at Acara Solutions in Newark, Delaware, United States
Acara Solutions is looking for a Microbiology QC Lab Technician for our Client located in Newark, DE.
Microbiology QC Technician is part of the Quality Control team, focused on obtaining and testing of samples from manufacturing areas and various production support systems.
Responsibilities includes but not limited to: sample acquisition, testing, Good Documentation Procedure, Good Manufacturing Procedure and performing training.
As needed, technician may provide process and technical details on testing data and system in compliance to FDA requirements regarding product release.
Completes manufacturing related microbiology and environmental testing and processes related to the manufacturing of reagents and calibrators for diagnostic assays, related to the Dimension, Vista, Atellica, Stratus CS;
Leads complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment and/or processes.
Enters data into internal computer systems and generates documents as required;
Interacts with others inside/outside work group: scientists, engineers and management;
Potential to work independently on projects including defining tasks, setting priorities and planning materials;
Understands the quality management system and ensures that their area complies with FDA, ISO and IVDD standards.
Pay and Benefits:
The salary for this position is $30.07 per hour.
Required Skills / Qualifications:
BS degree in microbiology or Biology or Biochemistry
Minimum of 8 years" experience in Laboratory Technician
Preferred Skills / Qualifications:
Knowledge of root cause investigations and performing Corrective actions.
Microbiology, bioburden testing, environmental testing, analytical instrumentations.
Diagnostic Instruments and Clinical Instrument Testing: Atellica, Dimension, Vista, IMT, Stratus, Syva, ADVIA.
Laboratory skills: operation, maintenance and troubleshooting of analytical instruments and chemistry assays.
LIMS aspects: user training, troubleshoot various LIMS and Network issues.
Trained in laboratory sciences, physical sciences and how data is generated and used
Diagnostics Medical Device: Quality Systems and Quality Change Processes
May provide advice, training, and technical assistance to support staff and train lower level employees.
Mathematical skills: concentration calculations and statistical analysis;
Computer skills: customary MS Office programs, SAP, LIMS, and Siemens Clinical testing software.
Ability to work independently;
Good communication skills, both written and verbal;
Flexibility to work overtime and irregular work hours as needed
Knowledge of and experience in handling bio-hazard materials;
Knowledge of QSR"s and ISO standards.
Position may require participation in new product development, production support and reference materials.
Operates and performs adjustments to lab equipment and instruments.
Performs quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.
Performs periodic inspections of equipment and performs preventative maintenance work.
Performs troubleshooting test processes. Performs complex calculations as well as prepares graphs and charts.
Upon offer of employment, the individual will be subject to a background check and a drug screen.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.