QA Associate Resume Sample
Perry Fritsch
91839 Grady Vista,
Boston,
MA
+1 (555) 415 5258
Work Experience
QA Associate
09/2016
-
PRESENT
Detroit, MI
- Proactively handling all quality compliance effectively
- Product quality reviews
- UK and/or EU experience
- GMP and GDP legislation
- Responsible for batch review and coordination of product release activities at Shire Contract Manufacturing Organizations (CMO) for both commercial Cinrzye, clinical Cinryze, associated by products and Legacy Baxalta products
- Responsible for the continuous operation of the facility’s mechanical systems, monitoring systems and equipment. Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. autoclaves, dishwashers, depyrogenation oven), as directed by QA Manager
- Knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA
- Work prioritization skills
- Keep comprehensive and accurate records in a multi-faceted environment
Senior QA Associate
03/2012
-
08/2016
Boston, MA
- Well-developed consultation and negotiation skills
- Write and route operating procedures, manufacturing documents, and other QA controlled documents in QUMAS
- Interact with internal customers
- Support quality systems
- Issue/review controlled forms
- Scan executed batch records and maintain electronic files for future reference as necessary
- File executed quality documentation in the records room
- Enter data into multiple systems to ensure compliance with regulations
Clinical Lab QA Associate
05/2007
-
11/2011
Houston, TX
- Perform walk-throughs, changeovers, and QA on the floor inspections
- Provide project support for QA
- Serve as customer proxy for projects as assigned
- Create and revise job aides
- Review and approve executed GMP batch documentation
- Generate, review, and apply product labels
- Serve as MRB coordinator
- Serve as QA resource for cleaning verification/validation
Education
International Technological University
2002 - 2006
Bachelor's Degree in Computer Science
Professional Skills
- Attention to detail, good organizational and interpersonal skills, and problem solving skills
- Positive interaction skills, attention to detail, and organizational skills
- Strong analytical skills. Ability to document business requirements and assist in developing reporting / data mining standards
- Excellent documentation and handwriting skills
- Excellent technical oral and written communication skills are required
- Detail oriented with excellent verbal communication skills
- Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
How to write QA Associate Resume
QA Associate role is responsible for organizational, reporting, database, technical, gmp, word, documentation, finance, training, integration.
To write great resume for qa associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QA Associate Resume
The section contact information is important in your qa associate 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 Associate Resume
The section work experience is an essential part of your qa associate 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 associate 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 associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QA Associate resume experience can include:
- Facilitating and coaching skills
- Communicating effectively, verbally and in writing, with all internal and external clients
- Quality experience, preferably including manufacturing operations, API and drug product release, QP release, process validation
- Demonstrated experience working with and preparing SOPs
- Prior experience working in a cGMP regulated environment, preferably in a pharmaceutical/biotech company
- Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations
Education on a QA Associate Resume
Make sure to make education a priority on your qa associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa associate 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 Associate Resume
When listing skills on your qa associate 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 associate skills:
- Good, clear communication skills with strong attention to detail
- Good time managements skills
- Possess good communication skills both written and verbally
- Strong Computer skills in spreadsheet and word processing applications is required
- Sound decision-making, technical and problem solving skills
- Expert technical writing and problem solving skills
List of Typical Experience For a QA Associate Resume
1
Experience For Senior QA Associate Resume
- Strong accuracy and attention to detail. Ability to multi-task, meeting tight deadlines in a fast paced environment
- Positive role model. Responds positively and energetically to changing circumstances and priorities and fosters collaborative relationships across groups
- Experience in auditing in a GMP environment
- Possesses a good understanding of current quality control GMP regulations
- Experience in pharmaceutical product development
- Provide validation / preventative maintenance support for critical equipment and write associated protocols
- Ensures that all documentation related to bulk and finished product release is collected and compiled prior to release
- Ensures that clients are forwarded scanned copies of necessary documentation prior to release of bulk and finished products or for approval of change controls
- Experience with SAP (an asset)
2
Experience For QA Associate / Batch Record Reviewer Resume
- Strong knowledge of GMP’s and their application
- Change management and CAPA management experience
- Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
- Promotes team work and good communication
- Experience in GMP regulated industry
- Previous QMS process design, implementation, management and utilization experience
3
Experience For Clinical Lab QA Associate Resume
- Represents QA in change control, standardization and consolidation activities to ensure implementation occurs in a state of compliance. (no adverse impact)
- Quality Assurance experience in an FDA or GMP regulated environment
