QA Specialist / Senior Specialist Resume Samples

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P Wunsch

Petra

Wunsch

985 Yundt Cove

Detroit

+1 (555) 731 1262

985 Yundt Cove

Detroit

Phone

p +1 (555) 731 1262

Experience Experience

Phoenix, AZ

QA Senior Specialist

Phoenix, AZ

Mraz and Sons

Phoenix, AZ

QA Senior Specialist

Development and maintenance of the Documentation Management System
Provide QA presence and oversight for Materials Management
Manage materials returned from contract sites
Review Quality parameters and make changes whenever necessary in consultation with Operations
Execute department owned Supplier Change Notification Projects
Initiate and assist with investigations for material defects
Contribute to the development of new concepts, techniques, and standards

Dallas, TX

GCP / Senior GCP QA Specialist

Dallas, TX

Schaden and Sons

Dallas, TX

GCP / Senior GCP QA Specialist

Knowledge of drug development, study design, data and trials management, procedures and documentation practices
Works with cross-functional teams to provide GCP advice
Participates in cross-functional teams providing guidance and risk based options
Assists in the creation and maintenance of audit tools
Receives guidance from GCP QA senior colleagues and management
Provides support during regulatory inspections and internal audits
Maintains good working relationships and communication with GCP customers and GxP QA audit staff

present

Dallas, TX

Product Development & QA Specialist, / Senior

Dallas, TX

Metz Inc

present

Dallas, TX

Product Development & QA Specialist, / Senior

present

Responds to and manages consumer inquiries
Analyzes and develops major projects and carries projects through to completion
Reviews products for taste and appearance in conjunction with the Product Development team
Reviews and/or compares information/data and makes determination within defined guidelines, parameters, and instruction
Compiles information and data from various sources for specific departmental reports, graphs and data comparisons
Maintains complex records and files, searches and investigates information found in files
Posts records and processes departmental documents requiring specific knowledge of functional area

Education Education

Bachelor’s Degree in Science

Florida International University

Bachelor’s Degree in Science

Skills Skills

Ability to create , manage and improve complex quality systems, integrating with existing systems
Ability to work effectively in a fast-paced environment meeting challenging timelines and milestones
Ability to meet challenging timelines, in spite of obstacles
Ability to multi-task in a dynamic environment with changing priorities
Strong organizational skills
Demonstrated teamwork and mentoring skills are essential
Adherence to domestic and international GMP regulations, cGMP’s, company policies and DNA leadership capabilities
Demonstrates unwavering ethics and respect for all customers while evoking Shire leadership values and qualities

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15 QA Specialist / Senior Specialist resume templates

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ExO QA / IC Senior Specialist Resume Examples & Samples

Lead and supervise Quality inspectors and/or auditors
Provide direction to direct reports towards meeting customer requirements
Ensure issuance of corrective and preventive actions (capa) plans and implementation and completion thereof until close-out
Perform quality control (qc) inspection of products and take final decision of batch release
Report and investigate any product non conformance
Analyze product consumer complaints and ensure root cause analysis (rca) is performed with third party manufacturers (TPM)and Coty CRS system/team
Act as Manufacturing Tech Support (MTS) and support the TPM batch industrialization process and pilot making at the site
Ensure corrective actions is being taken on defective products and components
Audit TPM’s and product as needed
Work on quality improvement projects, launches, etc as needed
Provide guidance on quality issues with production, component suppliers and TPM’s
Monitor certification processes for components and finished goods
Perform chemistry tests such as pH, viscosity, RI & specific gravity on raw materials, mass & finished goods
Write/revise standard operating procedures for chemistry area
Maintain product mass specification sheets
Test and approve color cosmetics and perfumes
Responsible for approval of raw materials, mass and finished goods
Test consumer complaint samples submitted to the laboratory
Troubleshoot chemistry issues
Responsible for calibration and maintenance of test instruments (i.e. viscometer, pH meter, refractive index)
Maintain various laboratory databases
Release products in ERP once approved
Assist in training of laboratory personnel
Maintain mass retains
A successfully completed Bachelor’s degree at a minimum, auditing certification a plus
Minimum 5 years of relevant experience in international cosmetic or pharmaceutical industry specifically in good manufacturing practices (GMP) quality assurance
In depth understanding of the cosmetic industry and European and US legal requirement, knowledge of ISO 22716 a plus
At least 5 years’ experience as a batch chemist, knowledge of industrial chemistry is a must
Knowledge in Over-the-Counter (OTC) FDA requirements per CFR is a must
Committed to deliver results
Able to travel abroad as required
Takes intelligent risks when appropriate
Keeps up with new developments in their field
Demonstrates a commitment to growth and self-improvement
Strong communication and negotiation skills
Excellence in Execution
Organized in Action

