication (oral/written) skills are required
- Able to work effectively as an individual with minimal supervision and as a team member
List of Typical Experience For a Senior Specialist, Quality Assurance Resume
1
Experience For Senior Specialist Quality Assurance Resume
- Fluent in English (oral and written); strong communication and organizational skills
- Experience in process validation or production and process controls
- Manage and build skills and capabilities in Quality Key Element Owners and Quality Functional Leaders
- Strong knowledge of microbiology testing
- Strong working knowledge of MS Office software
- Assist in the development, implementation and management of an electronic system to maintain and track site qualification activities in a validated state
- Experience with quality management systems, and information system development and implementation
- Closely collaborates with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place
- Independently prioritizes activities in support of multiple projects
2
Experience For Senior Specialist Quality Assurance GMP Resume
- Knowledge of equipment/process validation/qualification activities
- Review and approve controlled documents and records, e.g. SOP, Validation, Master Batch Review, analytical test records, batch records
- Preparing and submiting release protocols to CBER. Preparing CoAs to support regulatory filings
- Writing, reviewing, and approving SOPs and other instructional documents for shop floor
- Providing training to incoming personnel and ensures compliance with departmental procedures
- Performing GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements
- Working knowledge of HACCP, GFSI and Quality Management Systems and their application in food industry
3
Experience For Senior Specialist, Quality Assurance Ait Resume
- Working knowledge of cGMPs, GLPs
- Scheduling of inspection activities
- Working knowledge of HACCP and GFSI and its application in food industry
- Straightforward practical way of thinking about things or dealing with problems,
- Participate in quality oversite of manufacturing through real-time observations of activities
4
Experience For Senior Specialist, Quality Assurance Resume
- 16) Presenting system overviews to regulators as needed
- Perform Quality Assurance manufacturing batch record review
- Responsible for disposition of incoming production materials
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
- Assist in the development and management of the site qualifications monitoring and oversight process of authorized hospitals
- Manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
5
Experience For Senior Specialist Quality Assurance Resume
- Perform a quality and regulatory review of product quality data for products being added to the Medical Distribution master file
- Manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions
- 15) Assists in training new Quality Assurance Specialists
- Review and approve sub-contractors procedures and ITP’s or designate them to responsible persons
- Write and review GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
- Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
6
Experience For Senior Specialist Quality Assurance GMP Resume
- Draft, interpret and implement quality assurance policies and procedures
- Evaluate adequacy of quality assurance standards, review the implementation and efficiency of quality and inspection systems
- Collect and compile statistical quality data, analyze data to identify areas for improvement in the quality system
- Meet with CFDA and local FDA regulators
- Work as a coordinator between distributor and Integra China to ensure compliance
- Coordinate adverse event reports and recall notifications to Authority and maintain internal records
- Coordinate with regulatory department to ensure the approved Chinese IFU and labels meet CFDA regulatorions and are included with products before customer receives products
- Work closely with the local Commercial team and the Logistic Partner to ensure records of IFUs & Labels are kept, conduct and monitor routine testing and inspection of materials and products to ensure finished product quality
7
Experience For Senior Specialist, Quality Assurance Ait Resume
- Travel 10-20% of time
- Customer Quality Contact for Toll Process and Industrial Customers
- Owns Food Safety (HACCP/Preventive Controls), and Food Quality (HACQP) systems
- Change Control Owner for Quality
- Own Proficy items related to Process Quality
- Bulk transportation Quality owner
- Food Safety Preventative Controls QI
8
Experience For Senior Specialist, Quality Assurance Resume
- Food Defense Coordinator for the site
- Core member of Quality Audit team
- Recall and Traceability team member
- Process Controls Quality owner
- Accountable for analytical equipment service contracts
9
Experience For Senior Specialist Quality Assurance Resume
- Member of Food Safety (HACCP) HACQP/Food Defense Team
