QA Officer Resume Sample
Sydney Bechtelar
30611 Shemar Landing,
Boston,
MA
+1 (555) 893 3009
Work Experience
QA Officer Kyc-associate / Senior Associate
04/2018
-
PRESENT
Phoenix, AZ
- The ability to work under pressure to demanding schedules is important, as is the ability to work on one’s own initiative
- Strong understanding of the cCMP’s with 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 desirable
- The role requires Good team working skills along with the ability to act on your own initiative and strong communication skills are essential
- Present opportunities for improvement and continually strive to create an operationally robust Quality System while at all times maintaining and exceeding the regulatory expectations
- . Good attention to detail and priority management essential
- Experience in the Medical Device industry or associated manufacturing or service industries
- Experience in Banking / financial services Industry with Min. 1 year in due diligence onboarding / recertification, AML, Compliance related activity or relevant experience
QA Officer
07/2011
-
10/2017
Boston, MA
- Review/revise/distribute controlled documents (e.g., forms, spreadsheets, procedures, work instructions, etc.)
- Monitor/review MDL studies, LOD/LOQ verifications and other QC studies
- Assist with PE (proficiency evaluation) studies
- Assist with audits (both internal and external)
- Conduct internal audits and test method assessments
- Assist with applications for certification/accreditation
- Conduct root cause analysis and document corrective action investigations
- Implement, monitor and verify closure of corrective actions
- Review RFPs (requests for proposal) and assist with clients’ QAPP (quality assurance project plan) preparations
Overt QA Officer
09/2005
-
02/2011
Phoenix, AZ
- Assist with training (including quality system, manual integration, and technical training) and maintain training database
- Proactive approach to problem solving and continuous improvement
- Responsible for analysis of validation samples, stability samples, Water Analysis
- Handling and maintaining RM, FG Control samples
- Perform validation activities
- Updation and maintenance of laboratory documents and records
- Conducting RM, PM,SFG& FG analysis as per test protocols
- Adequate knowledge and understanding on the Quality Control activities
Education
Indiana Wesleyan University - Cincinnati Education Center
2001 - 2005
Engineer's Degree in Management
Professional Skills
- Technical knowledge in the application of engineering, environmental, procurement, construction, testing, or operations or decommissioning practices sufficient to comprehend specified engineering, environmental, procurement, construction, testing, operations, decommissioning, and regulatory requirements
- Strong organizational and reasoning skills required
- Have a strong knowledge of Microsoft software systems coupled with good communication skills
- Demonstrated understanding and practicle experience of continuous improvement activities related to a manufacturing environment
- Significant experience working within equipment/facility revalidation preferably “steriles”
- Experience as a quality auditor in a GxP-regulated environment or similar working experience in a GxP-regulated environment
- Prior experience with regulatory bodies such as FDA and MHRA is highly desirable
How to write QA Officer Resume
QA Officer role is responsible for finance, events, training, integration, database, planning, reporting, manufacturing, design, research.
To write great resume for qa officer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QA Officer Resume
The section contact information is important in your qa officer 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 Officer Resume
The section work experience is an essential part of your qa officer 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 officer 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 officer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QA Officer resume experience can include:
- Good communication skills and interpersonal savvy
- Communicate effectively with other employees and participate with them in planning and problem solving activities, as required
- Prior experience with Cephalosporin’s would also be an advantage
- Experience within the Pharma industry (or other regulated industry) essential, with preferably Quality Assurance or production experience
- Providing Quality Input on the life cycle of Validation documents from URS’s through to PQ’s
- Drive quality initiatives across the business to enhance customer experience
Education on a QA Officer Resume
Make sure to make education a priority on your qa officer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa officer 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 Officer Resume
When listing skills on your qa officer 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 officer skills:
- Practical work experience in engineering, environmental science, procurement, construction, testing, operations, decommissioning, or business administration
- Provide direction and establish goals for individual staff members and work groups (planning/prioritizing/goal setting)
- Experience of working in a sterile manufacturing facility would be advantageous
- Skill in evaluating operations according to company and regulatory guidelines (policies, processes, procedures)
- Experience in a Pharmaceutical/Food Packaging environment or relevant manufacturing and production environment preferable
- Previous experience in working with suppliers
List of Typical Experience For a QA Officer Resume
1
Experience For QA Officer Biologics Resume
- Providing quality and compliance input in reviewing of Batch Manufacturing Record Reviews, CAPA’s & Deviations, Complaints & OOS across departments
- Implementing QA on the shop floor; reviewing sterilization cycles, FMS systems and cleanroom logbooks
