Quality Control Technician

QC Technician II - Quality Control 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 client’s final product. This position is also responsible for providing our internal customers with technical expertise while maintaining the highest quality services possible.

Knowledge, Skills and Abilities:
Work Environment:
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 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, color vision and ability to adjust focus

**Experience**:

- 2-5 years in Quality Control or manufacturing laboratory environment
- Basic data analysis and report writing skills
- Knowledge of aseptic technique
- Ability to read, interpret and follow detailed procedures, instructions and drawings
- Solid understanding of QSRs/ISO
- Chemistry and laboratory skills, GLP/GMP experience
- Demonstrated team-oriented interaction skills/professional behavior
- Strong written and verbal communication skills
- Must know quality terms, definitions and concepts
- Must understand traceability (product, material, and calibration)
- Ability to discern product and process integrity to defined standards and methods, with the initiative to take appropriate action.

**Education**:

- Bachelor’s degree in one of the biological, chemical, or physical sciences with 3-5 years of applicable work experience OR
- Bachelor’s degree in a different science with a minimum of 5 years of relevant laboratory work experience.

Essential Functions & Accountabilities:

- Oversee all re-validation planning and scheduling (VMP) and manage all new validations related to QC or testing, such as temperature mapping and new instrument validations, and author VP/VR documents.
- Manage the entire EM program, including scheduling activities, sampling, administrative tasks, ordering consumables, tracking results, and addressing EM-related deviations. Coordinate consumable deliveries with Laboratory Services Specialist. Inspect materials promptly and release them for use by Production. Additionally, support daily organisation of Microbiology lab activities, including cleaning, maintenance, and supply ordering.
- Analyse and input EM results promptly. Respond to any excursions affecting production activities.
- Review tank readings monthly, track them over 12 months for trends indicating drift in usage or performance, and safely handle Liquid Nitrogen using appropriate protective equipment and safety protocols.
- Oversee the RCPA QAP program to ensure instruments meet specifications, manage CFU Assay QAP, and establish MSC QC QAP activity.
- Perform equipment IQ/OQ/PQ, calibration, preventive maintenance, and repairs.
- Assume responsibility for QC Lab management, including housekeeping. Become Subject Matter Expert (SME) for all instruments and train staff as Skills Assessor Trainer (SAT).

Adherence based Responsibilities:

- Prioritise and organise work to meet established schedules and deadlines and communicate effectively to foster cooperation and safety
- Provide audit preparation support activities
- Monitor and adhere to lab protocols when test systems fall outside accepted performance levels.
- Offer administrative support such as copying, filing, and archiving records and maintain donor, client, and employee confidentiality.
- Participate in training, projects, and housekeeping tasks
- Support Research and Development projects.
- Ensure adherence to lab procedures for specimen handling, processing, reagent preparation, test analyses, reporting, and record-keeping. Promptly notify management and initiate deviations as needed.
- Conduct data trending and utilise basic statistical tools for analysis.

Travel:
No travel, this role is