- 2) Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site
- 3) Providing Quality oversight of supplier information across all categories of suppliers that service WP. Provide quality input for assessing risk associated with use of specific suppliers, audit results, etc
- 4) Manage Supplier Management system by processing / approving changes and auditing system data as appropriate
- 5) Serve as Quality subsystem owner / subject matter expert for relevant Quality system(s)
- 8) Performing and coordinating Product Quality Complaint/Adverse Event activities including PQC intake, handling sample returns, investigations, and compilation and analysis of PQC and AE data
10
Experience For Senior Specialist Quality Assurance GMP Resume
- Supporting the preparation of regulatory filings
- 9) Working within the Change Control System to ensure requirements are met. Running IPT Advisory Council meetings
- 10) Performing review and approval of automation changes
- 11) Providing Quality oversight for Deviation Management Program
- 12) Performing review and approval of deviations
- 14) Performing internal audits
- Author, review, and approve Annual Product Reviews / Product Quality Reviews
- Manage Supplier Management system
List of Typical Skills For a Senior Specialist, Quality Assurance Resume
1
Skills For Senior Specialist Quality Assurance Resume
- Work experience in a pharmaceutical, biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field
- Computer skills; knowledge and competency in ERP/MES, Trackwise, PowerPoint, Excel and Word
- Direct experience supporting Regulatory inspections and Regulatory reporting
- Experience with leading Fact Finding meetings or Technical reviews
- In-depth working knowledge of current Good Manufacturing Practices regulations
- Direct experience working with SAP, LIMS and /or TrackWise in a GMP environment
2
Skills For Senior Specialist Quality Assurance GMP Resume
- In-depth working knowledge and experience with application of GMPs
- Past experience interacting directly with regulatory or third party auditors
- Accountable for the development of risk assessments on raw materials and finished goods to determine appropriate testing protocols
- Analytical Equipment experience/troubleshooting
- Experience conducting internal/external audits
- An understanding of the FDA Good Laboratory Practices
- Previous experience in quality control, quality assurance, auditing or regulatory affairs
- Previous experience in auditing or Agency inspections
- Experience in pharmaceutical/ biotechnology or related industry, including 2 years in Quality Assurance
3
Skills For Senior Specialist, Quality Assurance Ait Resume
- Executes review and approval of qualification documentation including Validation, IQ, OQ and PQ documents
- Operations, Quality Control, Quality Assurance and/or cGMP experience
- Prioritize audit sections based on CMC’s request
- Project Management, Change Execution Management experience in a Quality function
- Previous vaccine experience (in one or more of the functional areas described above)
- Strong integrity led value system
4
Skills For Senior Specialist, Quality Assurance Resume
- Review validation protocols and reports to ensure compliance
- Monitoring of performance through tracking and trending to ensure compliant operations
- Authoring/approving Annual Product Reviews
- Authoring supporting documentation for Annual Product Reviews (APRs)
- Performing and coordinating Product Quality Complaint activities
- Working knowledge of CCPSA, TSSA and Quality Management Systems and their application in consumer products
- Coaching of Quality Functional Leaders
- Coaching of Analytical Experts
- Responsible to managing customer complaints including identifying trends and driving resolution and year over year sustainable improvement
5
Skills For Senior Specialist Quality Assurance Resume
- 6) Coordinating BPDR/FAR activities, including oversight of the BPDR meeting
- 15) Participating in regulatory inspections, including facilitating and RMT activities
- Prepare quality operations metrics by gathering and analyzing manufacturing and quality data in production
- Releases raw materials and packaging components for use in processing
- Knowledge of distribution and handling of products within Manufacturing, Supply Chain and Retail Environments
- Straightforward practical way of thinking and problem solving,
6
Skills For Senior Specialist Quality Assurance GMP Resume
- Provide QA leadership during investigations involving incident management
- Manage vendor scorecards including reporting to business and vendor community
- Lead commercialization and CQV (commissioning, qualification, and verification) for new and existing product initiatives with little to no supervision
- Participate, as necessary in current IT project workshops as a SME relating to product quality data, hazardous materials shipping, storage programs, etc
- Create and deliver training programs relating to QRA topics
- 1) Authoring and Reviewing Annual Product Reviews (APRs)
