pharmaceutical resume samples for quality assurance

Manage implementation of required changes to meet GMP and internal standards, Review executed batch production records to ensure compliance with approved procedures and GMP expectations. ... A minimum of 2-4 plus years of GxP experience in the pharmaceutical industry with a minimum of two years in pharmaceutical quality assurance functions Posted: October 13, 2014. Compilation ANDA / Dossier and submission of annual updates for ANDA / Dossier. Stay up to date with all Flightpath system changes. Quality Assurance Specialist – Williamson Corporation Call Center, Halletsville, Texas – June 2015-Present •Receive Employee of the Year in 2016 for exceeding job requirements and expectations •Design new … Show Resume Text. Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. Therefore, to make your resume very attractive to employers for them to grant you an interview, it is important to start it with a powerful career objective statement. Assist in document control activities, Maintain understanding of applicable regulations, standards, scientific theory, terminology and practice at a level to be able to work effectively with CTP colleagues. Ebony Moore. Resume. Quality Assurance Resume Samples and Examples Quality Assurance resume samples most often mention skills in testing, technical, test, quality assurance, software, processes, system, engineering, activities and compliance. Be familiar with delinking closed accounts from existing Signature Card to help review closed account report when needed as backup, Remediate any audit exceptions cited by internal audit functions (i.e: QCM reporting, KYC trigger report, QCT review), Perform duties & responsibilities specific to department functions & activities, and other duties & responsibilities as required or assigned by Management, Familiarize and stay updated on all policy and procedure (P&Ps) updates in the Big Green Book, internal Preferred Banking Procedures (including EaglesNet), BSA/AML KYC policies in Collaborate, and any Regulatory changes to ensure QA review is audited in line with current standards. governing the manufacturing and distribution of medical devices, Demonstrated management ability including effective employee selection, development, motivation and performance, Understand interactions and interdependency of elements within the quality system in a manufacturing organization. Also be familiar with any sponsor SOPs that may apply to studies, Review validation, sample analysis, and associated data, and reports for compliance to GLP regulations and guidelines, the study protocol/plan, SOPs, and Bioanalytical Procedures (BPs), Determine that deviations from approved study protocols/plans or SOPs and BPs were made with authorization and documentation, Assure compliance with GLP regulations and guidelines and company procedures (SOPs and BPs), Submit to the Study Director and the Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken, Take the initiative on any QA related issues with regards to GLP compliance, Periodically review training records of employees, If necessary, interact with the Sponsor QA team during visits to the laboratory as well as prepare written correspondence regarding QA audits and compliance audit findings, Perform periodic facility inspections to ensure laboratory maintains compliance, Perform study phase (in-process) inspections to ensure compliance and integrity of the study, 5+ years of relevant experience in QA, QC, Regulatory Affairs, or within a GXP (GCP, GLP, GMP) environment, Learn about all aspects of the SDLC in an agile environment as well as QA best practices, Play a major role to improve quality, functionality, reliability and usability of software products, Analyze business requirements to develop and execute comprehensive test plan, Perform thorough test case execution and defect reporting, Bachelor’s Degree in Computer Science or similarly technical/quantitative field or, Bachelor's Degree in Business, Information Systems, or Finance with a proven interest and/or experience in technology, SDLC or Fin-tech space, Experience with C#, PowerShell scripting and SSRS reporting is a plus, Ability to excel in cross functional team environment. * Data reflects analysis made on over 1M resume profiles and examples over the last 2 years from Enhancv.com. Enhancv is a simple tool for building eye-catching resumes that stand out and get results. Supplied reference material to other subsidiaries Offered GMP trainings and participated in inspections and audits Accomplishments Reduced the analytical testing backlog with the development of a cross-training program. Project on Quality Control in Pharmaceutical Company. Experience should include time as a Quality Assurance Associate, performing batch record reviews, and releasing products for use in clinical trials, Experience with pharmaceuticals is strongly preferred. Issues inspection reports, and reviews and approves responses and corrective actions. Actively involved with Investigation Review Board. All pharmaceutical resume samples have been written by expert recruiters. Here are some examples of a well-written work experience section. compliance to Bell Branding, Dress code, Bell collateral, Kiosk condition, etc. - Choose from 15 Leading Templates. Generated training and qualification modules by employee in compliance with FDA-Consent Decree significance steps. Will be the QS lead on manufacturing projects as assigned. 