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Quality Assurance Coordinator

San Diego, California

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Responsibilities

Location San Diego, CaliforniaUS Job ID JR-029295

BioLegend, 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 Summary

BioLegend’s Quality Assurance Coordinator is responsible for supporting applicable Quality Assurance processes which may include non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing and validation under direct supervision. This role requires strong attention to detail, the ability to communicate and a willingness to adapt to changing business needs.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Responsibilities may include some or all of the following:

  • Acts in a support capacity for critical QMS processes such as non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing and validation.
  • Reviews quality records for all related areas of responsibility.
  • Responsible for personal daily task management, training plans and performance management.
  • Generates, reviews and maintains QMS documents.
  • Responsible for monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
  • Assists with various forms of customer support (ex. Inquiry responses, customer surveys, declarations of conformity).
  • Assists with data preparation for Quality Management Reviews.
  • Provides administrative support for external audits (regulatory or customer).
  • Participates in the use of the eQMS system and expanded applications as appropriate.
  • This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
  • Other responsibilities as needed.

iACT Competencies

  • innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development
  • Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
  • Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support
  • Transform – Adapt, learn, re-invent and change for future development and growth

Minimum Qualifications Education and Experience

  • Bachelors degree in scientific discipline or equivalent experience.
  • 1+ years Quality Management System (QMS) experience working in a regulated Good Manufacturing Process (GMP) environment

Preferred Qualifications – Education and Experience

  • 1-2 years experience in IVD, including  ISO 13485:2016 and MDSAP.

Condition of Employment

Concerns 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, 2022

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PerkinElmer 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.

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