Laboratory Services Specialist (Durham, NC)

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:

This position is a full-time on-site position who will work to achieve operational targets within the lab for the Durham NC Laboratory for California Cryobank with direct impact on department results. This role will influence parties within and outside of the technical function at an operational level regarding policies procedures and practices. Will also assist leadership with responsibilities including assisting with interviewing and training employees in the Laboratory. This role will be responsible for collaborating with management with planning assigning and directing laboratory work evaluating laboratory performance addressing complaints and resolving problems in a timely manner. This position primarily works within the laboratory leading the day-to-day tasks involved with operating a reproductive tissue laboratory. It is the Laboratory Services Specialists job to ensure the assigned location complies with all regulatory quality assurance quality control standard operating and safety procedures. It is essential that this position oversees and coordinates all laboratory activities at the assigned location ensuring that operations are compliant with company Standard Operating Procedures policies and regulatory requirements are always met. Specific functions listed below.

• Essential Functions & Accountabilities:
  Maintains demonstrated proficiency with all applicable Standard Operating Procedures.
• Complies with all regulatory quality assurance quality control standard operating and safety procedures.
• Oversees and coordinates all laboratory activities at the branch ensuring that operations are compliant with company Standard Operating Procedures.
• Trains and re-trains all technical employees; keeps staff training documents up to date.
• Acts as a point-of contact and as a liaison between leadership laboratory and office staff in the absence of Lab Management.
• Assists with operational projects related to laboratory and local branch functions.
• Semen Specimen Processing:
  Maintains demonstrated proficiency in specimen processing.
• Performs complete qualitative and quantitative sperm evaluation.
• Performs IUI and ICI (if applicable) processing by employing appropriate means of each specimen.
• Performs post-thaw analysis.
• Assesses sperm morphology using WHO criteria.
• Makes processing recommendations to the lab reviews semen processing and consults with donors and leadership as needed.
• Assists and leads decision making points during semen specimen processing.
• Blood/Urine Specimen Procurement/Processing:
  Performs phlebotomy (if licensed or certified).
• Processes and prepares blood and urine specimens for transport to the reference laboratory.
• Reports positive results to the Donor and CCB management.
• Reviews reference lab testing and follows up on positive results or discrepancies.
• Cryogenic Functions:
  Performs routine cryogenic procedures including vial transfers; daily quality controls/tank checks.
• Performs vial QC by verifying vial labels and number/type of vials.
• Oversees vial inventory management; transfers vials as required by Standard Operating Procedures and as requested by Biorepository Department.

Operational Functions:

• Reviews and signs off on monthly QC records; ensures that routine maintenance of laboratory equipment is performed at defined intervals; initiates problem logs for any equipment or process issues; takes corrective action as needed.
• Liaison between local site and Medical Director for laboratory related activities.
• Reviews and signs off on potential donor specimen evaluations.
• Reviews of donor processing data (worksheets and manifests) and Navision worksheet entries prior to transfer to long term storage.
• Hosts and records lab meetings. Trains staff on all changes as required.
• Participates in the review of Standard Operating Procedures; contributes to standard operating procedure modifications.
• Ensures proper and timely maintenance of laboratory and biorepository equipment supplies and monitoring systems; provides technical support as needed.
• Ensures that donor blood draws are done within the Branch or at remote locations if necessary according to Standard Operating Procedures and in a timely fashion.
• Maintains an efficient operation by ensuring that adequate supplies are stocked and that inventory is appropriately maintained as specified by the manufacturer and Standard Operating Procedures.
• Quality Functions:
  Participates in and executes laboratory staff competency assessments.
• Documents and communicates errors accidents or incidents to responsible leadership.
• Reviews laboratory quality control reports deviations and nonconformances in a timely manner. Recommends and establishes corrective actions as needed.

Travel:
Travel as needed totaling <10%

Qualifications:

Knowledge Skills and Abilities:

• Ability to speak and write in English; communicate effectively and professionally with clients and external contacts;maintain interpersonal skills to interact with laboratory team peers and management; read and interpret documents such as procedure manuals; write reports and business correspondence; respond to common inquiries or complaints from clients and regulatory agencies; maintain confidentiality; handle multiple tasks simultaneously; maintain excellent organizational skills; and effectively present information and respond to questions from management the Board of Directors clients and the general public.
• Ability to add subtract multiply and divide in all units of measure using whole numbers common fractions and decimals and to compute rate ratio and percentage. Ability to define problems collect data establish factors and draw valid conclusions; interpret an extensive variety of instructions; and work with several abstract and concrete variables.
• Phase-contrast microscopy skills; knowledge of and proficiency in MS Word and Excel; phlebotomy experience desired not required; familiarity with laboratory and medical terminology; training in the handling of liquid nitrogen.
• Ability to lift to 35 lbs. required.

Work Environment:

• 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

Experience:

• Requires advanced knowledge of laboratory operations typically obtained through advanced technical education combined with experience.

Education:

• Bachelors degree in a related field such as life sciences and 6 years experience; and/or equivalent combination of education and 8 -10 years experience.
• Phlebotomy license and/or certification based on state regulations desired but not required.

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.