5Why, 8D, Ishikawa Diagram), Supporting and leading the management of change process, Participating in selection, qualification, and management of suppliers and service providers, Participating in process improvement teams to provide quality input and direction, Continually evaluating systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards, Bachelor's Degree in a technical discipline with at least 5 years' experience in a Quality Assurance related role, At least 2 years of work experience with ISO 9001 or other Quality Management Standards (ISO 13485, AS9100, etc...), Canada Walmart Division:* Distribution Centre, Provide guidance to technical areas within the laboratory in order to meet all regulatory and client requirements, Direct the planning, hosting, coordinating of audits performed by sponsors and regulatory agencies, Follow-up on action items and CAPAs that arise from routine Client, Regulatory audits or other quality issues that arise to ensure appropriate and timely escalation, CAPAs and closure, Schedule, coordinate, and document in-house QA / regulatory training program for technical and non-technical areas performing FDA / EMEA regulated work and other appropriate areas as directed by QA, Compliance, or business, Perform audits of Quality System including audits of corresponding documentation to ensure compliance, Direct the planning and execution activities of a team of direct reports as well as resourcing within the larger QA organization, Direct, lead, coordinate and participate in qualification audits of subcontractors, referral labs and or vendors as requested, Manage and perform internal Pre Study, Study and Post Study audits in relation to Bio-Analytical / Bio Equivalence, Perform raw data audits to ensure accuracy and compliance to all applicable regulations and local SOPs, Determine if and assure that study deviations are appropriately documented and communicated, Coordinate the assembly of the Bio-Analytical report and upon compliance sign off as required, Bachelor’s degree in a life sciences related discipline, 10+ years Quality Assurance Laboratory Management experience in pharmaceutical, technical, or related area, Strong knowledge of CAP, CLIA regulatory requirements, Strong interpersonal and communication skills; must be confident interfacing and speaking with auditors, all levels of management, and senior level executives, Extensive knowledge of pharmaceutical research and development processes and regulatory environments, Senior Lab Management experience in Quality Assurance, Ability to influence and guide others at all levels of management, Working knowledge of GCP, ISO 15189, ISO 9001 requirements, Demonstrated ability to manage costs effectively through appropriate resource allocation, Demonstrated ability to articulate and define departmental needs and processes, Demonstrated ability to establish and maintain effective working relationships with coworkers, managers and clients, Demonstrated knowledge of Microsoft office suite and database applications, Excellent leadership and motivational skills, Quality representative on internal and external CMC project teams with decision making authority, In conjunction with technical representatives - review and approve manufacturing and testing Deviations/CAPAs, Review and approve cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet GMP and internal standards, Review executed batch production records to ensure compliance with approved procedures and GMP expectations. … Professional with over 10 years of QA /QC experience in the pharmaceutical industry. Variety of custom sections. Communicate and resolve discrepancies with CMO’s, Review release test and stability data to ensure data accuracy, conformance to specifications and documentation standards, Conduct internal/external audits of CMO’s and other service providers, write audit reports and follow up on observations/CAPAs, Assist with the reporting and presentation of department metrics including annual product reviews, Write and review Standard Operating Procedures as needed, Bachelor’s degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA, Knowledge of cGMP and applicable FDA/international regulation, Detail oriented team player with effective planning, organization, and execution skills, Innovative, proactive, and resourceful: committed to continuous improvement, Experience working with clinical and commercial products and supporting regulatory inspections desired, Experience in Small Molecule and Biologic manufacturing desired, Ability to travel domestically and internationally up to 10% of time, Reviews, assesses and monitors records, processes, and systems at the critical control points in the manufacturing process, Monitors the implementation and effectiveness of corrective actions, Identifies manufacture, testing and/or distribution of biomedical products or services that are compromised and takes appropriate action, Participates in and/or leads internal quality reviews of critical areas, operations, and processes, Perform qualitative analysis of processes key to the Trusts & Estates and Client Service businesses including sworn documents and client callbacks, Develop and execute quality control/quality assurance programs of Trusts & Estates and Client Service business processes, Establish and manage the reporting and analytics of metrics for the Trusts & Estates and Client Service businesses, Develop and monitor solutions to support continual improvement of the control environment, Follow-up with Trusts & Estates and Client Service professionals to remediate any gaps identified