- Working closely with the site Qualified Persons (QPs) ensuring batch release schedules are adhered to
- Training/coaching of Operations staff & QA peers
- Training management and business owner of the training database
- Providing annual product reviews for our client’s product
- Media fill observation, reading & report writing
2
Experience For Overt QA Officer Resume
- Media fill observation, incubation, reading & report writing
- Adequate knowledge on documentation, Handling of Analytical instruments
- Review and update of Standard Operating Procedures and Controlled Documents as required
- Participation in investigating customer complaints
- Cleanroom opening support (requalification of equipment & services)
- Collation and review of manufacturing and QC test data. Batch release
3
Experience For QA Officer KYC Recertification Preparation Resume
- Lead and manage assigned Quality systems and processes, ensuring compliance, efficiency and improvements are driven, maintained and developed
- Supervision of packaging areas; comportment & compliance to SOPs
- Clean room full physical – velocities, air patterns, DOP tests & particle counting
- Write local QA standard Operating procedures
- Give QA training to all Sandoz employees
- Premarket QA / Design Assurance / R&D Quality
- To carry out the assessment of all batch related data to ensure that all the required steps for documentation review are carried out in a timely manner to meet customer service requirements
4
Experience For GLP / GCP QA Officer Resume
- To monitor the adherence to cGMP by the execution of regular local audits within the production facilities. Identify any shortfalls and participate in their resolution to promote a culture of right first time
- To be conversant with site systems, ensuring compliance and to promote and monitor adherence to these systems by providing coaching, explanation and support within the production areas
- Working closely with Production and Engineering to ensure new products are manufactured in accordance with cGMP
- To monitor operational data to ensure that any adverse processing trends are identified and reported
- Closure of batch records with associate LIMS & SAP transactions & C of A generation
- Local area & local system audits
- Assist with the management of non-conformances, change controls and documentation
- Conduct internal and supplier audits
5
Experience For GMP QA Officer Resume
- Deputy to Senior QA Officer
- Evaluation of legacy non lot controlled items based on the new system design, to ensure materials are correctly categorised with appropriate specifications and documentation
- Provide effective re-validation resources to the aligned cell
- To identify, design and deliver cGMP training to support improved application of cGMP standards
- To carry out audits to support the identification, actioning and close out of non-compliance issues
- Support to Supplier Quality Managers in coordination of supplier evaluations and audits
- To review and approve batch manufacturing and packaging documentation within agreed timelines to support product release typically spending 50% of time on the line performing batch reviews and line audits
- To review and approve quality documentation to ensure compliance with cGMP
6
Experience For Cbps AU QA Officer Resume
- To prepare and complete product quality reviews to ensure compliance with regulatory requirements
- To close out failure investigations and preventative actions to reduce repeat failures and to monitor actions to meet target completion dates - Non Conformance Investigations/Reports
- Understand, and accurately follow internal Quality procedures (local and global) & GMP in accordance with EU guidelines and legislation
- Support the Eastbourne batch release process, through the preparation and provision of necessary documents, documentation review and approvals
- Support the provision of GxP & Quality advice and education to Eastbourne Operations and other functional teams including Senior Management, Supply Chain, Engineering, Origination and Finance
- Provide QA oversight to operational activities taking place within the aligned cell
- Review of sterilization cycles, FMS systems and other key controls of clean rooms
- Review of logbooks & support area controls
7
Experience For QA Officer Kyc-associate / Senior Associate Resume
- Online review of batch records
- Closure of batch records with associates LIMS & SAP transactions & C of A generation
- Proactive generation and timely investigation/review of minor DRs & CAPA in conjunction with other cell members
- Proactive generation and timely review/implementation of level 0 & level 1 change controls in conjunction with other cell members
- Proactive generation & timely approval of BNFs in conjunction with other cell members
- Autoclave load pattern re-qualification
- Support clean room openings and month end client service targets by the provision of appropriate cover – e.g. weekends
- Understand and ensure implementation of emergency procedures and safe systems of work
8
Experience For Sanctions QA Officer Resume
- Administrative release of Sandoz products under supervision of the Qualified Person
- Creation and follow-up of deviations and Quality Events
- Creation of product specific annexes of Sandoz QA agreements with batch release sites
- Warehouse collaboration (Quarterly visits)
- Timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures
- Acts as a subject matter expert for GMP compliance during root cause investigations, change control procedures and improvement activities and approves final protocols and reports
- Ensures correct administration and documentation of data in accordance with guidelines and local procedures
- Advocates safety culture within the organization
- Indicates opportunities for improvement and takes part in or leads projects in order to implement changes
9
Experience For QA Officer / QP Resume
- Acts as a mentor and coach for QA officer lvl 1
