Abbott Rapid Diagnostics is part of Abbott’s Diagnosticsfamily of businesses, bringing together exceptional teams of experts andindustry leading technologies to support diagnostic testing which providesimportant information for treatment and management of diseases and otherconditions.
The position of Quality Molecular Analyst is withinour Infectious Disease Developed Markets business unit located at Scarborough,Maine. In this role you will perform work required to ensure Company productquality is maintained at standards set forth by Company Quality System andmandated by regulatory agencies such as the FDA, ISO, and USDA. The focus areasfor a Quality Scientist include but are not limited to: troubleshooting; aid in transfer of new processes and technologiesinto the QC department; developing methods; in-process and final releasetesting as needed.
This job description will be reviewed periodically and issubject to change by management.
Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned.
• Support specific projectsand assist in developing new processes
• Performsin-process and final release testing
•Observes all safety policies and report.
• Investigates problemareas and areas of desirable product improvement.
• Reports any and allsafety policy violations.
•Participates in all departmental ergonomic programs.
•Represents QC at cross functional meetings.
• Aidsin the transfer of new processes and technologies into the QC department.
•Works closely with QC Management to ensure all departmental objectives are metor exceeded.
•Identifies Quality gaps and process inefficiencies and recommend solutions.
• Trains new and currentQuality Control technicians as needed.
• Initiates and authorsQuality Incidents (QI).
•Reviews/approves new and revised Standard Operating Procedures.
•Provides support for technical and quality issues.
•Communicates quality issues to QC Management in a timely manner.
•Maintain Good Laboratory Practices (GLP).
Supervisory Responsibilities Doesnot directly supervise employees
Other Knowledge, Skills andAbilities
•Practical laboratory skills
•Ability in mathematics and computer literacy
• Goodcommunication skills, capable of communicating ideas to colleagues andcustomers
•Problem-solving skills combined with analytical skills and good attention todetail
•Project management skills and good organizational skills
• Goodknowledge of science and the ability to apply basic principles and techniques
•Attention to detail a must
•Ability to solve practical problems and deal with a variety of concretevariables in situations where only limited standardization exists
BASIC QUALIFICATIONS ANDEDUCATION:
•Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry or a relateddiscipline with 2+ years industry experience.
•Experience running PCR or isothermal replication methods
•Experience with QC/QA compliance documents
•Strong collaboration, team working skills and communication skills
•Independentlymotivated and detail oriented with good problem solving ability
•Experience with GMP, FDA, ISO and USDA regulations
•Demonstrated competency related to RCR and Gel Electrophoresis testing.