QA Specialist / Senior Specialist Resume Sample
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
Education
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
- 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
1
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
2
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
3
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
4
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
5
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
6
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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