Pharmaceutical quality assurance resume samples. Proficient in one or more GXP areas, and may be seeking skills in other GXP areas, Completes release of investigational batches (drug substance/API, Drug product, vaccines), seed and cell lines, and other development materials as per Elanco R&D Quality System requirements.Proficient in one or more types of material to release, Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies, Perform any other duties or serve in such other capacity as may be determined by Company management, Vaccine/animal health development experience, with R&D-related Quality Assurance, Ability to operate in a business focused R&D Quality organization recognized as a collaborator and partner to both the R&D organization and CRO business partners, Knowledge in one of the following: GCP (VICH GL9), GMP, or GLP compliance in one or more global regulatory requirements (USDA, CFIA, MHRA/VMD, EMA), Knowledge of PC tools including all MS Office applications and Internet, May lead small to medium scale projects with minimum to moderate risks, Knowledge of business process and the ability to work within the general business hierarchy, Aware of risk-assessment methodologies, and project organization, Ability to set priorities and manage multiple tasks, Bachelor's degree in Business, Quality Assurance, or similiar discipline, A minimum of 1 years regulated GMP industry and/or QA experience, Experience with DCA and LMS, SharePoint, and Trackwise a plus, Strong attention to detail and decision making skills, Strong analytical skills and experience with data analysis, Ability to work independently and keep up with rapid changes in priorities; to work on multiple projects without loss of efficiency and move to new projects with relative ease, Ability to gather information from a variety of sources and analyze all data to provide management with comprehensive reports, Strong verbal and written communication skills and interpersonal skills, High level of PC competence (proficiency of all software used by the company including MS Project, MS Access, MS Excel, MS Word, IE and Netscape Navigator) and an understanding of computer and database logic, Requires independent judgment and decision making in conducting audits and recommending a course of action for discrepancy resolution, Knowledge of medical and/or clinical trial terminology, Ensure compliance of Ionis’ change control and validation program with respect to Ionis’ QMS, SOPs and applicable domestic / international regulatory requirements. Now that you’re a pro at writing Quality Assurance Specialist resumes, use our Quality Assurance Specialist cover letter sample to make an equally excellent cover letter for your job search. 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. Quality assurance jobs are ruthless. Also note how the quality assurance specialist resume template for Word utilizes strong action verbs at the beginning of each line. Creating an industry-specific document, like our quality assurance specialist resume template for Word, can help you stand out from a crowd of competing applicants and secure interviews. HP UFT, Selenium), HP Quality Center/ALM, IBM Mainframe platform, file/data compare tools, Knowledge of regulatory requirements /cGMP/ ICH, Microsoft Office/Suite (Excel, Word, PowerPoint, etc. Act as the champion for product safety/quality; monitor and repost on trends alerting the Director and/or Sr. Quality Mgr, 5% Lead assigned projects in critical process monitoring and capability; working with operations, QA/QC, and plants to establish new product/process measurements and preventative control at the source, 5% Able to back up divisional formulator and create formulations in Brill software as needed, Responsible for the execution of Quality Management System and Compliance elements such as documentation, record, metrics and KPIs, dashboard, training documents, document review, standard gap assessment, Consolidated supplier overview, audit schedule and audit follow-up within SEE of the Transport & Temperature Control activities (e.g. 15-16 quality assurance cover letter samples | 626reserve.com. degree and 0- 3 years’ experience in pharmaceutical manufacturing or 4-8 years of equivalent experience, Undergraduate degree in engineering, scientific, business or QRC disciplines. Ensured Manufacturing Operations are in compliance with GMPs and Regulatory Agencies Responsible to follow Environmental Health and Safety procedure awareness. Keywords: Quality assurance CV template, relevant work experience, quality management, compliance activities, training needs, recommendations, QA skills Created Date: 1/1/2004 12:49:43 AM Home; About; Blog; Contact; Resume Samples, Interview Tips and Career Advice from an Industry Expert. The following Quality Assurance Specialist resume samples and examples will help you write a resume that best highlights your experience and qualifications. Responsible for identifying deviations in the processes that ensure all activities are cGMP compliant, identifying corrective actions, assisting with RCA, establishing path forward activities and appropriate documentation is complete. Recognize and communicate trends associated with the data over time, Resolve moderately complex investigations and events as directed by area management, Review SOPs, logbooks, and other documentation related to daily QA activities, Provide support for external regulatory or partner GMP audits, Develop