QA Officer Resume Samples

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A Kuhlman

Audra

Kuhlman

831 O'Keefe Ferry

San Francisco

+1 (555) 404 7792

831 O'Keefe Ferry

San Francisco

Phone

p +1 (555) 404 7792

Experience Experience

Los Angeles, CA

QA Officer

Los Angeles, CA

Leffler, Harber and Connelly

Los Angeles, CA

QA Officer

Support Compliance manager by conducting periodic QMS management review and following actions
Assist with the provision and analysis of quality systems metrics for Management review
Assist with the internal quality system audit program and corrective action plan development and implementation
Work with operations managers to ensure costs are within the budget in driving quality initiatives
Identify and implement process improvement opportunities, convey to management and track benefits
Identify key stakeholders, build, develop and manage the relationships
Manage the Change Control System

Phoenix, AZ

QA Officer KYC Recertification Preparation

Phoenix, AZ

Quigley Inc

Phoenix, AZ

QA Officer KYC Recertification Preparation

Ensure that upon approval, ISPL Processing team has forwarded KYC Recertification Information to Static Data Team for maintenance
Conduct SLA scoping control to ensure that ISPL KYC Recertification Preparation team has not worked on files which are not in the ISPL scope based on the SLAs signed with different regions
Conduct root cause analysis of refer-backs received from Onshore team by ISPL KYC Recertification Preparation Team and identify action plan to ensure that the refer-backs do not recur. Monitor the implementation of action plans
Ensure that the ISPL processing team has directed SBO contacts to collect missing documents, opinions and sign off
Extraction of the list of completed cases for sampling
Perform Quality Assurance (QA) on sample approved KYC Recertification Preparation cases for all the regions supported by ISPL team and verify adherence to CIB KYC Procedure and existing ISPL procedures
Ensure that all hits found during background checks are addressed as per KYC policies

present

Houston, TX

QA Officer Kyc-associate / Senior Associate

Houston, TX

Heidenreich-Koelpin

present

Houston, TX

QA Officer Kyc-associate / Senior Associate

present

Ascertain if the ISPL processing team has identified all beneficial owners (including shareholders, directors, key managers etc.)
Ensure that all the necessary checks (3rd parties, website, stock exchange) to complete the recertification preparation task of the KYC have been performed
4 Strong knowledge of the global and local regulations regarding company structures, AML and financial markets
Conduct SLA scoping control to ensure that ISPL KYC Preparation team has not worked on files which are not in the ISPL scope based on the SLAs signed with different regions
Perform Quality Assurance (QA) on sample approved KYC cases for all the regions supported by ISPL team and verify adherence to CIB KYC Procedure and existing ISPL procedures
3 Strong knowledge of the on-boarding/ KYC process for Corporate and Institutional Banking
Ensure that the ISPL processing team has got KYC forms and other mandatory documents validated by Business Line / Coverage in charge

Education Education

Bachelor’s Degree in Scientific Field

Ball State University

Bachelor’s Degree in Scientific Field

Skills Skills

Understanding of Quality Management Systems and preparation of quality documentation
Strong team worker but capable of working effectively on an individual basis
Ability to analyse problems to assist/support stakeholders and customers
Proactive and solution driven with the ability to work to deadlines with a high level of accuracy
Knowledge of Onboarding and maintenance processes
Internal auditing experience to ISO 9001:2000 would be desirable
Ability to analyse data for contribution to change agenda decision making
Excellent communication skills both verbal and written
Knowledge of ISO 13485 and FDA cGMP
Excellent organization skills

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15 QA Officer resume templates

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Sanctions QA Officer Resume Examples & Samples

Undergraduate degree required and graduate degree, Masters and/or Law Degree, highly desirable
A minimum of 0-2 years experience in sanctions compliance, quality assurance, and/or forensic services
Project management experience desirable, but not required
Understanding of sanction regulations, transaction screening, and/or payment/banking products desirable

