Internships

Atossa Genetics is a women’s healthcare company specializing in the development of proprietary medical devices and laboratory services to stratify, assess, profile, and monitor the breast health in patients.

We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to internship@atossagenetics.com.

Current Opportunities

LABORATORY MANAGER

The Laboratory Manager will provide administrative and technical skills necessary in assisting the Medical Director with organizing, supervising and coordinating the various functions in the Cytopathology and Molecular Laboratory.

Essential Duties and Responsibilities include the following.  Other duties may be assigned.

  • Coordinates and directs the daily laboratory procedures.
  • Assists in various administrative functions.
  • Supervises the cytopreparation laboratory.
  • Supervises the cytopathology computer network system.
  • Supervises, trains and evaluates cytotechnologists I and II’s and medical technicians and laboratory assistants.
  • Analyzes, resolves, and assists personnel in handling work problems.
  • Prioritizes and schedules work assignments for cytotechnologists and laboratory techs.
  • Administers personnel policies such as sick leave, vacation, transfers, promotion, discharge and other disciplinary measures.
  • Accurately and efficiently makes certain screens breast cytology and immunocytochemistry slides are performed.
  • Revises and develops new cytology techniques.
  • Active in designing, implementing and documenting the quality assurance program.
  • Adheres to internal controls established for department.
  • Prepare documents for Lab compliance for CLIA, CAP, and other state or federal agency.
  • Maintain regulatory and compliance requirement.
  • Participate and Responsible for quality management meetings.
  • Assist in clinical trials.
  • Collaborate with other departmental needs and company operation requirement.

Education, Experience and/or Skills Required

  • Bachelor’s degree in related field
  • Minimum of three (3) years of experience
  • CT-ASCP certified
  • Experience with non-gyn breast cytopathology is a plus

To apply for this position please send your resume to hr@atossagenetics.com.

QUALITY/REGULATORY AFFAIRS TECHNICIAN

Under the direction of the Manager, Quality Assurance/Regulatory Affairs, this position will provide Quality System and Regulatory Affairs support and guidance to the Operations, Engineering, QA/RA, Clinical and Sales teams.

Essential Duties and Responsibilities include the following.  Other duties may be assigned.

  • Reviews and approves work for inclusion in complaints, Medical Device Reports (MDRs), adverse events and audits and assists in the management of actions and tasks which support these activities.
  • Assists and participates in corrective and preventive actions (CAPA)-related activities.
  • Assists and handles document control activities.
  • Communicates issues or developments identified during quality assurance activities and provides recommended improvements to responsible functional areas.
  • Assists in the ECO/DCO process, Label Reviews and provides guidance to product development teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective medical devices.
  • Periodically reviews the suitability and effectiveness of the quality system with management. Analyzes data from various sources (including, but not limited to: Non-Conformances, Complaints, etc.) to drive decision-making and effective corrective/preventive actions.
  • Assists in maintaining documentation associated from nonconformance’s, complaints, audits etc. to ensure documents for the QMS are properly maintained
  • Recommends, leads, and/or supports projects for improvements to the Quality System.
  • Assists functional groups during FDA Inspections, ISO audits etc. to provide objective evidence required during those activities
  • Ability to communicate and/or liaison effectively with various regulatory bodies (FDA, ISO, NRTL etc.)

Education, Experience and/or Skills Required

  • AAS in engineering/business related area or equivalent experience in a medical device environment.
  • 2-5 or more years of relevant medical device industry experience with Class I, II, and III devices
  • Comprehensive knowledge of Quality concepts, regulatory compliance requirements and tools including ISO 13485:2003, FDA QSRs, Medical Device Directives, Canadian Medical Device Regulations, etc.
  • Completely proficient in product & process development concepts, including change control and risk management.
  • Applies organizational and technical knowledge to move teams through issues.
  • Problem solving abilities applying statistical techniques to address issues and investigations.
  • Excellent written and verbal communication skills including ability to communicate technical information. Must be fluent in English
  • ASQ Certification or similar preferred.
  • Knowledgeable of MS Office to include PowerPoint & Excel – knowledgeable of creating charts, graphs and statistical analyses.

To apply for this position please send your resume to hr@atossagenetics.com.

LABORATORY AND DATA ENTRY ASSISTANT (PART-TIME)

The Laboratory and Data Entry Assistant performs case accessioning and transcription for medical reporting, cytology sample preparation, and laboratory equipment, reagent, and daily logbook maintenance. This is a part-time position, with the required hours of 10:00am – 2:00pm)

Essential Duties and Responsibilities include the following.  Other duties may be assigned.

  • Accession cases received
  • Transcribe case reports
  • Label slides and specimens
  • Perform protein and non-gyn stain; photograph ForeCYTE filters
  • Coverslip slides, maintain slide files
  • File processed specimens
  • Maintain all staining reagents and supplies
  • Daily laboratory disinfection of work areas
  • Daily equipment maintenance, per compliance requirements
  • Daily record keeping, per compliance requirements
  • Weekly supply inventory
  • Other tasks as needed for laboratory operations

Education, Experience and/or Skills Required

  • High School diploma/GED
  • Must be proficient in reading, writing, speaking and understanding English
  • Awareness of handling bio hazardous materials and following established safety guidelines
  • Familiarity with laboratory information systems [LIS]
  • Previous experience working in a clinical laboratory environment preferred
  • Laboratory Assistant, Medical Assistant, and/or Phlebotomy certification desired

To apply for this position please send your resume to hr@atossagenetics.com.