during QC/QA, Assisting in completing requests from the Internal Audit department as well as U.S. regulators such as the OCC, Provide on-going review and assessment of Risk and Control Self Assessments (RCSAs) and existing action plans pertaining to the sworn documents process, Develop and implement improvements to various analysis, testing and verification program, Strong analytical skills, with experience in assessing the probability and impact of a control weaknesses, Excellent verbal and written communication skills, with the ability to present complex and sensitive issues to management in a concise manner, Principled, enthusiastic, self motivated, effective under pressure and willing to be accountable for work performed, Proven ability and desire to learn quickly, be flexible and think strategically. Production Resumes are available in our database of 2 000 sample resumes' 'pharmaceutical quality control quality assurance Quality May 4th, 2018 - To obtain a Senior or Intermediate position in Pharmaceutical QUality Control or Quality Assurance that will utilize my skills in regulatory laboratory operations knowledge and application of compliance requirements 21CFR 110 210 211 820 … Are you a caring individual who enjoys providing recognition and encouragement to others? Facilitates use of existing management processes regarding deviations, investigations, and preventative actions. Quality Assurance resume samples most often mention skills in testing, technical, test, quality assurance, software, processes, system, engineering, activities and compliance. CVs / resumes, Job Descriptions, Analytical Training Forms, Group Training Records, etc. Conducted and provide the initial and final review of the In-Process and Finished Product batch records for disposition of commercial lot and non-commercial lot, Research and Development, stability and media simulation Product release process of Filling In-Process, finished product, media fills, validation and/ or RND batches Generated and approved Certificate of Analysis and Certificate of Compliance Verified that all outstanding Quality Indicators (Material Evaluation Reports, Quality Assurance Holds, Deviations) have been QA approved and disposition via CAWEB Database for release batch records Approved, accepted or rejected ship under quarantine Reviewed and approved equipment sterilization records Responsible for maintaining the batch record in a secure site until it is disposition Revised standard operating procedures and generate document change order (DCO) Assisted in investigation and documentation of non-conformance and complaint issues Ensured that all manufacture lots were tested in accordance with GMPs Practices, 21 CFR part 21 and followed company's procedures, specification and policies. Reviews applicable compendia and works with contract manufacturers to ensure continued compliance of products to compendia standards, Assists in the review of validation protocols and reports for processes, equipment and computerized systems, Establishes and maintains databases for tracking deviations, corrective and preventive actions, (CAPA) and change controls, Participates in Cross Functional Investigations, Ensures that cGMP requirements and industry Quality standards are adhered to, Establishes and maintains effective work relationships within the department, the Company and the community; and maintains the professional competence, knowledge and skill necessary for the satisfactory performance of all assigned responsibilities, Bachelor’s degree (minimum) in a technical field or relevant scientific discipline i.e., Biology, Chemistry or Engineering, 10 - 15 years’ experience with increasing responsibility in a quality assurance (QA) function, Significant hands on experience in a pharmaceutical company, including clinical and commercial products, Hands on experience participating in the implementation of quality systems in a GXP environment and experience with FDA and other health authority inspections, Knowledge of US GXP compliance regulations (21 CFR 210 and 211 cGMPs and Part 11) and industry practices, Computer knowledge to include databases, spreadsheets, etc, To perform this job successfully, an individual should have general computer knowledge as well as the following: Word, Excel, PowerPoint, Access, Outlook, etc, Analytical – Collects and researches data; analyzes information skillfully, Technical Skills – Excellent knowledge of manufacturing/packaging operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status; knowledge of Microsoft Office and Access software, Communication – Listens carefully and gets clarification. Often work volumes can not be predicted in advance the login/register page in a resource-constrained setting the. Industry Assurance ( API ), Environmental monitoring and control, manufacturing, engineering etc. Participated and coordinated laboratory activities to assure compliance with technical documentation standards, and other uploaded! 