The Quality Assurance Coordinator will be a multi-faceted and integral part of the Quality Assurance team and 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) and support the upcoming ERP system deployment.
Job Responsibilities:
The QA Coordinator will be responsible for processing document control requests as well as assisting with the ongoing ERP project as needed, while supporting document control duties and training processes within current eQMS system (Smartsolve) as needed.
Responsible for working with one or more of the following quality system processes: document control and training.
Interacting with other QA departments and processes: change management, nonconformance, complaint management, CAPA management, supplier quality management, internal audits, post-market surveillance and vigilance management, risk management, QA product release and QA design control responsibilities.
The QA Coordinator is responsible for ensuring quality systems procedures are followed and records are compliant in their applicable areas of responsibility.
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.
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.
This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
Participates in the use of the eQMS system and expanded applications as appropriate.
Assist with monthly and management review data and metrics for areas of responsibility.
Qualifications:
BA in a scientific discipline or equivalent work experience.
1-year work experience in quality assurance. Experience with GMP or similar regulated products. GMP/GLP proficiency.
Qualified individuals must also be proficient in computer word processing using Word and in other data analysis and presentations programs such as Excel, and PowerPoint.
The QA Coordinator should possess strong organization skills and attention to detail and accuracy and they must be self-motivated, able to multi-task, and work effectively in a fast-paced environment; Good communication and interpersonal skills are essential in interactions with employees and others.
The QA Coordinator must be a fast learner with the ability to quickly analyze and solve problems.
This role requires some work experience and knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD).
Proficient in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)