Senior Specialist Mobile QA Resume Examples & Samples

Mobile app release management and corporate app store operations
Managing the mobile test systems
Supporting project teams to setup mobile test scenarios
Testing of new developed mobile apps and services
Support the 3rd level support team to troubleshoot problems
3+ years of experience in mobile device application testing (iOS or Android)
Experience in testing L4-L7 products such as web proxies, firewalls and web-based applications
Experience in developing apps in iOS and Android is a plus
Experience with Linux/BSD operating systems with knowledge of shell scripting
Experience with mobile device management tools like XenMobile, MobileIron, etc. or similar tools a plus
Knowledge of relational database systems (MySQL, PostgreSQL, Oracle)
Familiar with defect tracking systems and test management tools
B.S in Computer Science or related field
Passion to create a desirable mobile workplace for employees

QA Senior Specialist Resume Examples & Samples

A minimum of a B.S. degree in science or engineering with at least 5 year’s relevant experience executing, developing, and/or administrative GMP quality programs in cGMP biotech and/or pharmaceutical environments
Ability to create , manage and improve complex quality systems, integrating with existing systems
Ability to work effectively in a fast-paced environment meeting challenging timelines and milestones
Excellent interpersonal and negotiation skills required
Demonstrated teamwork and mentoring skills are essential
Demonstrates unwavering ethics and respect for all customers while evoking Shire leadership values and qualities
Judgment and Decision Making

QA Senior Specialist Resume Examples & Samples

Lead QA role for internal Single Use Processes
Ensure that practices are consistent with quality and regulatory standards
Support plant validation and engineering activities and quality systems (QA role)
Serve as a point of contact with Engineering, Facilities, and Capital Projects to identify project needs and ensure appropriate resources are available in projected timeframes
Serve as subject matter experts on internal QA policies, plans and procedures
Participate on Shire Technology Transfer teams to support product tech transfers into Shire US manufacturing plants; ensure seamless handoff to Plant QA Management

Senior Specialist, External Pharm QA Resume Examples & Samples

40% To assess and support GMP compliance for analytical topics (validation and transfer of analytical methods, setting of analytical specifications for the product filing(s)) to maintain compliance with the principles of GMP as required by regulatory filings as well as regional or national laws and guidelines. This includes
Review and approve protocols, reports, test methods and specifications
Be knowledgeable about the methods supporting release of drug product and API
Provide support, communication, and leadership regarding technical information and queries
Actively participate in project meetings as required (including transfers, validation/revalidation activities, process improvements, QA projects)
20% To establish and maintain close working relationship with Shire analytical laboratories through supplier improvement programs, regulatory inspection support and providing GMP support to sites
10% To ensure that Technical Agreements are established, maintained, implanted and revised regularly with Shire analytical laboratories
10% To support execution of QMS and resulting related documents (including applicable complaints, deviations, investigations, etc) to ensure compliance is achieved and maintained
10% To assess GMP compliance with Shire analytical laboratories through audits to ensure effective Quality Systems are in place to maintain compliance with the principles of GMP as required by regulatory filings as well as regional or national laws and guidelines
5% As applicable, provide QA support to other QA groups and new business opportunities including new product introduction and line extensions), to ensure supplier management aspects are covered and potential quality issues are identified and reported to Senior Management
5% Support maintenance of Shire electronic systems to ensure compliance is achieved and maintained
Degree in Chemistry, Pharmacy, Biology or other related scientific discipline
Practical experience for at least 6 years in the Pharmaceutical Industry in manufacturing/technical/QA or QC role, including at least two years analytical experience
Good working knowledge of US cGMPs, EU cGMPs and familiar with other International GMP standards (e.g. including but not limited to Health Canada, ICH, PIC/S, Japan)
Experience applying the knowledge to client and supplier management, including audits and technical agreements
Demonstrate success in working and leadership actions in multifunctional teams

Senior GMP QA Specialist, Qualified Person Resume Examples & Samples

Act as Qualified Person for Investigational Medicinal Products (IMP) and API. In this role acts independently having functional responsibilities for the QP activities
Interact with Regulatory authority to ensure compliance to cGMP
Provide QA support to CMC areas in Aptuit (Verona) Srl
Facilitate the creation, implementation and maintenance of GMP Quality Systems within Verona GMP Areas
Provide QA support to Verona API, PD e QC on GMP regulatory issues
Act as Qualified Person for Clinical IMP batches and API according to the duties described in
Deputy Responsible person for Controlled Drug
Number of years of experience: at least 2 years as a QP