- Five or more years of experience in the pharmaceutical quality function
- Experience in pharmaceutical product development and expectations for early phase clinical trials
- Checking the monitoring and control of the manufacturing environment. Support in checking and ensuring proper plant hygiene
- Ensuring continuity among corporate and divisional work teams by documenting and communicating actions, irregularities and continuing needs
4
Experience For QA Associate, Document Control Resume
- Leading GxP training sessions and hands-on training to support users in learning workflows for our electronic GxP data systems at deployment
- Ensuring the proper routing of documents for approval and training
- Providing training and guidance to staff regarding the use of the system
- Monitoring and reporting of quality activity ensuring management is informed in a timely manner of changes/trends that could affect SSPs quality system
- Participating in new hire interviews; facilitating hiring decision
- Producing and assessing/trending metrics from quality issues (audits, complaints, non-conformances etc)
- Checking and ensuring adequate control and monitoring of storage conditions for materials and products
- Working on special projects relating to the Quality Department’s Continuous Improvement Plan
- Managing the departments, roles, and training courses setup and maintenance
5
Experience For QA Associate Compliance Resume
- Approving and monitoring the performance of suppliers of materials
- Sampling of intermediate products within the manufacturing process
- Understanding and working knowledge of Quality Management Systems
- Manufacturing, Packaging, and Laboratories. Initiate and participate in investigations and CAPAs
- Reporting of SSPs audit performance and results to executive leadership corporate RAQA
- Working knowledge of GMP requirements and associated guidelines
- Manufacturing and quality control operations
- Maintaining external/internal audit observation database and track observation response
6
Experience For QA Associate / QA Specialist Resume
- Tracking to closure of corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformances and deviations
- Reviewing and approval of documentation associated with qualification exercise
- Performing QA review of source documents, case report forms (CRFs), offsite shipments and other reports for accuracy as needed
- Testing and inspection of product, as required by SOP and Finished Product Specification
- Working knowledge of US and EU Regulations and associated guidelines
- Training coordinator for QA group
- Training in QA, cGMP or an equivalent quality system
7
Experience For QA Associate, Data Reviewer Resume
- Working in A DevOps model
- Motivating financial remuneration and nonfinancial benefits
- Working knowledge of nutrition (i.e. Calories, Protein, Fiber, etc.)
- Working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer
- Liaise with customers to determine the impact on the Marketing Authorisation of any deviation raised during the manufacturing or testing processes
- Responsible for clean room changeover activities such as performing Environmental monitoring, checking room logs, equipment calibration and trash
- Provide training and coaching to manufacturing staff as needed
8
Experience For Marketing Optimization Control / QA Associate Resume
- Assists with the initial new employee training and maintaining employee training folders
- Become familiar with targeted list development for all ongoing Consumer Bank Marketing campaigns
- Review SAS and Unix code and modifications for ongoing marketing campaigns to verify accuracy and efficacy of changes
- Assist with development, testing, code review, and ongoing maintenance of automated campaign code
- Assist in investigations for deviations by supporting data gathering and root cause analysis
- Fundamental working knowledge of laboratory testing equipment and product transportation operations, pipeline locations and product specifications
9
Experience For Tax Conversion QA Associate Resume
- Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance’s, FDA regulations, etc
- Maintain logs of raw material usages and incoming/outgoing documents to/from QA
- Perform weekly and monthly metrics and trending reports for manufacturing
- Support product development teams for API/drug substance, drug product and/or labeling/packaging operations
- Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging, taking action to overcome likely obstacles
10
Experience For Contract QA Associate Resume
- Provide mentoring, assistance and training to core quality management system processes where required
- Ensure SSP maintains an exemplary record of compliance and commitment to relevant quality standards by working with, and influencing all departments
- Runs tests and retests as necessary, executing test scripts in area ofaccountability, reporting on test activities and results in accordance with project plans
- Assists in collecting and analyzing production samples to evaluate quality
- Maintain appropriate records of manufacturing/packaging for future reference
- Assist in troubleshooting course communications within our Learning Management System (LMS)
- Assist in conducting GMP training for the site for new employees
List of Typical Skills For a QA Associate Resume
1
Skills For Senior QA Associate Resume
- Demonstrated good judgment and decision-making experience
- Excellent knowledge of local and international Good Manufacturing Practices (GMP) and
- Exceptional attention to detail and competent with data entry/computer skills
- Approximately 3-5 years of experience in Food Safety Quality Assurance (FSQA) in industry; or exceptionally strong academic record or internship
- Demonstrated experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations
- Experience in a strongly regulated or GMP environment
- Liaison between QA and client to effectively communicate with clients with regards to executed batch records and review status
2
