CooperSurgical

CooperSurgical is a market leader in the development, production, and marketing of medical devices used to advance women’s health care and minimally invasive surgery. It is an exciting, ever-evolving, and significant market that touches all our lives.

We are a company on the move, and our employees are dedicated to keeping the momentum going. Our team cares enough to want to make a difference – for the communities in which we live and work and in the well-being of women.

We offer competitive compensation and a complete benefits package to all full-time employees. Explore our current job openings. Your interest in our company will be treated with respect and kept confidential. One of our human resource professionals will personally review your resume and experience with our mutual needs in mind.

Cord Blood Registry (Cbr) Technician I - Quality Control is responsible for analyzing and documenting test results from our cord blood and cord tissue processed samples, releasing raw materials, supporting the analytical and processing equipment maintenance program, conducting environmental monitoring, and providing a wide range of critical functions that support the cryogenic storage of our client’s final product. This position is also responsible for providing our internal customers with technical expertise while maintaining the highest quality services possible.

• 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, environmental monitoring 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 Microbiology laboratory activities including area cleaning, maintenance and ordering of supplies
• Support biorepository activities 
• Handle Liquid Nitrogen (LN2) utilizing personal protective equipment and good safety practices.
• 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)
• Execute BacT/Alert Testing, when needed
• 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.

Preferred Qualifications: 

• The successful candidate will have a creative and innovative approach to his or her work and will never shy away from offering frank and data driven observations and recommendations. We’re looking for a highly organized, methodical professional with the experience necessary to take our products to the next level in terms of safety, compliance and accuracy. A proven track record of experience is essential. 

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

Special Working Conditions: 

• Laboratory/Manufacturing environment in which personal protective equipment (PPE) is used
• Adhere to guidelines set forth in safety manual. 
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work hours dictated by the requirements of the lab; flexible to work alternate schedules, able to work mid-shifts, weekends, and holidays.

Physical Requirements: 

• The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• The employee is regularly required to perform repetitive tasks for extended periods of time.
• The employee is frequently required to walk; climb a ladder or step stool; sit and reach with hands and arms.
• The employee is occasionally required to stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 50 pounds.
• On occasion, employee must frequently lift and/or move up to 100 pounds with assistance.
• Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

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. 

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.