Work Model: This position will be required to work onsite

Essential Duties and Responsibilities Includes but are Not Limited to the Following:

• Adhere to Cbr corporate and Quality Control policies
• Ensure all work performed strictly adheres to cGLP/cGMP
• Exercise Good Documentation Practices (GDP)
• Use company Quality Management System (QMS), Laboratory Information System (LIS), equipment management software
• Work in a biosafety level-2 (BSL-2) work environment
• Complete and maintain records that meet regulatory requirements
• Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance
• Follow the laboratory's procedures for specimen handling and processing, reagent preparation, test analyses, reporting and maintaining records
• Notify management and initiates discrepant events in the applicable quality system
• Participate in training, projects, housekeeping, and other related activities
• Train on a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills and procedures within assigned discipline area (s) including analytical, bioanalytical and microbiological responsibilities
• Provide support during peer training
• Assist with lab investigations, deviations, corrective actions, procedure changes, method qualification planning, etc.
• Support Research and Development projects
• Support method qualifications/validations
• Support the Cbr stability program
• Support the environmental monitoring (EM) program
• Support material purchase ordering activities
• Support material inspection and release activities
• Support the everyday organization of the Hematology laboratory activities including area cleaning, maintenance and ordering of supplies.
• Perform proficiency testing and participates in competency assessments.
• Perform equipment calibration, preventive maintenance and repairs
• Perform equipment Installation, Operation and Performance Qualifications (IQ/OQ/PQ)
• Perform data trending
• Prioritize and organize work to deliver assignments according to established schedules and deadlines
• Communicate in a manner that fosters cooperation and creates a safe environment for those involved
• Provide audit preparation support activities
• Familiarity with basic statistical tools to analyze data in relation to trends results
• Capable of routinely multi-tasking
• Problem solving and troubleshooting competencies
• Make informed and timely decisions independently
• Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Apply common sense understanding when working independently on departmental projects, timelines and dealing with compliance issues.
• Wear appropriate Personal Protective Equipment (PPE)
• Maintain donor, client, and employee confidentiality.
• Provide administrative support: copying, filing, and archiving records
• Respond to environmental monitoring alarms

Additional Responsibilities:

• Capable of working with a moderate degree of supervision and organizing own time
• Support documentation generation and revisions (SOPs, work instructions, forms, protocols, reports, etc.)
• Support the Cbr compliance procedures and policies (ex.: training, incident reports, deviations, documentation)
• Train and operate at Hematology workstations (example: Sysmex, Cellometer, Vision, Flow Cytometry, BacT/Alert, etc.)

Basic Qualifications:

• Bachelor’s degree in one of the biological, chemical, or physical sciences OR Bachelor’s degree in a different science with a minimum of 1 year of relevant laboratory work experience.

Clinical Laboratory Improvement Amendments (CLIA) Responsibilities and Qualifications:

• Some staff with this job title may be required to take on additional roles (example: Technical Personnel, General Supervisor) and/or perform additional functions (example: high complexity testing) that are regulated by Clinical Laboratory Improvement Amendments (CLIA). In such cases, the Laboratory Director and General Supervisor shall determine eligibility based on additional requirements such as:
  • Internal company and CLIA baseline educational, training and experience

Please Note: As a Life Sciences company, we are dedicated to protecting the health and safety of not only our clients and communities, but our employees as well. As such, all new employees must be fully Covid-19 vaccinated by their date of hire.

Generate Life Sciences was recently purchased by CooperSurgical, a market leader in the development, production, and marketing of medical devices used to advance women's health care and minimally invasive surgery. Integration plans have begun to unite Generate and our brands into the CooperSurgical family, so that we may all continue to advance the care of healthy women, babies, and families.

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.