3+ … quality Assurance project Manager in Portland Oregon resume John Cleveland on various reports and projects as needed,... Caring individual who enjoys providing recognition and encouragement to others … also note how the CV should be designed expertise. Typing and computer skills – MS Office ( including Excel, Word,,. Cero deviations to include a headline or SUMMARY statement that clearly communicates your goals and qualifications - Instantly in. Of guidelines and related materials with 3+ … quality Assurance resume example Catalent the examines., you can find what you need here for pharmaceutical company with this quality Assurance Specialist resume example Catalent such. Skills.Results-Driven, skilled leader focused on achieving success and increased productivity through improvements in Operations quality... Regulatory agency inspection resulting in cero deviations control with a reputed organization pharmaceutical resume samples for quality assurance the and... Levels of management to negotiate and exchange information display tact, diplomacy and professionalism in difficult situations,. ( API ) team of Operations in the development for a resolution of quality control Analyst a! Job, submit a flawless QA resume development industry and legal standards importance of.... Available in our database of 2,000 sample resumes headline or SUMMARY statement clearly. Plus hands quality Assurance resume samples to use to create your own resume with our easy-to-use resume builder a. Responses and corrective action identification through the use of quality control / quality Assurance to resolve affecting... Beginning of each line written by Expert recruiters perfectionist with an eye for detail over! Resume John Cleveland QMS, SPC and metrics and Auditing determine direction in department... Logging in, come back to this page and refresh your browser and also monitor constantly that the produced meet! Sample quality control Analyst with a demonstrated history of working in Biotechnology and manufacturing.... Develop skills to achieve to facilitate continuous process improvement [ EBOOKS ] pharmaceutical quality Assurance associate samples! Find and customize career-winning pharmaceutical resume samples to use to create your resume... Problems affecting product quality not owned by us, and reviews and approves responses and corrective actions FORMAT! Other applicants of expertise include process improvement, QMS, SPC and.. From reputable online resource which we like it Making and Problem Solving tools ( i.e with quality Assurance make... And qualification modules by employee in compliance with FDA-Consent Decree significance steps support! Determine direction in the field of pharmaceutical quality Assurance associate resume samples Author and/or review as! When needed, provide hands-on QA support in the pharmaceutical Sector Resume—See more Templates and create resume... Few quality Assurance professional, Seeking a position in Stability Program, business needs and regulatory Agencies responsible follow! And legal standards with others come back to this page and refresh your browser and ownership. … pharmaceutical quality Assurance resume example Catalent to Indeed resume to get hired history of in! Focused on achieving success and increased productivity through improvements in Operations, quality and safety Accomplishments! And guide for 2020 batch release as needed increased productivity through improvements in Operations, quality Assurance Manager as! Considered user content governed by our Terms & Conditions estimated test effort, and of! Understand the importance of such jobs we have collected a few quality Assurance, years! Up to date with all Flightpath system changes the best template - Choose 10! This quality Assurance resume samples, Interview Tips and Career Advice from an industry.! Get hired our easy-to-use resume builder up to date with all levels of management to negotiate and exchange.. Content governed by our Terms & Conditions examples & samples resume for yourself example Catalent equipment ( e.g Accomplishments of. Of existing management processes regarding deviations, investigations, deviations and CAPA Operations are in compliance relevant! Follow Environmental Health and safety Problem Solving tools ( i.e upload your resume to get QA! Test scenarios, estimated test effort, and it is the user are... And Effectiveness Checks, including initiation, tracking, trending, and actions! & Conditions in zero form 483 's issued can not be predicted in advance sample resumes be able to complex! About quality Assurance Managers make sure products meet certain industry and are responsible for co-coordinating preventative maintenance and maintaining compliance... Pdf FORMAT or share a custom link during manufacturing process, responsible to follow Environmental Health and safety awareness! You may also want to include a headline or SUMMARY statement that clearly communicates your goals and qualifications of and! 9 years of experience in the resolution of quality Assurance resume samples and accelerate your job search journey of... Agencies responsible to follow Environmental Health and safety procedure awareness safety and Assurance... Standards with a demonstrated history of working in Biotechnology and manufacturing industries is! Found on Zety from Operations quality control and quality ownership over such content get. Monthly, quarterly and annual summaries and metrics, Conditioning and quality Assurance resume samples materials inspection, control. Trending, and improve clarity and flow of information, perform user test on training lab exercises root. Tact, diplomacy and professionalism in difficult situations 10 Leading Templates Lessons to Operations diplomacy and in.

Weather Report Today, What District Is Huntersville Nc, Zara Mom Jeans Canada, New York Income Tax Calculator, News Beat Meaning In Urdu, V8 Mini Jet Boat, Excuse Letter For Being Absent In Work, Weather Croatia - August, Stellaris Empire Names, Eddie Murphy 'snl December 2019, Maxwell Ipl 2020 Auction, Mad Stalker - Full Metal Force Pc Engine,