Grifols Shared Services North America, Inc Quality Assurance Training Coordinator - Interstate Blood Bank in Miami, Florida
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
This position is responsible for performing quality assurance and training activities in the Whole Blood
center as defined in Standard Operating Procedures. The responsibilities include, but are not limited to,
reviewing records, monitoring employee practices, assessing processes for compliance to procedures,
evaluating corrective and preventive action for effectivity, and notifying management and Corporate Quality
Assurance of quality concerns related to practices and/or product. This position is also responsible for the
coordination, implementation, and monitoring of all training initiatives for Whole Blood center personnel.
ESSENTIAL JOB FUNCTIONS:
- Performs and/or coordinates all required employee training, per IBBI Policies and Procedures,
including, but not limited to:
o Initial training for new employees
o On-going employee audits and assessments
o New or revised procedures
- Collaborates with management to implement and/or coordinate employee retraining and corrective
action, as necessary.
Maintains certifications in all productions areas.
Assesses the effectivity of training by monitoring employee compliance and performance.
Monitors, reviews, and maintains employee training files.
Selects and trains competent personnel to perform as training monitors.
Participates in Quality Assurance / Training conference calls as required.
Emphasizes continual quality improvement by assisting in corrective and preventive action, including,
follow-up effectivity evaluation.
- Provides quality-focused support and assistance to all areas of the facility; contacts Corporate Quality
Assurance to assist in resolving questions.
- Monitors the activities and practices of employees in the Center for compliance with IBBI Procedures
and Policies, including safety procedures.
- Reports non-compliances or any quality concerns to the Center Manager, Regional QA Manager,
Regional Operations Manager, and/or Corporate Quality Assurance, as appropriate.
Reviews various daily equipment check requirements for proper performance and recording.
Reviews the records of all donors for completeness and compliance to the procedural requirements;
including records signed by the Center Physician.
Reviews all test results and verifies that all unsuitable Donors are properly documented.
Reviews all quality records and donor records for compliance, permanent deferrals, center deferrals,
Adverse Reaction records, and corrective actions taken. Verifies proper storage for record integrity.
- Performs quality review of Error and Accident Reports, Customer Complaints, Donor Complaints,
Validations, Qualifications, Calibrations (including externally calibrated equipment certificates) and
Reviews sample and product shipments and all associated paperwork.
Reviews Center Physician records, frequency of visits, and verifies that any necessary actions have
Initiates Document Change Requests and Variance Requests, when appropriate.
Performs internal audits, as specified in the IBBI procedures.
Develops confidence and skills to host an external audit.
Monitors compliance with resolution of internal and external audit observations; collaborates with
management staff to prepare audit responses and coordinates any necessary follow-up actions.
Performs all Job Descriptions required/assigned.
Follows all Standard Operating Procedures (SOPs) and Company policies.
OTHER JOB DUTIES:
Performs other duties as may be required/assigned. (Frequently)
Interacts with donors, vendors, competitive centers, and auditors. (Frequently)
Bachelor’s Degree or equivalent work-related experience and/or training
Must have excellent interpersonal and communication skills
Must have above average problem-solving and decision-making abilities
Must be self-directed and highly-motivated
Explicit attention to detail is required
Must have excellent organization, analytical, and follow-up skills
Must have ability to establish and maintain effective working relationships within Interstate Blood Bank,
Inc. and provide excellent customer service
Ability to speak, answer questions, and/or present information in small groups
Ability to organize and prioritize work assignments
Ability to handle multiple priorities in a fast-paced environment
Ability to analyze situations and respond in a timely manner
Ability to participate in multi-functional teams
Experience in an FDA-regulated industry, preferred
Knowledge of Good Manufacturing Practices, Safe Operating Procedures, Safety Data Sheets and
Knowledge and experience in training and adult learning theory
Quality Assurance background
Proficiency with computers
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL
Typical work environment with moderate noise level
Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see, and hear for
extended periods of time, examples include:
Activity Typical Duties
Reaching Trains on vitals, accesses supplies and softgoods on shelves
Climbing When needed to remove supplies from shelves
Bending/Stooping/Lifting Receives softgoods/supplies, handles final packing of product
Standing Conducts employee audits, trains employees, observes processes
Walking Observes employees
Hand/Wrist Use Documents training, grades assessments, performs audits, performs
training/duties in production areas
Observing/Seeing color Reviews softgood tags, trains on donor card flags, trains on
Hearing/Listening Center activity, hears alarms, hears timing devices
Talking/Communicating Communicates with management, communicates with employees,
Sitting Reads SOPs, prepares employee training files, prepares RAD
training, types, reviews records
Time Management Keeps the QATC task flow consistent, manages the amount of time
needed for tasks, meets deadlines for audits, assessments, and
RADs within the specified time frame
Focusing Concentrates on the task at hand, minimizes distractions, studies
new processes, studies RAD changes
Reading SOPs, instructions, RADs, Variances, Company policies, etc.
Ability to work with toxic or caustic chemicals 25 - 50 % of the time.
Have exposure to outdoor weather conditions (shoveling or salting in the case of snowy weather).
Ability to read and understand documents, such as safety rules, operating and maintenance
instructions, procedure manuals, correspondence
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical
procedures, or governmental regulations
Ability to write reports, business correspondence, and procedural instructions
Ability to speak, answer questions, and/or present information in small groups
Ability to effectively present information and respond to questions from regional managers, employees,
suppliers, external customers, and Corporate personnel
- Ability to add, subtract, multiply and divide. Ability to perform mathematical operations using units of
US dollars, weight measurement, volume, and distance.
Ability to read a calendar, an analog clock, and use a calculator.
Ability to understand and calculate deferral periods and calculate sample periods.
Ability to apply common sense understanding to apply instructions given in written, oral, or diagram
Ability to deal with problems involving a multiple variables in complex situations.
Ability to lift up to 50 pounds
Travel is negligible
Daily attendance is required
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities
to this job at any time.
Learn more about Grifols
Req ID: 228007
Type: Regular Full-Time
Job Category: Nursing/Healthcare