Stem Cell Processing Project Lead

About CooperSurgical

CooperSurgical is a leading fertility and women's 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 women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Job Summary:

Cord Blood Registry (Cbr) Stem Cell Processing Project Lead is 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, the Stem Cell Processing Project Lead performs focused baseline responsibilities in support of stem cell processing with an emphasis on key area(s) of specialization overseeing the design, implementation and delivery 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 co-workers in a professional manner.
• Perform repetitive tasks while maintaining attention to detail.
• Make independent decisions regarding sample non-conformities 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 non-conformities.
• 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 succe