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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.SUMMARY:This position is responsible for performing quality assurance and training activities in the Whole Bloodcenter 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 QualityAssurance of quality concerns related to practices and/or product. This position is also responsible for thecoordination, implementation, and monitoring of all training initiatives for Whole Blood center personnel.ESSENTIAL JOB FUNCTIONS:Daily:Performs and/or coordinates all required employee training, per IBBI Policies and Procedures,
including, but not limited to:o Initial training for new employeeso On-going employee audits and assessmentso New or revised proceduresCollaborates 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) andMaintenance Records.Reviews sample and product shipments and all associated paperwork.
Reviews Center Physician records, frequency of visits, and verifies that any necessary actions have
been taken.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)
QUALIFICATIONS/EXPERIENCE: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 serviceAbility 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
Biohazardous WasteKnowledge and experience in training and adult learning theory
Quality Assurance background
Proficiency with computers
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVELTypical 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 DutiesReaching Trains on vitals, accesses supplies and softgoods on shelvesClimbing When needed to remove supplies from shelvesBending/Stooping/Lifting Receives softgoods/supplies, handles final packing of productStanding Conducts employee audits, trains employees, observes processesWalking Observes employeesHand/Wrist Use Documents training, grades assessments, performs audits, performstraining/duties in production areasObserving/Seeing color Reviews softgood tags, trains on donor card flags, trains onhemolyzed/lipemic units/samplesHearing/Listening Center activity, hears alarms, hears timing devicesTalking/Communicating Communicates with management, communicates with employees,trains employeesSitting Reads SOPs, prepares employee training files, prepares RADtraining, types, reviews recordsTime Management Keeps the QATC task flow consistent, manages the amount of timeneeded for tasks, meets deadlines for audits, assessments, andRADs within the specified time frameFocusing Concentrates on the task at hand, minimizes distractions, studiesnew processes, studies RAD changesReading 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, correspondenceAbility to read, analyze, and interpret general business periodicals, professional journals, technical
procedures, or governmental regulationsAbility 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 personnelAbility 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
form.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 responsibilitiesto this job at any time.EEO Minorities/Females/Disability/Veterans#biomatusaCLK 789Learn more about GrifolsReq ID: 154747Type: Regular Full-TimeJob Category: Nursing/Healthcare
Vacancy expired!