- 7) Coordinating Fact Finding, Recall Committee, and Market Action activities
- Perform product and process quality training; determine and establish the required procedures for controlling product and process quality
7
Skills For Senior Specialist, Quality Assurance Ait Resume
- Review of sterility confirmation/growth promotion testing of laboratory media and sampling
- Provides support to Production and QC activities by ensuring released media and raw materials are available, including weekends as required
- Collaboration across IPT functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
- Capable of providing input within the department and cross functional teams
- Have knowledge of distribution and handling of products within Supply Chain
- Conduct vendor risk assessments for new and current vendors and make recommendations in accordance with our Vendor Operating Standards
- Maintain brand integrity by upholding the safety and quality brand standards
8
Skills For Senior Specialist, Quality Assurance Resume
- Work with suppliers to implement corrective actions to reverse negative trends in manufacturing related consumer complaints
- In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
- Provide support for testing protocol creation
- Manage testing reports, their evaluation and any applicable CAPA
- Participate in Artwork and Label creation to ensure testing requirements are identified and claims requirements are understood by all parties
- Provide input during product specification reviews and follow-up on action items as required
- In-depth working knowledge and application of GMPs / GLPs in biologics and/or vaccines
- 3) Is knowledgeable of site GMP procedures and is capable of interpreting intent and requirements within them
9
Skills For Senior Specialist Quality Assurance Resume
- 4) Stays abreast of emerging general GMP industry trends
- Interact with vendors (product and packaging) to create package systems compliant with DOT regulations for hazardous materials shipments
- Provide support for Medical Distribution field personnel relating to QRA topics and product quality data
- Lead and support teams of a cross-functional and multi-level nature, including senior management representatives
- Work history in laboratory testing used in clinical trials
- Fundamental understanding of GCPs/GLPs
10
Skills For Senior Specialist Quality Assurance GMP Resume
- Fundamental understanding of CAP/CLIA certifications
- Independent decision making capability and ability to think conceptually and understand impact of decisions critical
- Identify training needs and organize trainingsto meet quality standards
- Support local Marketing, Sales and TSR to resolve QA issues or potential post-market QA issues
- BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and
- Quality training system owner
- Provide coaching to plant operations on quality systems and day-to-day quality issues
- Lead capital projects pertaining to quality
- 13) Providing Quality Leadership and oversight for risk management across the Site
List of Typical Responsibilities For a Senior Specialist, Quality Assurance Resume
1
Responsibilities For Senior Specialist Quality Assurance Resume
- 19) Provides validation support with the approval of IQ/OQ documents, performance qualifications, and validation documents
- Experience in the FDA regulated pharmaceutical or medical device industries
- At least one year of food science or QC experience is required
- Laboratory, quality, or other related experience is required
- Managing aspects of the material control and/or release process as it relates to control of material for deviations and risk processing
2
Responsibilities For Senior Specialist Quality Assurance GMP Resume
- Participate in preparation for external audits and provide support during audits as needed
- Author, review, and approve quality agreement with both internal and external partners
- Coordinating and executing all Quality Operations activities to ensure production plans are met, utilizing the tier process. Supports project work in the building
- Actively participating in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative
- Participate in site CAPA activities to facilitate CAPA completion in a timely manner
- Participate in the implementation of Quality Assurance procedures and process improvements to ensure the quality of the product(s); collaborate with cross-functional teams to fulfill the Quality Assurance function and support cGMP compliance
- Work with manufacturing to determine quality attributes and requirements for incoming, equipment, validation, software, material and process used in production; identify manufacturing quality gaps or problems; perform basic root cause investigations and facilitate solutions
- Perform on site audits of TPMs and local suppliers as they apply
3
Responsibilities For Senior Specialist, Quality Assurance Ait Resume
