Data Processor I - Quality Control (Non-CLIA

CooperSurgical, Inc.

Tucson, AZ

Purpose:

Cord Blood Registry (Cbr) Data Processor I- Quality Control (Non-CLIA) is responsible for maintaining, reviewing and storing Quality Control Records. The Data Processor will also execute analytical and processing equipment maintenance, repairs and calibrations, as well as the support of environmental monitoring, supporting sterility testing for processing reagents, assisting with the releasing raw materials, 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.

Duties & Responsibilities:

• 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, environmental monitoring software
• Complete and maintain records that meet regulatory requirements
• Review Quality records for accuracy and completion
• Scan and file Quality Records
• Enter, trend, and analyze raw data for Quality Records
• 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 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)
• Provide support during peer training
• Assist with lab investigations, deviations, corrective actions, procedure changes, method qualification planning, etc.
• Support Research and Development projects
• Support the everyday organization of the laboratory activities including area cleaning, maintenance and ordering of supplies
• Familiarity with basic statistical tools necessary to analyze data and produce reports.
• 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.
• Respond to environmental monitoring alarms
• 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 biorepository activities
• 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
• Support documentation generation and revisions (SOPs, work instructions, forms, protocols, reports, etc.)
• Follow the laboratory's procedures for specimen handling and processing, reagent preparation, test analyses
• Perform equipment calibration, preventive maintenance and repairs
• Work in a biosafety level-2 (BSL-2) work environment
• Capable of working with a moderate degree of supervision and organizing own time
• Support the Cbr compliance procedures and policies (ex.: training, incident reports, deviations, documentation)
• Handle Liquid Nitrogen (LN2) utilizing personal protective equipment and good safety practices.

Basic Qualifications:

• High School Diploma or equivalent with data record management experience.
• Creative and innovative approach to his or her work and will offering objective and data driven observations and recommendations.
• 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.

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 may rarely need to lift and/or move up to 50 pounds.
• On occasion, employee may rarely need to 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.

About CooperSurgical:

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.

Our Benefits:

As an employee of CooperSurgical, you'll 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 www.coopersurgical.com 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 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.

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.