Working under the supervision of the quality engineer, the QA associate is involved in testing the new product to detect errors or mistakes and also finding ways to fix such defects. Some of the major roles and responsibilities that are taken care by these associates include – testing the product to ensure that it is perfect and useful, ensuring that the produced product has a blend of both usefulness and beauty, performing quality audits, drafting new strategies, keeping a track of all new products, and coordinating with advertising team to ensure that the product is advertised properly.
Some of the major skills candidates depict in their Quality Assurance Associate Resume are – testing abilities, ensuring both quality and cost check, strong communication skills, leadership skills, negotiation abilities, a good understanding of business processes and about the new product, and relevant computer competencies. The educational qualifications to be possessed for this role indicate an engineering degree with prior work experience.
Summary : Quality Professional with 12 years experience experience in organizing and managing services. On-the-spot decision making and supporting the employees. Focused on ensuring the guests' needs while enforcing standards for individual performance. Adept at general supervision, hiring, training and motivation of employees. Quality Professional with nine years in a regulated environment.
Skills : Management, Quality Assurance, Inventory Management, Customer Service, Money Handling, Excel, Office Applications, Analytics, Problem Resolution, Word, Windows.
Description :
Ensures and Follows established regulatory procedures from ARC directives, FDA regulations, state, and local laws.
Familiar with 21 CFR 210, 211, 606 and 610.
Retrieve, review, trend, analyze and report data using excel spreadsheets from Webi database.
Identifies and investigates problems and conducts root cause analysis.
Recommends corrective actions, dispositions and modifications.
Responsible for ensuring that all aspects, impacts, and causes of problems are identified, documented, and resolved, Ensures that all timeframes for problem reporting, corrective action plan development, implementation activities, and effectiveness checks are consistently met as outlined in the PM policy and procedures.
Maintains positive working relationships and manages cross-departmental activities through all stages of problem management.
Ensures that representatives from affected departments are involved in the identification, investigation, documentation, and corrective action planning and effectiveness checks for the appropriate problems.
Experience
10+ Years
Level
Senior
Education
Associates
Quality Assurance Associate Resume
Objective : Regulatory Affairs Professional and Analytical Scientist with more than 20 years combined experience in the pharmaceutical/ biotechnology and medical device industry. Solid scientific background with experienced management practices. Experienced in communication with FDA representatives through in-person meetings, written responses and telephone contact.
Skills : Good computer skills of MS Office.
Description :
As a Quality Assurance Associate, Reviewed batch records and analytical data against established standards.
Wrote, implemented and revised standard operating procedures (SOPs), Routed and released promotional materials to ensure compliance with regulatory submissions and requirements.
Maintained Quality Assurance promotional masters, product labeling masters, training files and product lot files.
Inspection of commercial products for release.
Ensured timely scheduled reviews of documents through appropriate individuals as required by state licensing agencies.
Created and formatted rework reports for the team supervisor to help facilitate employee reviews and provide team and department statistics.
Evaluated raw material evaluation for use in production.
Experience
2-5 Years
Level
Junior
Education
BS Biochemistry
Quality Assurance Associate Resume
Summary : Quality Assurance Associate is responsible for overseeing the quality assurance process of all products. This may include monitoring and reporting on product quality, ensuring that testing is performed in accordance with established guidelines, and providing metrics to track the effectiveness of the test process.
Skills : Microsoft Office, Excel.
Description :
Review and approve unexecuted batch records, packaging samples, and material specifications.
Assess label print batch records, batch record change controls and other documents.
Verification of materials necessary to complete a batch record.
Quality Control Associate, duties include daily inspections to ensure procedures are followed, provide feedback for any questions or comments from packaging associates, and perform audits on completed jobs.
Packaging Supervisor Proven leadership ability, including the ability to oversee and direct quality and regulatory activities.
Demonstrates pride in achieving highest possible standards and a work history featuring zero discrepancies.
Ability to identify and utilize the talents of team members effectively, enhanced by inspiration and motivation in order to reach goals and achieve desired results.
Excellent verbal and written communication skills, including a consistent ability to develop and maintain a positive team oriented environment.
Experience
10+ Years
Level
Senior
Education
Associates In Arts
Quality Assurance Associate Resume
Summary : As An Quality Assurance Associate, responsible for ensuring the quality of the product, which includes performing QA tests, managing a QA team, and providing project management support. The Quality Assurance Associate also works closely with the Product Manager to ensure that the product is delivered on time, within budget, and to high-quality standards.
Skills : MS Office, Electronic Health Records, Quality Assurance, Process Improvement, Program Management.
Description :
Responsible for regulatory compliance and quality of service delivery.
Decreased annual audit error rate to 1%, building the trust in the corporation with the Ohio Department of Mental Health and virtually eliminated significant fines.
Coached and trained clinicians to improve their skills and eliminate possible problem audit areas.
Eliminated paper audit and reporting process by maximizing technology resources.
This reduced staff time by 50% while exceeding Audit Department expectations.