- Provide day-to-day support and oversight to operations and engineering to address issues and questions in accordance with Quality Systems requirements; provide prompt support to address urgent items
- Help investigate, conduct tests or experiments, gather data and perform preliminary analysis; report findings; prepare and communicate recommendations and respective action plans with respect to complaints and repair
- Knowledge of regulations and standards affecting medical devices, including quality assurance for product release in cGMP environment
- Technical background in Engineering or related scientific field; Certified Quality Engineer or Auditor desired
- Knowledge of risk analysis such as FMEA, Hazard Analysis, SPC, DOE, etc
- Travel; up to 40% travel required
- Complies with all FDA, SQF, and Company food safety and quality policies
- Drive continuous improvement in the quality programs
- Support operations with quality issues
4
Responsibilities For Senior Specialist, Quality Assurance Resume
- Coordinate preparations for all internal and external quality audits
- Manage Quality Control lab functions
- Monitors HAACP/Food Safety Plans daily paperwork and outages
- Manage Kosher, Acidified, Non-GMO and Organic Programs
- Assist Quality Control Manager with the allergen program
- Evaluates Hold items for disposition
- Maintain sanitation procedures and programs
- Manage the Prodika formulation system
- Proficy system super user
5
Responsibilities For Senior Specialist Quality Assurance Resume
- Member of Product Recall team
- Back up plant Quality Control Manager
- Responsible for release activities for site manufactured drug product
- Review and approval of executed batch records
- Provide oversight of QA shop floor program
- Issue production batch records and product labels to Operations
- Assist in change, development and management of the Apheresis Collection Application System
6
Responsibilities For Senior Specialist Quality Assurance GMP Resume
- Assist with document change requests, change control, deviation and CAPA systems
- Collaborate with cross-functional departments to ensure timely implementation of quality records
- Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations
- Coordinate and/or support the preparation of procedures, processes and quality improvements
- Assists in the coordination of significant quality events including fact finding, investigation support, coordination of clinical quarantine and recovery actions
- Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business
- Five (5) to seven (7) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas
7
Responsibilities For Senior Specialist, Quality Assurance Ait Resume
- Represents Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance
- In room and back room support during the inspection
- Interactions as SME with auditors/inspectors during internal/external GMP audits and regulatory inspections
- Support an environment of teamwork and staff development and learning
- Provide support and release of internal and external manufactured sterile drug product
8
Responsibilities For Senior Specialist, Quality Assurance Resume
- Maintains an expert level of knowledge relative to GMP requirements and industry trends as described in applicable worldwide regulations. Provides guidance and interpretation of GMP, regulatory, and compliance standards
- Provides Audit (Divisional, PAI) and Agency Inspection (Health Authority) support for preparation and execution activities, as needed
- Proactively identifies, develops and implements opportunities for work/process improvement and efficiency
- Pre-inspection contract with agencies and third parties
- Logistic coordination for inspections
- Documentation of the inspection activities
- Communication of inspection outcomes
- Lead or support site level audits at the WP site
9
Responsibilities For Senior Specialist Quality Assurance Resume
- Participate as guest auditor at non-WP site audits
- Maintain current on cGMP practices
- Identify and remediate risks through the site audit process
- Support the site shop floor audit program
- Independently manages projects associated with customer complaints and develops systems in support of new product introductions
- Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective action
- Creates/presents information to Senior level management to recommend the need for regulatory agency notification/market action
- Participates in policy development activity both locally and with MMD compliance experts externally
10
Responsibilities For Senior Specialist Quality Assurance GMP Resume
- Interprets Merck Quality policies, GMPs, and other agency regulations for application to the Wilson site
- Complaint and production investigation root cause analysis and corrective action identification
- Policy/procedure development and interpretation
- Review and approval of GMP-related SOPs
- Lead and facilitate compliance projects to support new product introductions
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