Skills For QA Associate / Batch Record Reviewer Resume
- Performs technical reviews and interprets data for accuracy of equipment/process performance for completed validations/revalidations
- Bachelors in Chemistry or Biology (or related field) with 4 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or,
- Masters in Chemistry or Biology (or related field) with 3 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or,
- PhD in Chemistry or Biology (or related field) with 2 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience
- Advanced computer skills, specifically in Microsoft Word, Excel, and Power Point
- Demonstrated experience in clinical safety laboratory management
- Organizational, leadership and project management skills
3
Skills For Clinical Lab QA Associate Resume
- Significant experience in a QA position and experience of working in a customer facing role is essential
- Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices
- Working directly with Bioclinica development teams to ensure the accuracy and consistency of system development and validation deliverables
- Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, Vendor management
- Experience in conducting and/or supporting customer/vendor audits
- Experience in implementing and maintaining quality systems
- Experience of working in clinical trials quality/packaging/distribution (IMPs, clinical trials)
4
Skills For QA Associate, Document Control Resume
- Experience in supporting manufacturing operations and batch record review is highly desirable
- Previous quality control or claims processing experience
- Advanced skill in technical writing
- Good programming knowledge in c, c++, Java
- Demonstrated ability to work independently while staying connected with key stakeholders
- Experience in change management and deviation resolution including CAPA systems
5
Skills For QA Associate Compliance Resume
- Review batch records, deviations, documents, and validation protocols ensuring GMP/FDA compliance
- Experience in Pharmaceuticals (Steriles or biotech manufacturing environment)
- Help provide quality oversight to production activities, including validation activities
- Experience in the development of training material & facilitation
- Strong attention to detail and accurate record keeping
6
Skills For QA Associate / QA Specialist Resume
- Review of manufacturing batch records, executed validation review, Maximo WO’s, and logbooks
- Possesses a good understanding of current quality assurance GMP regulations
- Experience working on large/medium sized projects ideally in Java EE with Payments Domain
- Sound working experience with
- Suggests and implements solutions balancing good science, product quality impact, GMP compliance, cost and business needs
7
Skills For QA Associate, Data Reviewer Resume
- Administrative experience, supporting multiple people
- Experience working in a QA department in GxP regulated facility
- Experience drafting SOPs and instructional materials
- Experience of TestComplete, Perforce, GIT LI-AK1
- Experienced with continuous improvement techniques
- Responsible for ensuring cleaning processes are validated to required standards
- Biotechnology, Pharmaceutical industry experience
- Contract Manufacturer Batch Record, validation documentation, general documentation, and deviation / investigation review and approval
8
Skills For Marketing Optimization Control / QA Associate Resume
- GMP experience
- Good motivator of personnel
- Good team player with a can-do attitude
- Provide validation/preventative maintenance support for critical equipment
- Technical Certification with 0-2 years of related experience
- Food industry experience, ideally in a Regulatory or Quality capacity
- Quality Control/Assurance GMP experience in a related field
9
Skills For Tax Conversion QA Associate Resume
- Experience with bath record review, approval and release, MFG line approvals, CAPAs
- Experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
- GMP or regulated environment experience is preferable
- Work experience with quality assurance systems and regulations
- Experience with co-ordination of internal and external audits
- Preferably, one to two years experience in a pharmaceutical QA/QC environment
- Very good knowledge in OOPS & SQL
- Relevant professional experience conducting QA audits in compliance with GCP and ICH
- Experience in pharmaceutical industry
10
Skills For Contract QA Associate Resume
- Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues
- Familiarization with oral solid dose manufacturing qualification and quality
- Experience in a Quality Assurance role in the pharmaceutical industry
- Experience with the qualification of facilities, utilities, equipment and processes
- Ideally 5+ years’ experience in the Medical Device Quality Systems
- Monitors performance of quality control systems to ensure effectiveness and efficiency
- 3D / 2D CAD software experience
- Manage product releases on a daily basis as requested in the priority list
List of Typical Responsibilities For a QA Associate Resume
1
Responsibilities For Senior QA Associate Resume
- Coordinates with CMO’s to obtain data required to generate the APQR’s. Reviews the data received and generates the final APQR for review and approval by QA management and Qualified person
- Initiation of deviation records in Shire’s Trackwise for major and critical deviations occurring at CMO’s or manufacturing plants for chosen product
- An exceptional communicator. To us, this means adaptable and personable writing skills, confident and articulate verbal skills, and active listening
- Proven customer service experience including phone interaction
- Work effectively in a small team environment
- Demonstrate sound decision making relating to quality issues
- Approve for release (or reject) packaged goods and manufactured products
- Quality Assurance QA experience within the food / pharmaceutical / dietary supplement industry
- Experience in a GMP environment required
2
Responsibilities For QA Associate / Batch Record Reviewer Resume