Created policies and procedures to ensure compliance with HIPAA requirements.
Developed and presented staff training to offer in-house opportunity for professional growth.
Experience
10+ Years
Level
Senior
Education
BS
Production/Quality Assurance Associate Resume
Summary : Experienced Quality Assurance Tester. Utilize consulting skills on a daily basis to effectively communicate with others. Exceptional analytical and critical thinking skills with the ability to evaluate options Solid understanding of the point of contact with customers. Able to meet short deadlines while still delivering high quality results Proficient in Microsoft SharePoint.
Skills : Computer Repair, Knowledge of tools, People Person.
Description :
Filling/Formulations/Raw materials release) Responsibilities: batch record review, qualified for all areas of record review.
Performed deviation initiations, investigations, and closings.
Responsible for making "on the floor" quality decisions during filling and formulation processing.
Maintained batch data tables for trend analysis of deviations.
Revise SOP's to ensure adherence to cGMP and batch records.
Utilized "Trackwise" system for tracking and routing of all CAPA's throughout the plant.
Developed a new-hire/on the floor training program for QA associates to ensure cGMP compliance during processing.
Experience
10+ Years
Level
Senior
Education
QA
Quality Assurance Associate Resume
Objective : Certified quality control inspector; complete with lab training and experience. Provide reliability and consistency in the quality assurance of each product, within the completion of daily tasks. Proficient at conducting myself, in a matter that is conducive to company's policy and standards.
Skills : Rowan-Cabarrus Community College.
Description :
Utilizing laboratory testing equipment to test raw materials and finished product goods for chemical and microbiological aspects to ensure product meets quality specifications.
Calibrating lab equipment per calibration matrix and creating lab SOP's and training aids for new lab personnel.
Reporting any OOS data to QA Management and work with appropriate department to resolve issue while supervising/overseeing training of new QA lab personnel on laboratory practices and responsibilities.
Recognizing quality issues on production floor, troubleshooting or notifying maintenance and production supervisor of issue.
Audit production quality logs for accuracy, consistency, and to ensure product meets quality parameters set forth by QA.
Complete non-conforming raw material and corrective action/preventive action claims in a timely manner Monitoring and reporting wastewater pH utilizing AquaVX monitoring system and maintaining wastewater flow record, familiar with GMP's of a FDA regulated manufacturing facility.
Verification and calibration of WQMS probes on each production line.
Overseeing the resolution of non-conforming areas.
Experience
2-5 Years
Level
Junior
Education
BS
Quality Assurance Associate Resume
Summary : Experience in quality control, quality assurance, regulatory compliance and applied research within the life science environments of agriculture biotechnology and medical devices. Inspection and auditing of products, processes, facilities and documentation to evaluate quality, compliance or performance. Ability to plan and execute strategies and workplace solutions in office, field and laboratory environments, while providing exceptional support for the business and individuals.
Skills : QC, Production Management, Quality Certification, Regulatory Compliance
Description :
Supported the development and implementation of a Quality Management System and an Environmental, Safety and Health program to an organization of over 300 employees.
Established a standardized document control and communication platform.
Authored business and technical communications including quality and safety SOPs, training manuals, policies, forms, reports, and documentation to meet organizational needs.
Developed and managed a research internal auditing program.
Selected, trained and advised internal auditors.
Established auditing procedures and documentation.
Oversee audit findings, and advise corrective actions.
Conducted facility and field audits at multiple locations to verify all quality, regulatory and safety activities were performed in accordance with company policies, processes, operations and government regulations.
Experience
10+ Years
Level
Senior
Education
Certificate
Quality Assurance Associate Resume
Objective : Quality Assurance Professional with experience in Quality programs including reporting and capability at a regional level combined with my strong project management skills and being bilingual have extended my knowledge and expertise at a global level within the food & beverages industry, bottling manufacturing and R&D.
Skills : Clerical, Customer Service.
Description :
Manufactured initial components for oil rigs.
Responsible for utmost safety and quality of manufactured oil rig parts.
Inspected and tested parts to be discarded or rejected in meeting company conformance to specifications.
Assisted to identify and correct any issues, notified supervisors and other personnel of production errors.
Discussed inspection results with responsible employees to recommend necessary corrective actions.
Read dials or meters to verify equipment was functioning at specified levels.
Adjusted, cleaned and repaired products of processing equipment to correct defects found during inspections.
Experience
2-5 Years
Level
Junior
Education
Diploma
Quality Assurance Associate Resume
Headline : Conduct audits of source documents, protocols, ICH report to ensure compliance with SOPs, Regulatory guidelines and client protocol guidelines Collaboration with multidisciplines within organization to complete projects per timelines Maintain multiple projects simultaneously through planning, conduct, review and follow-up Initiated quality control incident reports and corrective action plans Proficient in MS Office.
Skills : Excel, Quality Assurance.
Description :
Conduct Social Science research in the public interest while maintaining confidentiality pursuant to Federal Laws.
Work closely with Production and Assistant Production Managers on new projects by providing ideas to improve member experiences.