QA Design Assurance Senior Specialist Resume Examples & Samples

Ensure that high quality products are designed, engineered and manufactured by Agilent, in conformance with customer requirements, required standards and regulations
Support Deviations, Nonconformances, CAPA’s requiring Design Assurance input/approval
Support, if needed, external audits (partner, regulatory)
May initiate and support Quality Management Systems (QMS) improvements within area of responsibility
Provide expertise, guidance and training within area of responsibility to the organization
Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance
Education: Bachelor’s or Masters degree or equivalent work experience
Versed in Quality System Standards (ISO13485, FDA CFR 21 820) and IVD/Medical Devices legislation in EU and USA
Business oriented and a desire to work in a dynamic and adaptable environment
An effective communicator at all levels, both internally and externally

QA Senior Specialist Resume Examples & Samples

Administration of the CAPA system including evaluation and close-out
Development and maintenance of the Documentation Management System
Administration of Change control system including assessment
Administration of the internal and external audit program
Development of site training curricula, training material and SOPs for the site training program
Authoring, review and approval of QA related procedures
The successful candidate will hold a BSc in life sciences or pharmacy
A minimum 7 years QA experience in a biopharma environment
A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
Sound experience of regulatory processes and requirements for FDA, EU and global markets
The candidate must be able to work across a team matrix in order to meet accelerated timelines

Senior Specialist Product QA Resume Examples & Samples

Uses tracking and trending techniques on the product complaint system
Support multiple investigations, risk evaluations, customer communications and field actions. Review output of database using standard reports to determine aging cycle of incidents and document discussions and meeting outputs on specific incidents
Requires phone contact with customer sites, interfacing with others within company, and preparing reports using Microsoft programs such as Excel and Access
Review and approve Level 2 and Level 3 complaint investigations reports to ensure compliance to SOP (standard operations procedures)
Working knowledge of Federal Regulations (not limited to 21 CFR 806, 21 CFR 820, and Medical Device Reporting Guidelines) and understanding the consequences of product issues on product performance, customer acceptance, customer risk, and compliance
Implements and maintains the effectiveness of the quality system
Analyzes quality reports generated by the QA specialist and detects and specifies the source of trends and determines the appropriate course of action to resolve identified issues
Uses authority to remove barriers that block goal attainment; influences others to support the identified course of action; takes personal responsibility to resolve issues
Organization of the Medical Event Review Committee
Medical Device Report filings and maintenance of database for support of internal and external monthly reports
Other miscellaneous duties as may be assigned
Typically requires 4-6 years of relevant work experience
Undergraduate University Degree (4 year program) in Engineering, Science or a closely related discipline desired; or equivalent experience
Intermediate working knowledge of MS Office
Knowledge and prior experience with ISO standards and guidance documents and the FDA Quality Systems regulations is desired
Knowledge of complaint handling and field requirements is desired
Prior experience in the medical device and/or in-vitro diagnostic industry is desired
Understanding the consequences of product issues on product performance, customer acceptance, customer risk and compliance
Ability to work independently and in groups; ability to work cross-functionally

QA Senior Specialist Resume Examples & Samples

Review and Disposition of raw material lots per BioMarin SOPs
QA inspection of incoming GMP materials
Raw material lot disposition in EBS
Provide QA presence and oversight for Materials Management
Manage reserve sample program
Inspect incoming reserve samples; perform annual reserve sample inspection
Manage materials returned from contract sites
Review and approve pre-weigh kit control batch records, as applicable
Initiate and assist with investigations for material defects
Execute department owned Supplier Change Notification Projects
Other duties as assigned to support QA oversight of Novato Warehouse operations
Minimum of 4 years of directly related experience in pharmaceutical/biotech quality or manufacturing
Experience with cGMP manufacturing materials control (i.e. inspection procedures, disposition, inventory management)
Demonstrated ability to work independently
Working knowledge of PC software, including Microsoft Outlook, Word, and excel
Experience with ERP systems (such as Oracle e-Business Suite) and/or LIMS preferred

QA Senior Specialist Resume Examples & Samples

Providing Operational floor management by monitoring service levels, making appropriate decisions and regular monitoring of quality
Preferably Senior Quality Assurance Specialist specializing in Customer Service and with strong Sales and Technical background specifically in handling accounting software
Past experience of projects and implementations