- Excellent attendance and ability to work overtime required
- Conducts on- and off- site audits, vendor qualifications and re-assessments, and computerized system validations (i.e. 21 CFR Part 11 compliance)
- Experience with GMP and/or other directives is an asset
- A good knowledge of GMP
- Review and approve final batch records prior to product release
- Review and approval of validation protocols and reports
- Food Safety Quality Assurance (FSQA) experience
- Liaising with manufacturing departments to manage timely review and completion of batch records
3
Responsibilities For Clinical Lab QA Associate Resume
- Maintaining the QA files/records for Customer audits
- Handling of Finished Product COA to customers
- Handling of Finished Product Releases via the Oracle System
- Administrate the activities for complaints processing (assessment, investigation, tracking, review, approval, escalation, trending)
- Ensure that all incoming materials and outgoing finished products comply with internal and FDA specifications
- Administrate the activities for Annual Product Quality Review (report writing, compilation, and tracking)
4
Responsibilities For QA Associate, Document Control Resume
- Responsible for routing and tracking documents with document control database
- Manage and audit proper use of the code version control tool used for marketing campaign support
- Manage multiple SFTP connections, for secure transfer of marketing files from Chase to approved Vendors
- Support site process improvements (training, efficiency projects, implementation of CAPAs)
- Provision of appropriate GMP/GDP training to appropriate job functions
- Natural aptitude for working with computer applications
- Assist in the development and maintenance of quality procedures and recording
5
Responsibilities For QA Associate Compliance Resume
- Function as QA auditor for in-process checks during production
- Route manufacturing and quality documentation to management for consensus and approval
- Manage physical inventory of documents control including documentation in the file room and electronic database of documentation
- Conduct daily and periodic audits and review Alaska Medicaid fiscal agent operations including but not limited to
- Responsible for review and approval of Manufacturing documents
- Responsible for maintaining timely and accurate ORACLE inventory transactions
6
Responsibilities For QA Associate / QA Specialist Resume
- Perform monthly material expiration reports throughout manufacturing
- Administrate and coordinate the activities for regulatory inspections including management of the regulatory responses
- Administrate the activities for the Vendor Assurance Program (tracking and contract renewal)
- Serve as subject matter experts on aforementioned activities providing technical guidance to team/local functions
- Lead auditor for internal (head office and branch), and external supplier audits including OEMs
7
Responsibilities For QA Associate, Data Reviewer Resume
- SME representing Quality for Merger & Acquisition activities
- Responsible for partnering with areas of business to ensure activities are in compliance with Quality System
- Provide mentoring and assistance to junior members of Quality team
- Knowledge and understanding of applicable external regulatory standards
- Assists in communicating quality control information to all relevant organizational departments, outside vendors, or contractors
8
Responsibilities For Marketing Optimization Control / QA Associate Resume
- Assists in communicating quality control and analytical procedures to staff
- Assists in analyzing quality control test results and provides feedback and interpretations to production management or staff
- Produces reports regarding non-conformance of products or processes, daily production quality, root cause analyses, or quality trends
- Identifies and reports deviations from established standards in the manufacturing process
- Proficient with Sam’s Club systems, policies, and procedures that are related to servicing members
- Very familiar with FSMA (Food Safety Modernization Act), HAACP, SQF, and other FDA regulations pertaining to food industry
- Monitor project status with regular reporting of supplies metrics
- Review and approve technical reports and protocols originating in other departments
- Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements
9
Responsibilities For Tax Conversion QA Associate Resume
- Provide on the floor QA support and perform QA Operations activities (batch record review, documentation review, product sampling, oversight, etc.)
- Prepares temperature sensitive filled product for shipment to commercial partners as well as contract manufacturers per SOP’s
- Support team as needed for the controls and quality standards for transportation and temperature control management activities
- Support team as needed for the quality oversight of all product quality holds and field actions related to transportation within EMEA
- Implement quality program for evaluating and monitoring the company’s quality and transportation process capabilities against company and industry standards and regulatory expectations
- Medical device, Pharmaceutical DC or Transport Q&C management
10
Responsibilities For Contract QA Associate Resume
- Recommend ongoing process improvements to the campaign list management team, especially as they pertain to improved efficiency and reduced opportunity for error
- Responsible for the execution of Quality Management System and Compliance elements such as documentation, record, metrics and KPIs, dashboard, training, audit schedule and follow-up
- Works crossfunctionally to assess impact for potential deviations and assist in identifying if an investigation is required
- Other assignments as needed within the scope of QA Associate training curriculum
- Responsible for the quality oversight of all product quality
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
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