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Quality Assurance Coordinator

Location: 

MD-Baltimore, US

Contract Type:  Regular Full-Time
Area:  Nursing/Healthcare
Req Id:  137587

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.

SUMMARY:
This position is responsible for performing quality assurance activities in the automated Source Plasma
center as defined in Standard Operating Procedures including, but not limited to, donor safety, product
safety, and equipment. Other routine activities include 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.


ESSENTIAL JOB FUNCTIONS:
Daily:
• Runs eProgesa reports as necessary and takes the appropriate action based on report information.
• Reviews the following eProgesa donor records for each occurrence:
• Body Map
• Informed Consent
• Informed Consent – Pre-existing antibodies
• Donor Checks
• STS/SPE/ATYA Results
• Completed Donor Adverse Event
• Completed Cohabitation Questionnaire
• Smallpox Vaccination Evaluation
• SARS Evaluation
• Reviews all daily, weekly, monthly, semi-annual, annual and biennial quality records for compliance and
actions taken. Verifies proper storage for record integrity.
• Must maintain certifications in all production job descriptions.
• Performs all job duties in a safe manner and uses required personal protective equipment.
• Reviews reports for deferred donors and unsuitable units.
• Performs quality review of Error and Accident Reports, Customer Complaints and Donor Complaints.
• Reviews sample and product shipments and associated paperwork, including direct observation of the
sample and product shipment packing process.
• Verifies product shipments for release, including the removal of any units initially packed for shipment
that become unsuitable for the customer.
• Verifies Lookbacks, including removing any units from customer inventories and placing into locked
quarantine storage.
• Monitors employee and facility activities for compliance with procedures.
• Reports non-compliances or any quality concerns to the Center Manager, Regional QA Manager,
Regional Operations Manager and Corporate Quality Assurance.
Interacts internally with center IBBI personnel and with donors.
• Follows all Standard Operating Procedures (SOPs) and Company policies.
Frequent:
• Reviews Pending Unit Disposition Report and any other information as necessary, to verify that
unsuitable product (if any) is quarantined and not released for shipment.
• Performs quality review of Validations, Qualifications, Calibrations (including externally calibrated
equipment certificates) and Maintenance Records.
• Provides quality-focused assistance to all areas of the facility; contacts Corporate Quality Assurance
to assist in resolving questions.
• Emphasizes continual quality improvement by assisting in corrective and preventive action, including
follow-up effectivity evaluation.
• Performs internal audits as specified in the IBBI procedures.
• 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 other duties as required or assigned.
Infrequent:
• May monitor and review employee training files.
• Participates in Quality Assurance conference calls.
• Initiates, records, and acts on any necessary decisions made during the monthly CLIA Laboratory
Director’s Meeting.
• Initiates Document Change Requests and Variance Requests, when appropriate.
• Develops confidence and skills to host an external audit.


QUALIFICATIONS/EXPERIENCE:
• Bachelor’s Degree or equivalent work-related experience and/or training
• Bachelor’s degree in business administration or the biological sciences preferred
• Must have excellent interpersonal and communication skills
• Must have excellent problem-solving skills 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; and demonstrate tenacity
• 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
• Must have ability to establish and maintain effective working relationships within The Interstate
Companies and provide excellent customer service
• Experience in an FDA-regulated industry, preferred
• Knowledge of Good Manufacturing Practices, Safe Operating Procedures, Safety Data Sheets and
Biohazardous Waste
• Quality Assurance background, preferred
• 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 Ships samples, final packing of product, loads unit shipments onto
truck
Climbing Removes supplies from shelves
Bending/Stooping/Lifting Reviews sample shipment packing, supervises unit shipment,
reviews of incoming softgoods / supplies
Standing Reviews sample shipment packing, supervises unit shipment,
Center level audits
Sitting Reviews ePro reports, processes test results, reviews equipment
records
Hand/Wrist Use Reviews ePro reports, processes test results, reviews equipment
records
Observing/Seeing color Reviews ePro record files, reviews softgood tags
Hearing/Listening Center activity, hears alarms, hears fans running in storage units,
hears timing devices
Talking/Communicating Final verification of units or samples, trains employees, explains
corrections needed
Time Management Keeps the QA task flow consistent, manages the amount of time
needed for tasks, reviews records within the specified time frame
Focusing Concentrates on the task at hand, minimizes distractions
Reading SOPs, instructions, forms, reports, graphs, labels, body maps,
Company policies
Withstand Cold Ships samples, final packing of product, loads unit shipments onto
truck
• 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 use a spreadsheet.
• 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 responsibilities
to this job at any time.

 

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Location: NORTH AMERICA : USA : MD-Baltimore:IBBALTIM - Baltimore 

 

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