QA Officer Resume Examples & Samples

SOP document generation and review
Non-conformance review and follow-up of Corrective Actions
Preparation of the Internal Audits Schedule and ensure completion of the internal audits
Preparation of External Audit Schedule and ensure all actions are closed following completion of the audit
External auditing of the component suppliers and contractors when required (with the QP)
Co-ordination and final approval of customer complaint/recall handling (in conjunction with Quality Manager and QP)
Ensure Quality Manager/QP are appraised on all Quality related issues
Liaise with the Quality Manager/Qualified Person, as necessary, on technical issues including deviations, CAPA. Where relevant the expertise of the regulatory colleagues who are the MAH shall be obtained
Liaise with the MAH in relation to Marketing Authorisation variation updates/PIMA Licence updates as required and to ensure that the product has been repacked as per the agreed specifications
Vendor evaluation through questionnaire as required
Liaise with customers for component queries in relation to Quality as required
Generation of QA Despatch documents (including Batch Release Certificate)
Attend Health & Safety meetings
Contribute to Company Training procedures as required
Ensure safe work practices are being followed at all times, and report any defects immediately to the Safety Office
Ensure excellence in Housekeeping
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company
5 years' experience in a similar role

QA Officer Resume Examples & Samples

Build and improve a mature Quality system for MD/IVD trading to control Quality alignment and execution with China quality related regulations (GSP), ISO 13485, CTC Quality Manual and Corporate Procedures
Support Compliance manager to implement GSP for MD/IVD trading control in the company
Support Compliance manager by conducting periodic QMS management review and following actions
Lead and organize audit program for MD/IVD in CTC both internally and externally, as well as audit of vendors and dealers
Builds an influential and effective Network and communication with Supply Chain and other key functions as appropriate, in order to escalate and resolve issues
Support on ISO 13485 certifying to CTC MD/IVD trading. (2017)
5+ years’ experience in the Medical Device industry or associated manufacturing or service industries
Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to China GSP, 21 CFR 820, and ISO 13485
Thorough understanding of quality science, knowledge of continuous improvement methodologies, knowledge of quality systems
Excellent track record of cross functional engagement
Problem identification, analysis, providing solutions
Fluency in English both on speaking and writing to fulfill daily communication with global team
QMS experience in MD/IVD trading company or CFDA licensed 3PL
ISO 13485 internal auditor

QA Officer Resume Examples & Samples

# Develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review
Educated to degree level (Life Sciences or Chemistry) with 3+ years industry experience
Working knowledge of US FDA, 21 CFR part 210 and 211 and EU GMP requirements
Knowledge of US FDA 21 CFR part 4 (cGMP Requirements for Combination Products) and ISO 13485
Experience in designing and implementing quality systems and/or a start-up desirable
Experience in or knowledge of inhalation dosage forms an advantage
High proficiency in Microsoft Word/Excel/Powerpoint/MS Project etc
Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc
Good team working and strong communication skills across functions and organization
An ability to work flexibly in a changing environment. Good attention to detail and priority management essential
Flexibility to learn new skills and take on new tasks and responsibilities
The ability to work under pressure to demanding schedules is important, as is the ability to work on one’s own initiative

QA Officer Resume Examples & Samples

Work with production management to drive improvements in cGMP compliance across all shifts
Review all batch documentation, liaising with production management to resolve and clarify any points of issue
Provide an “on-line” Quality presence in the production area during manufacture with particular regard to on-line document and product checks and quality support for production enquiries
Inform line management of any issues relating to the quality of product or materials
Provide functional support and input into Tripartite meetings, thus ensuring timely critical thinking and decision making when production events are encountered
Ensure that appropriate problem solving methodology is used as part of investigations to find true root cause and resolve business issues
Follow up production events by recommending appropriate courses of action, if necessary by liaison with senior production, development and Quality staff, ensuring that all actions are completed
Conduct self-inspection audits of the production area and specific site systems in accordance with the agreed schedule
Life Sciences Degree or equivalent preferred
Prior experience gained in a Pharmaceutical manufacturing/ Quality Control environment
Self starter with strong “Can do” attitude
Excellent level of numeracy and attention to detail

QA Officer / QP Resume Examples & Samples

Collaborate with manufacturing and engineering functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality
Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality
Conduct checks and reviews of manufacturing operations to monitor factors which may affect product quality
Review and evaluate all internal executed batch records to facilitate disposition of product for Batch release
Review externally manufactured product documentation
Participate in site commissioning and qualification program
Review and participate in all deviations and changes to manufacturing operations to ensure appropriate investigation and assessment carried out and actions implemented and monitored
Ensure continued product quality through the Quality System by
Maintaining oversight of on-site operations
Participating in the preparation and review of Product Quality Reviews
Participate in self inspections
Use of Quality Risk Management to ensure manufacturing operations are adequate
Educated to degree level with 5+ years industry experience and completion of the educational requirements to act as a Qualified Person, a distinct advantage
Working knowledge of EU & US regulatory requirements
Experience with Investigational Medicinal Products manufacturing, an advantage