Monitor Telephone Interviewers for quality, integrity and ensure proper and accurate data collection as well as a positive experience for clients and company.
Provide positive feedback and tools to interviewers to improve upon interviewing skills.
Provide over the phone web support to members who needs assistance navigating the companies' website.
Constant handling of confidential, sensitive, and protected information - per hipaa standards.
Final review of majority of incident reports throughout the organization.
Experience
5-7 Years
Level
Executive
Education
Certificate
Quality Assurance Associate Resume
Summary : Quality Assurance Professional with strong compliance experience. Extensive background in Consent Decree Remediation, Quality Assurance, Adverse Events/Complaints, Operations, and Packaging in the pharmaceutical and medical device industries. Demonstrated skills in problem solving and the ability to integrate the demands/responsibilities in Quality Assurance activities to ensure a compliant and team oriented work environment.
Skills : Windows, Microsoft Office, Microsoft Office, Adobe Acrobat.
Description :
Managed a broad range of responsibilities as a member of the Interventional Medical Products Quality Assurance team.
Worked on cross-functional teams to address product issues, define and implement effective corrective actions and monitor post-implementation effectiveness.
Worked with Product Surveillance associates in reviewing and approving product complaints.
Confirmed compliant and MDR reportability and completeness of the investigation within internal procedure(s) and external FDA/International standards and guidelines.
Involved in operational improvements, product development and design control activities, systems enhancement (including software implementation and validation), compliance auditing, vendor selection/approval, and associate training.
Reviewed and approved all manufacturing deviations.
Prepared and communicated quality reports.
Collaborated on a team to eliminate backlog complaints by reviewing and approving, 1000+ when started.
Experience
10+ Years
Level
Senior
Education
Diploma
Production/Quality Assurance Associate Resume
Objective : Organized and detail oriented professional with almost 3 years of Quality Assurance experience in a regulated GMP environment. Good communication and problem solving skills, adept at managing multiple projects. Authored multiple Standard Operating Procedures (SOP), Qualification Protocols and Methods. Acted as the de-facto supervisor of the QA team for 5 months. Supervisory responsibilities include, managing QA department and mentoring new QA staff.
Review batch production records, environmental monitoring and other manufacturing related documents.
Develop, revise and review SOPs, training materials and other documents as needed.
Perform SOP revision training, when necessary.
Release clinical products for patient use.
Review regulatory documents for accuracy, working with clinical trial sites and CRAs to resolve discrepancies.
Compile, organize and maintain database of data generated from phase I and II clinical trials.
Prepare quarterly manufacturing status reports.
Perform internal audits of documentations, databases and internal systems.
Experience
2-5 Years
Level
Junior
Education
Biotechnology
Quality Assurance Associate Resume
Objective : Quality Assurance professional with over 15 years of experience in all phases of pharmaceutical, clinical trial, in-vitro diagnostic kit and food production. Resourceful, results-driven and competent in diverse regulatory requirements. Proven record of initiating, designing and implementing numerous compliance programs. Experience supported by B.A. in Biology, ASQ Certified Quality Auditor (CQA) and computer literacy.
Skills : Microsoft Office, Excel, Quickbooks, Internet, Powerpoint, Adobe, Type 45 Wpm, Filing, Multi-Tasking, Customer Service, Photoshop, Phone Etiquette, Email, Scanning, Organizational Skills, Attention To Detail.
Description :
Developed comprehensive plant and equipment cleaning program in accordance with cGMP guidelines: Wrote and developed standard operating procedures and selected acceptable cleaning agents.
Established environmental monitoring program, contamination trending analysis and reporting system of excursions, ensuring compliance with aseptic manufacturing practices.
Produced several company training programs, videos, and documentation in compliance with federal regulations.
Researched and produced several process, system, and equipment validations resulting in safe, efficient and effective manufacturing.
Evaluated and reported recommendations to QA Manager for corporate acceptance/rejection.
Assisted to identify and correct any issues, notified supervisors and other personnel of production errors.
Discussed inspection results with responsible employees to recommend necessary corrective actions.
Experience
2-5 Years
Level
Junior
Education
B. A. In Biology
Quality Assurance Associate Resume
Summary : An accomplished QA professional with 18+ years' progressive experience with an emphasis in document control and quality assurance activities; adaptable to understanding and using a variety of database systems; skilled in maintaining aspects of controlling documents per 21CFR part 820 requirements.
Skills : Research, Organization, Communication.
Description :
Review and evaluate COs (Change Orders) to confirm documentation is complete and correct and changes are approved and implemented in accordance with company and regulatory guidelines.
Interact with and assist personnel from different levels and departments within the organization to prepare, administer, and control documentation.
Perform the input and electronic transfer of documentation related to COs in MasterControl and the Company's release drive and intranet.
Implement new part numbers and bill of materials in the ERP system, as well as editing existing ones.
Maintain records in accordance with Company procedures (including Device Master Records and Design History Records).
Responsible of documentation distribution and filing.
Assist in developing and implementing documentation systems.
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