At Abbott, diverseideas, perspectives, and expertise allow us to create the life-changingsolutions that help people live healthier lives. In 150 countries and withbusinesses spanning nutrition, diagnostics, medical devices, and brandedgeneric pharmaceuticals, Abbott offers you enormous opportunities to exploreyour interests and help you achieve your career and personal goals.
Wehave an exciting opportunity for a QualityAssurance Technician within our Abbott Rapid Diagnostics business locatedin Scarborough, ME . In this role, you will ensure compliance withapplicable regulatory requirements.
AbbottRapid Diagnostics (formerly Alere) is part of Abbott s Diagnostics family ofbusinesses, bringing together exceptional teams of experts and industry leadingtechnologies to support diagnostic testing which provides important informationfor treatment and management of diseases and other conditions.
Conductproduct testing, including complaint and stability samples.
Responsiblefor maintaining Good Manufacturing/Laboratory Practices (GMP and GLP).
Generateproduct testing results reports.
Reviewproduction batch records (DHR's) for accuracy and completeness in-order toapprove intermediate products for use in production. Review finished goods batch records. Report all deviations in these records andassures these have been addressed and resolved prior to issuing approval.
Conductspot-check inspections/audits of production operations
Participatein the internal audit program
Write,review and approve Standard Operating Procedures (SOPs) as necessary
Assistin supporting the Document Control program, record retention areas, and sampleretention areas
Qualifications BASIC QUALIFICATIONS
Bachelor'sdegree in a scientific or technical area orequivalent combination of experience and education.
Experienceusing database software; Internet software; Inventory software; Spreadsheetsoftware and Word Processing software.
One yearin quality assurance role in medical device industry.
Understanding themanufacturing processes of Company products and ability to recognize deviationsfrom approved documented procedures