Quality Assurance Coordinator

Posted Yesterday
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San Diego, CA, USA
In-Office
26-34 Hourly
Entry level
Biotech
The Role
The Quality Assurance Coordinator supports QA processes including non-conformances, risk management, and compliance. Responsibilities include document management, audit support, and data preparation for reviews.
Summary Generated by Built In
Job TitleQuality Assurance Coordinator
Location(s)
San Diego - BioLegend

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity 

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.  

  • 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, supplier Management and validation. 

  • Reviews quality records for all related areas of responsibility. 

  • Demonstrates the ability to work with limited direction and can prioritize projects independently 

  • Responsible for personal daily task management, training plans and performance management. 

  • Assist with generating, reviews and maintains QMS documents. 

  • Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs). 

  • Assists with data preparation for Quality Management Reviews. 

  • Provides administrative support for external audits (regulatory or customer) and Internal Audits. 

  • 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. 

  • Assist with monthly and management review data and metrics for areas of responsibility. 

  • Other projects or responsibilities as may be required. 

Minimum Qualifications  Education and Experience 

  • Bachelor's degree in a scientific discipline or equivalent work experience. 

  • 1-year work experience in quality assurance

  • 0-6+ months of experience with GMP or similar regulated products. GMP/GLP proficiency.   

    Preferred Qualifications – Education and Experience 

    • IVD, MDSAP, ISO 13485 or similar compliance experience 

    • Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat (PDF) 

     

    Work Environment & Physical Demands 

    Office 

     

    While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment. 

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

    While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear. 

    The base salary range for this full-time position is $26.20 - $34.00/hour. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. 

    Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

    What do we offer?

    We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

    • Medical, Dental, and Vision Insurance Options

    • Life and Disability Insurance  

    • Paid Time-Off

    • Parental Benefits

    • Compassionate Care Leave

    • 401k with Company Match

    • Employee Stock Purchase Plan

    Learn more about Revvity’s benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.

    *For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.

    Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability—or unable to use—the online application system and need an alternative method for applying, you may contact [email protected].

    Top Skills

    Adobe Acrobat
    Glp
    Gmp
    Excel
    Ms Powerpoint
    Ms Word
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    The Company
    Waltham, , Massachusetts
    3,109 Employees
    Year Founded: 2023

    What We Do

    At Revvity, “impossible” is inspiration, and ""can't be done"" is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Learn more at www.revvity.com

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