- Monitors activities concerning compliance and ensures validated status of GMP processes and systems. Ensures that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date
- Supports MSD Animal Health training initiatives (i.e. development of training modules, actual training of individuals)
- Reviews and approves deviation investigations
- Participates in internal and external audits and projects as required
- De-pyrogenation tunnel requalification
- Drive cost save initiatives
- Ensure service targets are achieved and risk is NIL
10
Experience For QA Officer Resume
- Manage the company’s Calibration Program
- Manage the company’s CAPA Database
- Generate Certificate of Analysis (CoA’s)
- Maintenance, implementation and continuous improvement of the QMS
- Bulk and Finished product batch review
List of Typical Skills For a QA Officer Resume
1
Skills For QA Officer Biologics Resume
- At least five years’ experience working in a Quality Assurance role
- Substantial experience working within a pharmaceutical quality function, preferably “steriles”
- Experience working within a pharmaceutical QC laboratory would be beneficial
- A working knowledge and practical experience with GMP guidelines
- Typically a Bsc graduate, or equivalent, with experience of cGMP and working within a quality management system
- Demonstrated knowledge and understanding of current regulatory requirements for manufacture of licensed medicinal products is desirable
2
Skills For Overt QA Officer Resume
- Sterile Manufacturing experience highly desirable
- Reviews and monitors nonconforming conditions and associated corrective actions to ensure quality program effectiveness
- Previous experience in a similar role within a Quality function within a GMP environment
- B. Pharm with 2+ years’ experience in relevant field
- Experience in the pharmaceutical industry
- Basic knowledge of GMP/GDP and work experience in a QA department
- Strong safety awareness. Able to identify potential safety risks and take responsibility in addressing the risks
- Understanding of EU & US guidelines and the product licensing processes
- Understanding of GMP requirements in relation to sterile product manufacture and packaging
3
Skills For QA Officer KYC Recertification Preparation Resume
- Understanding of the principles of sterilisation & aseptic processing
- Understanding of EU guidelines, GMP requirements, product licensing processes, Quality Management Systems and Data Integrity
- Performing & documenting non-conformance and deviation investigations
- Responding to and investigating customer complaints
- Establishing appropriate suppliers for GxP materials, including appropriate documentation
- Performing QMS activities such as deviation, change control, incidents etc 20%
- Filling of inprocess reports and water reports of softgel and injection department
- Maintaining the 5s system with respect to sops, MFR’s and master batch records
- Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.’
4
Skills For GLP / GCP QA Officer Resume
- Performing IPQA activities in shift operations
- Manufacturing, quality, QC or administrative role
- Willing to Work in Shifts (First or Second)
- Living ethics and values
- Writing formal customer reports (PQRs, stability, CT reports)
- Manufacturing batch protocol updates
- Knowledge of the quality principles and their application to engineering, environmental, procurement, construction, testing, operations or decommissioning
5
Skills For GMP QA Officer Resume
- Responsible for online verification of batch card filling, personnel following the standard operating procedures on shop-floor 25%
- Check for adherences to QSP/MFR during manufacturing process. 20 %
- Responsible for supervising the housekeeping of the department
- Support the running and day to day activities of the Eastbourne Quality Management System and core packaging operation
- Knowledge of corrective action system application to eliminate nonconforming conditions
6
Skills For Cbps AU QA Officer Resume
- Deviation and change control handling
- Plan and co-ordinate for housekeeping audits, IQA, etc. 20 %
- Responsible for trending of temperature and RH data of Softgel, Injection, Pharma Stores department
- Demonstrable knowledge of worldwide GMPs for API, drug or medical device manufacturing
- Knowledge of pharmaceutical manufacturing processes is desirable
- Resilience – ability to manage diversity and conflicting viewpoints at senior levels
7
Skills For QA Officer Kyc-associate / Senior Associate Resume
- Act as a key reference \ escalation point for all matters impacting the business
- Release of APIs, excipients, primary and secondary packaging materials
- Disposition of Icodextrin following batch release
- Generation, verification and issuing of batch related documents
- Key contact within the team for coordination of supplier change notifications, and ensuring changes are appropriately assessed
8
Skills For Sanctions QA Officer Resume
- To support manufacturing and other operations in the development, implementation and maintenance of cGMP standards
- Knowledge of regulatory requirements and functions that impact the quality program
- Proficiency in the use of applicable computer applications
- Knowledge of Bechtel’s administrative practices
- Contributes to management’s knowledge of the program by providing general feedback as to the testing industries positive and negative actions, concerns, etc
- Prepares and completes quality audit checklists and participates in quality audits of corporate/project quality program/plans including, as needed, pre-award assessments of potential suppliers and subcontractors as a prospective lead auditor or a qualified lead auditor
9
Skills For QA Officer / QP Resume
- Assesses and monitors project engineering, environmental, procurement, construction, testing, operations, decommissioning and other activities related to the quality program/plan
- Reviews and determines applicable quality requirements for inclusion in selected engineering, procurement, and construction documents
