Stem Cell Processing Project Lead

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to womens healthcare providers including testing and treatment options.

CooperSurgical is a whollyowned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical headquartered in Trumbull CT produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found at .

Job Summary:

Cord Blood Registry (Cbr)Stem Cell Processing Project Leadis responsible for providing our internal customers with technical expertise while maintaining the highest quality services possible while performing Stem Cell processing and associated projects tasks.

In this role theStem Cell Processing Project Leadperforms focused baseline responsibilities in support of stem cell processing with an emphasis on key area(s) of specialization overseeing the design implementation anddelivery of processes programs and policies. The key areas of specialization include but are not limited to the following: Employee Safety Audit Preparation Training New Technology/Process Transfer Validation Equipment Qualification Process Improvement Projects and Data Review.

Essential Functions & Accountabilities:

Stem Cell Processing:

Process client samples at all workstations trained and certified to maintain a flexible production workforce as necessary.

• Independently perform assigned duties in compliance with internal policies processes and Standard Operating Procedures (SOPs) as well as external regulations as determined by regulatory agencies.
• Supervise the activities of processing staff by directing workflow and reporting performance to direct supervisor or manager as necessary.
• Discuss/explain operational and procedural changes to Processing staff.
• Train staff on operational and procedural changes as needed.
• Delegate responsibility and guide coworkers in a professional manner.
• Perform repetitive tasks while maintaining attention to detail.
• Make independent decisions regarding sample nonconformities in accordance with SOPs and regulatory requirements.
• Generate service tickets nonconformance report and deviations to document and correct/prevent processing issues.
• Troubleshoot problems and help to develop improved procedures.
• Responsible for maintaining the quality system through root cause analysis and development of corrective actions for deviations and nonconformities.
• Audit verify and maintain accurate records for each sample.
• Maintain donor client and employee confidentiality.
• Perform the final review of processing records prior to document archival.
• Initiate and/or review document change orders.
• Review personnel training records to ensure that staff are current when necessary.
• Coordinate and/or facilitate the training certification and competency assessment of staff.
• Perform general lab cleaning and maintenance.
• Understand Job Hazard Analysis concerns at each workstation and communicate safety issues deviation from procedures and abnormalities to responsible parties (Management IT Safety Representative etc.).

Project Lead Specialization:

• Support Research and Development projects: Review trial and record R&D methods for transfer to production environment.
• Support IT Projects: Serve as a liaison between IT and Production to ensure proper installation and setup of equipment and computer systems.
• Drive/Lead laboratory Projects:
  • Represent Stem Cell Processing Departments as a Project Lead including Change Control presentation when necessary.
  • Serve as subject matter expert (SME) during audits and inspections as necessary.
  • Draft and review IQ/OQ/PQ protocols and summary reports.
  • Execute method qualifications/validations
  • Draft edit and review Standard Operating Procedures (SOPs) Work Instructions and Forms.
• Project Data Review:
  • Execute formal raw data review activities.
  • Utilize basic statistical tools to analyze data in relation to trend results.

Travel:

• N/A

Qualifications

Knowledge Skills and Abilities:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

Leadership Experience:

• Works independently with limited supervision.
• Experience in guiding or mentoring junior staff.
• Experience in leading crossdepartmental team projects and/or special duties.

Language/Communication Skills:

• Communicates internally and externally with some focus on external communication which may include complicated or sensitive information.
• Demonstrate ability to write routine reports and correspondence.
• Demonstrate ability to speak effectively before groups of employees in the organization. Use grammar vocabulary and style to communicate logically.
• Demonstrates social capability interacts confidently and reads the situation. Empathetic and can evaluate likely reactions.
• Communicate effectively with other departments regarding sample process flow issues system issues safety issues or general information.

Mathematical Skills:

• Ability to add subtract multiply and divide in all units of measure using whole numbers common fractions and decimals.
• Ability to compute rate ratio and percent and to draw and interpret bar graphs.

Reasoning Ability:

• Requires indepth analysis and conceptual thinking to problem solve.

Work Environment:

Schedule/ Work Hour Requirements:

• This is an onsite position in Tucson AZ
• Work hours dictated by the requirements of the lab; flexible to work alternate schedules able to work midshifts weekends and holidays.
• Flexible to accommodate scheduling gaps and staffing challenges.

Physical Requirements:

The requirements described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job the employee is regularly required to balance activities that require seeing listening touching and verbalizing needs.
• Specific vision abilities required by this job include close vision distance vision color vision and the ability to adjust focus.
• Perform repetitive tasks for prolonged periods.
• Frequently required to walk; climb ladder or step stool; sit and reach with hands and arms.
• Lift and/or move up to 50 pounds.
• Stoop kneel crouch or crawl.
• The employee is required to wear personal protective equipment whileprocessing potentially biohazardous products that may include umbilical cord blood blood products and/or umbilical cord tissue.
• The employee is required to wear personal protective equipment while utilizing cleaning reagents that may contain hazardous chemicals.
• The employee is required to wear personal protective equipment while utilizing liquid nitrogen and working with equipment that maintains extreme low temperatures.

Experience / Education:

• Bachelors or Associate degree in a Laboratory Science or MLT/CLT;
• and/or 7 years experience working at CBR
• and/or equivalent combination of education/experience.

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team.

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 viaemail 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.

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.