QA Officer Kyc-associate / Senior Associate Resume Examples & Samples

Perform Quality Assurance (QA) on sample approved KYC cases for all the regions supported by ISPL team and verify adherence to CIB KYC Procedure and existing ISPL procedures
Communicate deviations, if any to ISPL KYC Preparation team, Onshore processing team, Onshore QA team and identify action plan in conjunction with stakeholders and monitor the completion of action plan
Conduct SLA scoping control to ensure that ISPL KYC Preparation team has not worked on files which are not in the ISPL scope based on the SLAs signed with different regions
The QA Officer needs to independently perform QA on KYC Preparation process for sample cases. Key steps for control of controls include
Extraction of the list of completed cases for sampling
Determine the representative samples for QA
Ascertain if the ISPL processing team has obtained latest mandatory documents and reports as per requirements
Ensure that the ISPL processing team has directed SBO contacts to collect missing documents, opinions and sign off
Ensure that the ISPL processing team has got KYC forms and other mandatory documents validated by Business Line / Coverage in charge
Ascertain if the ISPL processing team has identified all beneficial owners (including shareholders, directors, key managers etc.)
Ascertain if the necessary background checks (including checks against local and global blacklists) are conducted on all beneficial owners
Ensure that all hits found during background checks are addressed as per KYC policies
Ensure that all the necessary checks (3rd parties, website, stock exchange) to complete the recertification preparation task of the KYC have been performed
Ensure client files pass all quality and control reviews
3 Strong knowledge of the on-boarding/ KYC process for Corporate and Institutional Banking

QA Officer Resume Examples & Samples

Verification of documents and process activities including caliberation as per SOP during manufacturing
Ensuring that approved RM, PM, Process activities, SFG, FG., are released
Training of workmen as per FSMS requirements and with documentation
Quality and product reviews with required action plan for Non-conformances, deviations , find out RCA and closure of NCs with CAPA
Pre dispatch inspection and release of product to ensure that product meets desired specifications,
Adherence to all food safety and safety requirements as per Company requirements and specifications and assuring its implementation
Ready to work in Shifts

QA Officer Resume Examples & Samples

System owner for site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review
Provide QA support to site commercial readiness activities by maintaining the site Inspection Readiness program
Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and corporate Quality
Support operation of the site Training system, including preparing and presenting relevant training material, as required
Keep abreast of regulatory initiatives and new guidance/requirements
Support the implementation of the Operational Excellence program by identifying, leading and implementing improvements
Comply with company and Legislative Environment, Health and Safety Requirements

QA Officer Resume Examples & Samples

Adequate knowledge and understanding on the Quality Assurance activities
Adequate knowledge on Master formulae records, Complaint handling, deviation handling, change control handling, Validations
Prior experience in Quality Assurance department of Pharmaceutical Industry is preferred
B. Pharm with 2+ years’ experience in relevant field

Overt QA Officer Resume Examples & Samples

Maintains compliance by performing overt performance audits, which includes checking for the appropriate document security, assuring that required record keeping practices are being followed, verifying licenses or certificates and other required display information, observing and performing a written evaluation of each inspector’s ability to properly perform an inspection; appointing and canceling stations from the program; serving suspensions on stations/technicians; responding to consumer complaints concerning stations/technicians; testifying in administrative and Court of Common Pleas hearings; represent the Department of Transportation at safety/I/M inspection meetings
Contributes to program efficiency by participating in public speaking events, providing manager with innovative ideas and ways of triggering audits to maximize integrity; by educating station personnel on program procedures and practices
Contributes to management’s knowledge of the program by providing general feedback as to the testing industries positive and negative actions, concerns, etc
Contributes to team effort by accomplishing assigned and ad hoc tasks, as needed

GMP QA Officer Resume Examples & Samples

Significant experience in Pharma GMP environment
Experience as GMP Auditor
Awareness of quality systems/standards, e.g. ICHQ10
Good Communication/ Negotiation/Decision Making/Problem Solving Skills
Customer Service Orientated/Ability to Interact Effectively with Clients
Experience in process improvement