Senior Product QA Specialist Resume Examples & Samples

Independently complete and maintain complaint and risk evaluation documentation in a timely manner and in accordance with business standards
Independently execute tasks. ensure compliance to Standard Operating Procedures (SOPs)
Participate on cross-functional teams to support organizational goals. effectively influence others to support course of action
Other tasks and duties as assigned
Understand and comply with applicable EHS policies, procedures, rules and regulations
Responsible for implementing and maintaining the effectiveness of the Quality System
Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices
Understanding of the consequences of product issues on product performance, customer acceptance, customer risk and compliance
Ability or aptitude to work on complex problems/issues
Ability to influence without authority
Demonstrated initiative and problem-solving skills; critical-thinking skills
Ability and aptitude to use various types of databases and other computer software; - ability to prioritize and multitask
Ability to quickly gain knowledge, understanding or skills and is willing to learn

Senior Healthcare QA Specialist Resume Examples & Samples

Provide quality reports to management and attend client meetings
Conduct audits on associates performance, including a percentage of other QA associates work
Maintain audit documentation for their assigned clients and assist with specialized audits and outside audit coordination
Assist associates in multiple locations
Responsible to ensure departmental policies and procedures are written and up to date

Senior Global QA Chemisty Manufacturing & Controls Specialist Resume Examples & Samples

Represent Product Documentation for major regulatory submissions and provides Module 3 (Quality documentation) approvals for assigned projects
Prepare the Quality Overall Summary (QOS) for assigned projects
Collaborate with Regulatory Affairs on the strategic approach to creating Module 3 documentation for the submission
Ensure that authors obtain Module 3, adequacy of content, and level of detail as the quality documentation SME
Ensure project teams and management are aware of project status with regard to Module 3 documentation and QOS progress
B.S./B.A. degree in a scientific discipline or equivalent education/training
Minimum 8 years’ experience in biotech/pharmaceutical quality, compliance, regulatory affairs, manufacturing, or development
2-3 years’ experience preparing documentation for regulatory agencies
Requires broad knowledge of biotech/pharmaceutical product life cycle and manufacturing (e.g., product development, fermentation/cell culture operations, purification operations, fill/finish/packaging, distribution, validation)
Proven technical writing abilities including ability to edit the work of others and provide constructive feedback
Proven ability to collaborate across functional boundaries and provide strategic guidance in the preparation of quality-related regulatory documentation
Proven ability to manage complex projects, consistently meet deadlines, and escalate project road-blocks
Thorough knowledge change control processes for regulated industries and potential impact of regulatory documentation to future license maintenance
Participation and/or support of regulatory inspections, preferably with direct interaction with inspectors or presenting a topic to the inspection team

Senior Specialist Audit QA Belgium Resume Examples & Samples

University degree in sciences
15 years of experience of which 10 in pharmaceutical / Biological environment covering various area: QA, production, QC with managerial
Strong knowledge of regulatory and GMP regulations (European, US, Japanese, WH0 ...)
Demonstrated leadership ability and experience in influencing improvement activity to ensure implementation of appropriate CAPAs
Familiar with Lean/Six Sigma tools
Qualified / Certified auditor is a plus – demonstrated lead auditor skills
Communications skills to ensure issues, risks and opportunities are well understood and that effective actions are put in place
Fluent in French and English ( written and spoken )
Demonstrated ability to function effectively across a complex organization
Knowledge of technologies used in the (bio)pharmaceutical business
Organize and lead transversal GMP audits within the Belgium organization - commercial activities

Senior Manual QA Specialist Resume Examples & Samples

Test front-end of application
Create and execute test cases/checklists
Experience in manual testing of applications over 3 years (functional and non-functional)
At least upper intermediate level of spoken and written English

QA Senior Associate / Senior Specialist Resume Examples & Samples

Review Analytical Documentation such as specifications, project notebooks, cleaning validation reports, method validation protocols, etc
Audit relevant documentation for regulated projects and communicate observations to Project Leaders
Release raw materials and packaging components for clinical trial use
Lead deviation and product quality investigations using effective root cause analysis methodology
Manage CAPAs, Change Controls, OOS and Laboratory Investigations to timely closure
Review and issue new and revised SOPs, test methods, and protocols
Assist in working on continuous improvement projects
Perform internal Quality System audits
Support sponsor and regulatory authority audits and inspections
Bachelor’s Degree in Chemistry, Pharmaceutical Science or related field
Minimum of 5 years of experience in a Quality-related field within a pharmaceutical environment
Excellent knowledge of cGMPs and strong commitment to Quality and Safety
Ability to work both independently and in a team-oriented, collaborative environment, and the willingness to work with others to solve problems
CDMO/CRO experience
Understanding and application of FDA regulations in wide variety of Quality aspects
Experience with Clinical Trial supplies manufacturing
Experience leading continuous improvement projects
Experience with batch record review
Experience leading internal audits and issuing audit reports
*This role does not offer relocation***

