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Quality Assurance Specialist

Company: USLA BioLegend
Location: San Diego
Posted on: May 15, 2022

Job Description:

Job TitleQuality Assurance SpecialistLocation(s)San Diego - BioLegendBioLegend, Inc. (a PerkinElmer Company) develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology.In 2021, PerkinElmer, Inc. (NYSE: PKI) a global leader committed to innovating for a healthier world, acquired BioLegend. The acquisition, the largest in PerkinElmer's history, further expands the Company's life science franchise into high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing.Job SummaryThe Quality Assurance Specialist will perform and administer Quality Assurance (QA) activities at BioLegend, in accordance with BioLegend Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS). This position will be an integral part of the Quality Assurance team and will be responsible for documenting and processing non-conformances, corrective actions, customer complaints as well as performing product release.Essential FunctionsCreate, review, and approve QMS documentation in the company.Assure products (current and new), materials and process, including their applicable documentation, are compliant with applicable QMS requirements.Work with internal department heads to ensure implementation of uniform quality practices and share/train best practices.Work with management to ensure that the principles of quality and compliance are included in the company's culture.Support change control activities.Support the QMS training program, including ISO13485, and regulatory requirements, and act as a resource to ensure quality compliance.Support non-conforming activities, corrective and preventive action, root cause analysis, process improvement and complete resolution towards customer requests, customer feedback, inspections, audits, deviations and other related issues.Perform batch records review and product releaseConduct internal audits and investigations.Support, hosts, and leads, customer, supplier and regulatory audits, including timely document search and delivery during audits, as necessary.Responsible for creation of reports for QA, including detailed analysis.Perform other duties as assignedReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.iAct CompetenciesAccountabilityDependabilityQuality of workTeamworkMinimum Qualifications - Education and ExperienceMinimum Education (or substitute experience) required: BA /BS in Biology or related field or equivalent Three years of experience with quality assurance procedures under cGMP, ISO 9001, or ISO 13485 standards.Skills required:Thorough working knowledge of QMS documentation requirements.Excellent data management and analytical skills and ability to multi-task. Strong communication skills - written, verbal and computerExperience conducting QA auditsKnowledge of ISO 13485, and cGMP, and regulations.Flexible team player in dynamic environmentExperience with MS Word, Excel, Power point, Visio; Adobe Acrobat; ERP systemsPreferred Qualifications- Education and ExperiencePrevious experience with an electronic document control systemCondition of EmploymentConcerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, BioLegend requires proof of COVID vaccination for all U.S.-based employees (subject to limited exceptions) beginning January 18, 2022PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Keywords: USLA BioLegend, San Diego , Quality Assurance Specialist, Other , San Diego, California

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