QA Officer Resume Examples & Samples

Performs daily reviews on completed customer registration requests to ensure 100% accuracy on the actions taken by the processing team
Handles complex onboarding tasks, including complex requests, validations, escalations and enquiries, among others
Develops process expertise within the team and serve as point of contact for process related queries
Acts as trainer and SME for new and existing hires
Identifies process improvement opportunities
Conducts quality coaching to staff as needed and delivers bi monthly accuracy team reports
Control focused; Ensure that all necessary controls are implemented in the process; think of new controls that will reduce and/or eliminate process and operational risks
Acts as first point of contact for any issues relating to quality and partners with internal Assurance teams
Responsible for coordinating with onshore counterparts to ensure that process documentation and WI are updated

Cbps AU QA Officer Resume Examples & Samples

Attention and thoroughness to details, coupled with a strong follow through discipline
Strong Controls and Compliance orientation
Ability to liaise and interface with all levels within the organization and across all functions
Has not been under PIP in the last 6 months; no any compliance, discipline or performance issues
Must be flexible as he/she may be assigned in any of the operation units within CBPS
Attentive to detail and possesses high analytical skills

QA Officer Resume Examples & Samples

Life sciences graduate
At least five years’ experience working in a Quality Assurance role
Strong working knowledge of GDP and GMP
Preferably administrative work experience in a business setting
Computer literacy (Microsoft Office Package)
Good organisational skills and attention for details
Excellent prioritisation skills
Ability to work well with others in fast paced, dynamic and multi culture environment

QA Officer Biologics Resume Examples & Samples

Actively support the development and implementation of the Quality Management System at Mylan Dublin Biologics Quality
Develop and maintain local Quality Systems, including SOPs, change control, investigations, CAPA, internal auditing, Vendor qualification & management, GxP documentation management, batch disposition, complaints and annual product review for commercial and/or clinical operations as appropriate
Author and review SOPs and Technical Agreements in accordance with procedure, and review Third party GxP documentation in support of Quality Systems and batch disposition
Support operation of the Training system, including preparing and presenting relevant training material, as required, and manage the GMP Training program and deliver GMP Induction & Refresher training
Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality
Maintain the Manufacturing License and revise when required, and manage Third Party KPIs
Support the implementation of the Mylan Operational Excellence programme through improvement initiatives
Provide QA oversight of contracted Clinical Research Organisation’s including, Product Specification File generation and maintenance, review of clinical label packs, and support and execute any other duties as assigned
3rd level qualification in science related discipline
Minimum 3 years’ experience within the pharmaceutical industry
Relevant experience in GMP/GLP environment – Biologics, Clinical and/or Medical Devices an advantage
Background in Regulatory Affairs an advantage
Proven track record as a team player
High level of proficiency in Microsoft Word/Excel

Overt QA Officer Resume Examples & Samples

Responsible to self-manage a set amount of station visits and audits for an assigned area
Maintains compliance by performing overt performance audits, which includes checking for the appropriate document security, assuring that required record keeping practices are being followed, verifying licenses or certificates and other required display information, observing and performing a written evaluation of each inspector’s ability to properly perform an inspection
Appointing and canceling stations from the program; serving suspensions on stations/technicians; responding to consumer complaints concerning stations/technicians; testifying in administrative and Court of Common Pleas hearings; represent the Department of Transportation at safety/emission inspection meetings
Maintains program compliance by performing equipment audits
Conduct customer complaint resolution reports and vehicle re-inspections at inspection stations. The QAO position will substantiate their findings via a paper report that will be submitted to the Department of Transportation for possible further action
Act as Referee inspector, when necessary
Must be able to successfully complete and maintain a safety inspection mechanic certification and certified emission inspector certification
Must possess a valid, clean PA drivers license
Driving company vehicles for repair, transfer, acquisition, road testing, etc... includes continuous drive times up 90 minutes
Walking in and around vehicle inspection station repair and office areas, including up and down steps when necessary
Frequent sitting/standing - accessing into and out of vehicles
Lifting, pushing, moving and/or carrying objects up to 50 pounds (e.g vehicle parts, audit gas bottles, shop tools, tires/wheels)
Sitting and writing reports, typing reports into laptop computer
Exposure to weather conditions - hot and cold temperatures. Exposed to vehicle repair shop environments

