QA Specialist / Senior Specialist Resume Sample

13 votes

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Julie Mills
4542 McDermott Locks,  Phoenix, AZ
+1 (555) 277 2423

Work Experience

QA Senior Specialist
10/2017 - PRESENT
New York, NY
  • Provide reliable and timely assessment of the level of compliance of products against external and internal requirements
  • Execute audits as per approved plan
  • Act as single point of contact with third party manufacturers for any quality and compliance troubleshooting on Coty products
  • Conduct Industrial Chemistry related testing and liaise between R&D and Quality Department
  • Support the DCs providing technical information required by authorities
  • Audit processes to ensure quality standards are being met
  • Audit TPM’s and product as needed
  • Provide guidance on quality issues with production, component suppliers and TPM’s
  • Maintains a clear understanding and working knowledge of GMP requirements, Safety requirements, and SOP’s. Adheres to and enforces those policies within the team
GCP / Senior GCP QA Specialist
04/2013 - 04/2017
Philadelphia, PA
  • To Improve Quality. RFT (Right First Time)
  • To improve Quality – PPM (Parts per Million)
  • QC Release Strategy (3-5 day release)
  • Good knowledge and application of MS-Office suite
  • Accuracy is your middle name
  • Provide subject matter expertise when launching a new project or service
  • Participate in product development, project reviews, and relevant project meetings
  • Review and approve design control documents and design changes
  • Support Deviations, Nonconformances, CAPA’s requiring Design Assurance input/approval
Senior Specialist Product QA
07/2006 - 12/2012
New York, NY
  • Support change control management as subject matter expert
  • Support the QA role in product investigation meetings as required
  • Represents Dako/Agilent to external bodies, dealing with standards and/or product regulations
  • Defining the quality parameters to the call agents and QA’s and defining the scope of improvisation
  • Kitchen production, lab environment experience or manufacturing facility
  • Math skills at a proficient level
  • Excellent keyboarding proficiency
  • Excellent computer skills particularly in the use of Outlook, Word, Microsoft Excel and PowerPoint


University of Massachusetts Amherst
2002 - 2006
Bachelor's Degree in Pharmaceutical Sciences

Professional Skills

  • Strong analytical skills with focus on finding the right solutions in compliance with the regulations
  • Be detail oriented, ability to be organized, and strong analytical skills
  • Quality assurance and/or health care experience including one year of claims adjudication experience
  • Presentation skills for training and audits and Senior Management
  • Experience: 6+ years experience in Quality Assurance, In Vitro Diagnostics (IVD), Medical Devices and/or Pharmaceuticals
  • Previous experience in supporting Quality Management Systems (QMTS) improvements
  • Experience preparing documentation for regulatory agencies

How to write QA Specialist / Senior Specialist Resume

QA Specialist / Senior Specialist role is responsible for auditing, training, integration, reporting, manufacturing, design, research, travel, compliance, automation.
To write great resume for qa specialist / senior specialist job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For QA Specialist / Senior Specialist Resume

The section contact information is important in your qa specialist / senior specialist 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
  • Email
  • Telephone number

Work Experience in Your QA Specialist / Senior Specialist Resume

The section work experience is an essential part of your qa specialist / senior specialist 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 qa specialist / senior specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qa specialist / senior specialist position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative QA Specialist / Senior Specialist resume experience can include:

  • Experience in the pharmaceutical industry including experience in bioanalysis and / or monitoring bioanalytical work, or equivalent experience as a GLP quality assurance auditor
  • Effectively identify, describe, and communicate issues in a timely manner and ensure issues are resolved to closure
  • Experience in GCP QA (3-4 years for Sr. GCP QA Specialist)
  • Participating in investigations relating to laboratories/ incoming material release/ systems and review/approve the investigation report
  • Understanding of batch making and compounding is necessary
  • Participating in quality training activities

Education on a QA Specialist / Senior Specialist Resume

Make sure to make education a priority on your qa specialist / senior specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa specialist / senior specialist 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 QA Specialist / Senior Specialist Resume

When listing skills on your qa specialist / senior specialist 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 qa specialist / senior specialist skills:

  • Experience with performing Quality Agreements and Supplier Audits
  • Knowledge of FDA and EMEA regulations, and process validation as well as a working knowledge of statistical analysis and root cause analysis is required
  • Good knowledge in the various regulatory requirements including Compendia requirements
  • Experience and practical knowledge about quality assurance for medical device products and components
  • Work Experience from other Medical Devices or IVD companies in a similar role
  • Experience with CAPA process is an advantage

List of Typical Skills For a QA Specialist / Senior Specialist Resume


Skills For QA Senior Specialist Resume

  • Industry experience in a pharmaceutical/biotech GMP environment
  • Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives
  • The difference in the value Assurant places on strong leadership
  • Monthly trending and reporting on CAPA process performance as well as preparing input to Management Reviews
  • Drive writing and maintaining Quality Agreements with Contract Manufacturers, Suppliers and Distributors
  • Utilizing data analysis and improvement tools
  • Six Sigma Greenbelt training would be helpful
  • Quality systems/ incoming material release knowledge

Skills For GCP / Senior GCP QA Specialist Resume

  • Review and approve preclinical and clinical documents, including GLP and GCP protocols and reports
  • Assess Quality Assurance of GLP studies including analytical and animal studies
  • Conduct GLP and GCP audits, monitor and track corrective and preventive actions resulting from audit findings
  • Lead GLP and GCP quality training
  • Have worked in a quality control laboratory is ideal
  • Knowledge of GMP’s and GLP’s required and knowledge of batch chemistry is necessary
  • This role does not offer relocation

Skills For QA Senior Associate / Senior Specialist Resume

  • Insurance, mortgage, or financial services
  • Knowledge of regulatory demands and standards: MDD, IVD, ISO 13485, MDSAP, FDA legislation
  • Lead Auditor in 13485:2016 is an advantage
  • Adherence to domestic and international GMP regulations, cGMP’s, company policies and DNA leadership capabilities
  • The people – we care
  • The diversity - every day is different
  • The excitement – we focus on ‘What Matters Most’ to our customers

Skills For Senior Specialist Product QA Resume

  • The opportunity to learn, grow and advance within our fortune 300 global company
  • Review project timelines to ensure accurate and timely integration of quality activities
  • Serve as GLP/GCP subject matter expert in support of internal and external preclinical and clinical study activities
  • Perform Quality Assurance audit of regulatory document preclinical and clinical sections
  • Lead as SME in the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DM/DPs revision, where gaps are identified, ensure that an implementation/mitigation plan is in place and follow-through to completion

Skills For ExO QA / IC Senior Specialist Resume

  • Reviewing/approving change controls and SOP for supporting areas
  • Support the compliance, audit, regulatory and training activities as required and any other responsibilities as assigned by Supervisor
  • Quality System(s) implementation and maintenance (if assigned)
  • Partner with Supplier organization to ensure continuous compliance to ISO 13485:2016 requirements and other relevant regulations and ensure efficient QA processes
  • Be part of Supplier audit team and perform Supplier Audits as lead auditor
  • Drive global QA SQM activities

Skills For Senior Global QA Chemisty Manufacturing & Controls Specialist Resume

  • Drive CAPA board with top management participation
  • Collaborate closely with Operations management to ensure timely and compliant product deliveries
  • Use a lean process view to constantly improve quality processes to become efficient, lean and in compliance with regulations
  • Participate in Supplier Management team meetings
  • Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system
  • Providing guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment

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