Laboratory Services Quality Technician I

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. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at .

Job Summary:

Quality Control Lab Technician I role at Cord Blood Registry (CBR) 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 clients final product. This position is also responsible for providing our internal customers with technical expertise while maintaining the highest quality services possible. The Quality Control Lab Technician I directly supports manufacturing to ensure the Product Operations function is provided with adequate equipment and materials to support stem cell processing activities. At the Technician I level the individual performs critical daily activities involving high complexity testing equipment maintenance and troubleshooting interfacing with service providers reagent testing executing quality control assays and environmental monitoring activities. The role is also involved with supporting and executing validations verifications and projects within the Quality Control department.

Essential Duties and 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
• Work in a biosafety level 2 (BSL-2) work environment
• Complete and maintain records that meet regulatory requirements
• Follow the laboratorys established policies and procedures whenever test systems are not within the laboratorys established acceptable levels of performance
• Follow the laboratorys 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 the CBR stability 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 participate in competency assessments
• Perform equipment calibration preventive maintenance and repairs
• 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
• Make informed and timely decisions independently
• 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

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Language Skills:

• Ability to read and interpret documents such as safety rules operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization.

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:

• Ability to apply common sense understanding to carry out instructions furnished in written oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills:

• Requires complete and broad knowledge of operating systems techniques and practices typically learned through extensive experience and/or education. Must be proficient in Microsoft applications: Excel Word Outlook.

Physical Demands:

• The physical demands described here 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 stand; use hands to finger handle or feel and talk or hear. The employee is frequently required to walk; sit and reach with hands and arms. The employee is occasionally required to stoop and kneel. 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 and ability to adjust focus.

Teamwork:

• Leads by example to maintain positive attitude and collegial work environment. Provides and is receptive to constructive feedback. Assist other team members as needed to accomplish the days or department tasks.

Work Environment:

Schedule/Work Hour Requirement:

• This is an onsite position in Tucson AZ
• Work hours are dictated by the requirements of the business. As business needs dictate works extended hours to complete daily department goals or tasks to include mandatory overtime. Able to work mid-shifts weekends and holidays. Required to be on-call periodically.

Exposure Risk:

• A requirement of this role is working with blood products and tissue. Safeguards are implemented for employees to protect them from exposure to blood products and tissue.

Clinical Laboratory Improvement Amendments (CLIA) Responsibilities and Qualifications:

• This role requires to take on additional roles to perform High Complexity testing (example: Testing 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 education training and experience.

Experience:

• One year of lab experience is preferred.

Education:

• Bachelors degree in one of the biological chemical or physical sciences.
• Transcripts are required to be eligible for the position.

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 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 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.