- Reviews and reports on project associated quality-related procedures and manuals for conformance to project quality program/plan requirements
- Drafts quality procedures for review, approval, and issuance in accordance with approved processes
- Drafts revisions/amendments to the corporate and/or project quality program/plans
- Reviews and reports on new or revised regulatory requirements and their impact on the established quality program
- Reviews and determines the sufficiency of corporate/project quality control inspection plans
10
Skills For QA Officer Resume
- Analyzes and recommends solutions to mitigate performance risk
- Follows up on actions taken in response to audit findings to ensure adequacy of completed corrective actions
- Maintains contact with designated client quality personnel to provide status, manage relationships, and execute applicable actions
- Provides direction and assigns work to quality specialists and others who assist on specific assignments. Reviews and checks work
- Works with and/or leads root cause analysis in conjunction with other project or staff personnel to develop corrective action plans which assist in the resolution of complex issues
- Provides input into the development of standardized metrics and responds to engineering, construction, procurement, and others who request guidance on implementation of quality requirements
- Able to work closely with the QA Manager, Lab Director, Lab Managers, Client Services and lab staff
- Document issuance and retrieval 25 %
List of Typical Responsibilities For a QA Officer Resume
1
Responsibilities For QA Officer Biologics Resume
- Excellent interpersonal skills with the ability to appropriately challenge others behaviours
- Extensive knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and exceptional situations
- Experience in API
- Quality Assurance experience in a pharmaceutical industry
- Communicating with departments with regards to manfucaturing documentation status, and performing the review and approvals
- Sterilizing filter testing
2
Responsibilities For Overt QA Officer Resume
- Line clearance for dispensing, manufacturing, coding / printing, packing, etc 20 %
- Knowledge of biological manufacturing processes
- Liase with Quality Control department to ensure timely delivery, reporting and integration of Quality Control records into the batch record
- Master’s in Chemistry (M.Sc Chemistry)
- Adequate knowledge on QMS documentation, such as Deviation, Change control
- Practise Data Integrity and Online Documentation in all plant activities
3
Responsibilities For QA Officer KYC Recertification Preparation Resume
- Involvement in the set-up of a new facility or process would be useful
- Root cause analysis & Risk Management
- Execute responsibilities associated with QMS requirements, including but not limited to timely maintainence of deviation management system records, change records, documentation systems
- Participate in and facilitate continuous improvement activities related to the role
- Perform internal and external audits as required
- Work in a team and also to work independently
4
Responsibilities For GLP / GCP QA Officer Resume
- Trilingual (Dutch, French and English)
- Business proficient knowledge of Dutch and English language is mandatory
- Strong organizational skills and ability to manage multi tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail)
- Pragmatism – Ability to make decisions in a highly complex environment that balance business needs, quality and compliance risk and other constrains
- Manage and distribute workloads
- Drive for improvement – out of the box thinker, able to manage ambiguity. Demonstrated ability to push boundaries and able to challenge status quo to uncover fresh innovation
- Review and issuance of controlled copies of SOP’S, OCP’S, and ERP’S of applicable department
5
Responsibilities For GMP QA Officer Resume
- Responsible for archival/retrieval and storage of quality documents
- Be a conscientious and a well-motivated individual
- Have the ability and desire to drive change in order to improve both the systems in which they work, and their own development
- Be able to work independently and actively participate in a team environment
- Review of batch production record, Quality control records, log books, calibration records, traceability review 30%
- Random in-process checks for verification
6
Responsibilities For Cbps AU QA Officer Resume
- Testing of the Semi finished products / Finished Products in the shop floor (Manufacturing and Packing) for pouch leakage, shipper weight, clarity of printing, moisture content analysis, leak testing of pouches, disintegration test analysis
- Issual and reconciliation of deviations and change controls in the shop floor (manufacturing , maintenance and packing area) after approval from the Manager. 20 %
- B.Pharma / M Pharma / M.Sc
- Literate / numerate to GCSE level
- Active participation in CAPA and CC systems
7
Responsibilities For QA Officer Kyc-associate / Senior Associate Resume
- Partner with manufacturing staff to ensure timely identification, assessment and mitigation of quality related issues and opportunities within the manufacturing area
- To make sure all antigen batch manufacturing records and related documents are reviewed and approved in a timely manner, including the review of any deviations relating to that record
- Liase with the Quality team, including Qualified Persons to ensure issues required their review are presented at the earliest opportunity following identification
- Regulatory /industry knowledge
- Artwork flow coordination
- Business owner of eSDMS
- Relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and/or audits
8
Responsibilities For Sanctions QA Officer Resume
- Great team environment
- Approval of artworks
- 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
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