Job Details

ID #4358794
Estado Maryland
Ciudad Baltimore
Full-time
Salario USD TBD TBD
Fuente Grifols Shared Services North America, Inc
Showed 2020-07-14
Fecha 2020-07-15
Fecha tope 2020-09-13
Categoría Etcétera
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Quality Assurance Coordinator

Maryland, Baltimore 00000 Baltimore USA

Vacancy caducado!

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 Plasmacenter as defined in Standard Operating Procedures including, but not limited to, donor safety, productsafety, and equipment. Other routine activities include reviewing records, monitoring employee practices,assessing processes for compliance to procedures, evaluating corrective and preventive action foreffectivity, and notifying management and Corporate Quality Assurance of quality concerns related topractices 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 DutiesReaching Ships samples, final packing of product, loads unit shipments ontotruckClimbing Removes supplies from shelvesBending/Stooping/Lifting Reviews sample shipment packing, supervises unit shipment,reviews of incoming softgoods / suppliesStanding Reviews sample shipment packing, supervises unit shipment,Center level auditsSitting Reviews ePro reports, processes test results, reviews equipmentrecordsHand/Wrist Use Reviews ePro reports, processes test results, reviews equipmentrecordsObserving/Seeing color Reviews ePro record files, reviews softgood tagsHearing/Listening Center activity, hears alarms, hears fans running in storage units,hears timing devicesTalking/Communicating Final verification of units or samples, trains employees, explainscorrections neededTime Management Keeps the QA task flow consistent, manages the amount of timeneeded for tasks, reviews records within the specified time frameFocusing Concentrates on the task at hand, minimizes distractionsReading SOPs, instructions, forms, reports, graphs, labels, body maps,Company policiesWithstand Cold Ships samples, final packing of product, loads unit shipments ontotruck

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 responsibilitiesto this job at any time.EEO Minorities/Females/Disability/Veterans#biomatusaCLK 789Learn more about Grifols Req ID: 137587Type: Regular Full-TimeJob Category: Nursing/Healthcare

Vacancy caducado!

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