Quality & Control Specialist

Gulf Coast Blood•Houston, TX

22h•Onsite

About The Position

Under supervision of the Quality Control Manager and Assistant Manager, QC Specialist prepares and tests samples from blood components to determine if the products meet established quality control standards. This position also works under the direction of the Technical Manager and Cellular Therapy Lab Specialist in performing all aspects of flow cytometry testing, as well as other testing related to the Advanced Therapies department and laboratory projects. Will lead or assist with projects and validations. Involves critical thinking skills, frequent contact with internal and external customers, good judgment, diplomacy and tact.

Requirements

Bachelor’s degree from an accredited college or university.
At least three years prior job-related experience or training, or an equivalent combination of education and experience.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedures.
Ability to communicate effectively with staff and clients
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute percentages and volumes.
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.
Must be flexible with working hours and days
Computer skills. Proficiency in Microsoft Office and Laboratory Information Systems
Organizational skills, attention to detail, quality, and accuracy
Ability to manage multiple projects and prioritize own work
Time management skills
Ability to work independently or collaboratively
Critical thinking skills
Regularly required to use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch or crawl and talk and hear.
Frequently required to stand and walk; occasionally required to sit, climb or balance.
Must frequently lift and/or move up to 25 lbs.
Employees are required to be familiar with and abide by the team lift requirements as specified in the Safety Program in an effort to prevent bodily injury and for the health and safety of others.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Nice To Haves

MT/MLS or BB (ASCP or equivalent) is preferred
Experience in a general laboratory setting, particularly in hematology, microbiology, and blood bank operations, is highly desirable.

Responsibilities

Perform all core duties of a QC Technician III at a high level of proficiency and technical expertise.
Communicate promptly and professionally with internal teams and external customers regarding positive bacterial culture results.
Initiate product recalls for units associated with positive bacterial findings in accordance with regulatory and organizational procedures.
Ensure all required follow-up testing for positive bacterial cultures is completed, thoroughly documented, and results are accurately communicated to external clients.
Review and ensure the completeness and accuracy of Quality Control (QC) documentation.
Track, trend, and analyze QC data for laboratory testing equipment to ensure ongoing compliance and performance.
Assist with monitoring and trending departmental goals and production metrics.
Oversee daily QC Laboratory operations in the absence of supervisory staff to ensure continuity and efficiency.
Promptly communicate workflow, process, or staffing issues to the Manager or Assistant Manager that may impact timely product or result release or affect the work environment.
Monitor staff workload and prioritize tasks to optimize laboratory efficiency and resource utilization.
Proactively assess operational processes to identify opportunities for improvement, ensuring adherence to Standard Operating Procedures (SOPs) and compliance with OSHA, FDA, AABB, cGMPs, and other applicable regulatory requirements.
Serve as a lead for new hire onboarding and ongoing staff training, providing guidance, support, and mentorship.
Conduct and document staff competency assessments in accordance with regulatory and organizational requirements.
Assist with or lead departmental and organizational projects, including validation activities and process improvements.