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Quality Assurance Coordinator

Location: 

TN-Nashville, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  137621

 

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.

JOB TITLE:  QUALITY ASSURANCE COORDINATOR

 

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 samples from shelves

Bending / Stooping / Lifting

Reviews sample shipment packing, supervises unit shipment, reviews of incoming soft goods / 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 soft good 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 sample periods.
  • Ability to apply common sense understanding to apply instructions given in written, oral, or diagram form.
  • Ability to deal with problems involving 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.

 

#BiomatUSA, #CB, #GrifolsJobs

 

GRIFOLS IS AN EQUAL OPPORTUNITY EMPLOYER:  Minorities / Female / Disability / Veterans

 

“We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.”

Location: NORTH AMERICA : USA : TN-Nashville : IBNASHVI - Nashville 

Address:  3201 Gallatin Pike, Nashville, TN 37216  

Contact:  Alex S. Contreras, HR Staffing Partner III - (323) 441-7952  acontreras@grifols.com

 

Learn more about Grifols

  

To find more jobs with Grifols:  https://grifols.jobs