and implement enhancements to Ionis’ quality system procedures, Partner with Product Development, Regulatory Affairs, Clinical Research, Facilities and Manufacturing to meet clinical project and product needs, Compile, track quality metrics for critical quality attributes and report to management on a quarterly basis (i.e., Lot disposition, Deviations, CAPA, Change Control, OOS, and audits), Working with QA Managers, maintain the QA databases for Product Genealogy, Deviations/CAPA, Change Controls and Audits, Support training events related to Intarcia quality procedures, cGMP regulations and guidelines, A minimum Bachelor’s degree in a scientific discipline is required, Strong working knowledge of cGMP regulations (for e.g., 21CFR4, 21CFR211, 21CFR820, ISO13485), and ICH guidance’s, Attention to detail in review of GMP records e.g., batch records, specifications, analytical, EM data, CoA etc, Pro-active in identifying opportunities for improvement along with strong problem solving and negotiation skills, Register Technical Product Complaints (TPCs), Opening TPCs for all SAEs, AEs, other events coming into the AER Argus system workflow, Monitoring complaints for timely follow-up, Work with investigators and contract manufacturers to ensure timely complaint investigations, Send “30 day” updates on complaint status to customers, Prepare customer letters, manage letter translations, reviews and delivery to customers, Perform trending and data analysis for meetings / reports, Provide support for Regulatory authority and customer requests regarding complaints, Provide training on the product complaint process, Identify compliance weaknesses and ensure the implementation of workable solutions, Write/revise/review SOPs/INSs as necessary, Bachelor’s degree or equivalent in a scientific discipline with a minimum of 5 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 3 years’ experience, Minimum 3 years’ experience in regulated operations, Strong understanding of the FDA QSR regulations, Medical Device Directive, ICH Q7, ISO 13485, and sterilization standards, Strong data review and technical writing skills, Direct experience with product complaint handling, including investigation and documentation, High-level understanding of scientific approach and analytical thinking of others, Strong communication skills (encompasses verbal, written, interpersonal, listening), High level of attention to detail and accuracy; very observant in order to audit properly, Flexible; ability to adapt to changing priorities, Excellent time management skills (schedules, timelines, task prioritization), Perform internal and supplier quality audits and facilitate corrective actions, Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner, Review manufacturing, QC, release records, and documentation for medical device and drug substance/drug product, Audit reports and raw data for compliance with protocols, SOPs and regulations, including design verification, stability, aging, sterilization, and validation, Participate in product development project teams, Perform supplier quality audits and facilitate corrective actions. Quality Assurance Specialist Resume Examples. Strong analytical and problem solving skills. mukesh_iitd_viney. Top 8 quality assurance associate resume samples In this file, you can ref resume materials for quality assurance associate such as quality assurance associate resume samples, quality assurance associate resume writing tips, quality assurance associate cover letters, quality assurance associate interview questions with answers… Created with Sketch. Look at these quality assurance resume examples: Quality Assurance Job Description for Resume—Examples . They must be able to identify opportunities for process enhancements while supporting existing standards with a focus towards providing excellent service to our clients. Capable of explaining technical issues to non-technical personnel, Team Work – Contributes to building a positive team spirit, Written Communication – Writes clear, accurate and concise technical and non-technical documents, Works closely with the Editorial and Quality Assurance team to ensure that curriculum in both online and offline (print and web-based) formats adheres to predetermined criteria, Assists the Manager of Quality Assurance regarding issues regarding the academic integrity of existing curriculum using database tools and documents these issues in order to capture and report this data to internal/external users, Becomes familiar with Connections Education’s general editorial style guide to perform editorial functions as necessary such as proofreading text for accuracy, consistency, etc, Works with the other functioning groups within the Curriculum department as needed, Provides regular status reports for all activities related to the project, Identifies new processes to meet the curricular demands of the program, Develops self to improve performance in current role and to prepare for future roles, and seeks and provides feedback and coaching to enhance performance; and, Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP), Reviews and compiles master production batch and control batch records, QA project lead for manufacturing campaigns, Provide validation/preventative maintenance support for critical equipment and write associated protocols, No supervisory responsibilities, but may provide training to new staff. 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