Qa Coordinator Jobs

BioLegend, Inc. (a Revvity 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.

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:

• Responsible for personal daily task management, training plans and performance management.
• Participates in the use of the eQMS system and expanded applications as appropriate.
• Assists with data preparation for Quality Management Reviews.
• Provides administrative support for external audits (regulatory or customer).
• Assists with various forms of customer support (ex. Inquiry responses, customer surveys, declarations of conformity).
• Generates, reviews and maintains QMS documents.
• Other responsibilities as needed.
• Responsible for monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
• Reviews quality records for all related areas of responsibility.
• This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
• 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.

iACT Competencies

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

Minimum Qualifications – Education and Experience

• Bachelors degree in scientific discipline or equivalent experience.
• 2 years QMS experience working in a regulated, GMP environment

Preferred Qualifications – Education and Experience

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

The base salary range for this full-time position is $28-$34/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.

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.