Product Development & QA Specialist, / Senior Resume Examples & Samples

Responds to and manages consumer inquiries
Executes product quality reviews against product specifications as applicable
Prepares product preparation directions for accuracy verification
Generates consumer recipes to support private label product packaging and social media
Reviews products for taste and appearance in conjunction with the Product Development team
Reviews and/or compares information/data and makes determination within defined guidelines, parameters, and instruction
Maintains complex records and files, searches and investigates information found in files
Compiles information and data from various sources for specific departmental reports, graphs and data comparisons
Posts records and processes departmental documents requiring specific knowledge of functional area
Completes detailed keyboarding projects
Analyzes and develops major projects and carries projects through to completion
Researches and interprets a variety of levels of information
Maintains unit documents such as ledgers, financial records, service information, regulatory, etc
Coordinates and implements approved changes in policies and procedures affecting unit

QA Specialist / Senior Specialist Resume Examples & Samples

Conduct QA audits of BIO laboratories and functions including, but not limited to: ongoing process, data review audits, technical report, and study independent facility / process
Maintain appropriately detailed notes, audit reports, and records Effectively report quality issues to supervisor, Study Director, and management, as appropriate
Assist the Director with Client audits and regulatory inspections Oversight of Master Schedule
Implementation, maintenance and enhancement of quality procedures and systems to ensure compliance with US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and publications
Providing input to method, equipment, computer validation programs.Providing input to documentation and data storage systems
Ensuring that requirements and documentation for all regulated systems are kept current according to changing guidelines and industry standards
Providing regulatory training to staff as necessary. Providing oversight and input to investigations and CAPA, as appropriate
Conducting outside vendor audits as may be required, including laboratories and services for subcontracting and/or supporting services, and follow-through on any quality issues
Reviewing and maintaining Standard Operating Procedures (SOP)

Senior GLP & GCP QA Specialist Resume Examples & Samples

Working knowledge and understanding of GLP and GCP regulations; US required, EU desired
Direct auditing experience (ability to travel approx. 20%)
Strong GCP and GLP experience
Ability to work effectively in a team environment with great organizational skills
Possess effective interpersonal, verbal, and listening skills
Ability to analyze and reconcile moderate to complex issues independently

GCP / Senior GCP QA Specialist Resume Examples & Samples

Plans, conducts and reports on GCP audits of clinical investigators, vendors, systems plus key reports and documents
Participates in cross-functional teams providing guidance and risk based options
Reviews study documents and checks for consistency and appropriate standards and practices
Supports the internal audit process with regards to documents and compliance
Provides support during regulatory inspections and internal audits
Assists in the creation and maintenance of audit tools
When appropriate, prepares and/or revises GCP SOPs and Work Instructions
Represents GCP QA on appropriate teams to facilitate audit planning
Supports comprehensive internal GCP training programs
Works with cross-functional teams to provide GCP advice
Receives guidance from GCP QA senior colleagues and management
Maintains good working relationships and communication with GCP customers and GxP QA audit staff
Ability to travel 35% per month
May be required to perform additional duties as needed
1-2 years’ experience in GCP QA (3-4 years for Sr. GCP QA Specialist)
Experience working with clinical trial pharmaceutical regulations and guidance
Demonstrates experience conducting detailed internal and external audits of clinical studies, vendors, data and reports
Solid understanding of regulatory inspection processes
Understands Clinical SOPs, department controlled documents, GCPs and regulations
Knowledge of drug development, study design, data and trials management, procedures and documentation practices
Proficient in word processing, spreadsheets and database software
Effective planning, organizational and interpersonal skills
Ability to present complex information clearly and logically
Able to work in a fast paced environment while handling multiple demands and shifting priorities
Coordinates projects to successfully meet timelines
Flexible and willing to adapt in a changing environment
Proficient in word processing, spreadsheets and database software applications on a PC, specifically MS Office: Word, Excel and PowerPoint