QA Officer Biologics Resume Examples & Samples

Develop and maintain local Quality Systems, including standard operating procedures, change control, investigations, corrective and preventative actions, internal auditing, vendor qualification & management, GxP documentation management, batch disposition, complaints and annual product review for commercial and/or clinical operations as appropriate
Maintain the Manufacturing License and revise when required, and manage Third Party key performance indicators
Support the implementation of the Mylan Operational Excellence program through improvement initiatives
Provide QA oversight of contracted Clinical Research Organisations including, Product Specification File generation and maintenance, review of clinical label packs, and support and execute any other duties as assigned
Minimum 3 years’ experience within a Pharmaceutical QA role
Relevant experience in GMP/GCP environment - Biologics, Sterile, Clinical and/or Combination Products an advantage

QA Officer Resume Examples & Samples

Manage the company’s Calibration Program
Manage the Quality Incident & Deviation System
Manage the Change Control System
Investigate and report on any Customer Complaints
Manage the company’s CAPA Database
Generate Certificate of Analysis (CoA’s)
Assist in internal and external GMP and quality audits
Tertiary degree in Scientific Field
Experience in a similar role
Knowledge of the application QC/QA practices, procedures 7 QMS
Knowledge of workplace health & safety and safety practices relevant to chemical laboratory environment
Application of measurement and calibration techniques

QA Officer KYC Recertification Preparation Resume Examples & Samples

Perform Quality Assurance (QA) on sample approved KYC Recertification Preparation cases for all the regions supported by ISPL team and verify adherence to CIB KYC Procedure and existing ISPL procedures
Communicate deviations, if any to ISPL KYC Recertification Preparation team, Onshore processing team, Onshore QA team and identify action plan in conjunction with stakeholders and monitor the completion of action plan
Report deviations, if any, to all stakeholders along with the action plan and status of completion as a part of governance structure
Conduct SLA scoping control to ensure that ISPL KYC Recertification Preparation team has not worked on files which are not in the ISPL scope based on the SLAs signed with different regions
Conduct root cause analysis of refer-backs received from Onshore team by ISPL KYC Recertification Preparation Team and identify action plan to ensure that the refer-backs do not recur. Monitor the implementation of action plans
Ensure data and documents are uploaded (scanned and archived) into systems properly
Ensure that upon approval, ISPL Processing team has forwarded KYC Recertification Information to Static Data Team for maintenance
Escalate concerns / issues as needed to stakeholders
Communicate within the OPC team, Compliance, the business and IT and other stakeholders
Contribute to the implementation of Permanent Control policies and procedures
Actively participate in regular review of operational procedural changes /requirements from control perspective
Actively participate in Projects / System Changes from the controls and risk perspective when required
4 Strong knowledge of the global and local regulations regarding company structures, AML and financial markets

QA Officer Resume Examples & Samples

Maintenance of the Quality System to ISO 9001, 13485, FDA and CMDR standards. Ensure compliance with GMP and GDP requirements
Assist with the key quality processes (e.g. controlled document management, change management, CAPA, internal quality audit, training and supplier/vendor quality assurance)
Assist with the internal quality system audit program and corrective action plan development and implementation
Assist with the provision and analysis of quality systems metrics for Management review
Updating and creating new quality documents according to procedure
Build internal relationships: improve knowledge of business and relative departments ensuring that quality is a high priority
Completion of batch documentation review and release
Upkeep and maintenance of Technical Files
Understanding of Quality Management Systems and preparation of quality documentation
Internal auditing experience to ISO 9001:2000 would be desirable
A working understand of the IVD Directive and CE Marking requirements
Experience in preparation of technical documents and written reports
Background in Medical Device or IVD industry
Knowledge of ISO 13485 and FDA cGMP

GLP / GCP QA Officer Resume Examples & Samples

Performs protocol, data, report, and in-lab phase inspections for a specific study type in support for both large and small molecule to verify conformance to applicable SOP and regulatory requirements
Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records)
Notifies management of service failures
Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload
Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization
Performs SOP reviews
Starts to participate in internal facility and supplemental inspections, under supervision
Starts to deliver basic quality/regulatory training, under supervision
Identifies opportunities for process improvement and harmonization efforts that promote best practices
At least 1 year of experience as a quality auditor in a GxP-regulated environment