Quality System Specialist

Company DescriptionLucigen Corporation (part of LGC Biosearch Technologies) has been working to improve people’s lives by providing quality products and services to life science and healthcare professionals. Now, as part of the Biosearch Technologies family, we are continuing and enhancing this mission. Lucigen grew to manufacture and sell over 325 biomedical research products and services to customers worldwide, all under an ISO 13485 compliant quality system. Lucigen has been the exclusive supplier of the Epicentre brand products to scientists worldwide since 2017. Core competencies include enzyme and competent cell manufacture, next gen sequencing services and library preparation kits, to molecular diagnostics, applied, government and academic customers. Job DescriptionThe Quality System Specialist will play a key role on the company’s Quality Assurance team, driving and administering quality system activities in multiple areas of focus. This position will ensure effective management of key operational duties specific to quality training, change management and document control, record review and retention, customer feedback and complaint management, and monitoring and measurement of quality and business objectives. The Quality System Specialist will have responsibility for supporting the documentation, effective maintenance, and improvement of the site’s Quality Management System to maintain regulatory compliance and ISO certifications. • Conduct batch history records (BHR) reviews that include but are not limited to; completeness, accuracy, the use of good documentation practices, etc. prior to approval and product release.• May support the Complaint Change Review Board through assisting in complaint investigations and developing corrective actions to address complaints.• Promote a collaborative approach with team members, functional departments, and other LGC sites.• Monitor and report on designated quality/business metrics and creation of new quality/business metrics; assist with reporting to top management on the performance and integrity of the QMS and needs for improvement, promote awareness of quality and customer requirements throughout the organization.• Partner with Operations in developing effective Quality documents (Batch History Records and related technical SOP’s), ensuring adherence to product labelling requirements.• Coordinate with QA team members on the maintenance, execution and improvement of related QMS processes: nonconformances, corrective and preventive action, process/product deviations, training management and complaint management.• Support development, maintenance, improvement and implementation of customer facing documentation (Certificates of Analysis, User Manuals, Application Notes, Customer Quality Questionnaires) as necessary.QualificationsQualifications:Bachelor Degree in STEM field is preferred, Associates Degree is required.  2 years’ work experience in a quality role is preferred.  Educational experience in a lab will be considered. Certificate in or secondary studies in Quality is preferred. Familiarity with international Quality System requirements, particularly ISO 13485, FDA, or GMP is preferred.  Experience in a document and records control or technical writing/procedural writing role.Working knowledge of Electronic Quality Management Software (eQMS).Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process control. Additional InformationWhat we offer (US based-employees):Competitive compensation with strong bonus programComprehensive medical, dental, and vision benefits for employees and dependentsFSA/HSA Pre-tax savings plans for health care, childcare, and elder careDeductible Buffer Insurance and Critical Illness Insurance401(k) retirement plan with matching employer contributionCompany-paid short- and long- term disability, life insurance, and employee assistance programFlexible work optionsPet Insurance for our furry friendsEnhanced Parental leave of 8 additional weeksPTO that begins immediatelyTown Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!