Quality Systems Associate
1 month ago
table.MiTabla { max-width: 1020px;important
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Quality Systems Associate
Summary:
Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.
Primary responsibilities for role (level-specific responsibilities should be included in the chart below):
● Completes weekly review of equipment QC and maintenance records.
● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
● Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
● Performs documentation review for unsuitable test results.
● Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include:
Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.
● Performs all product release activities.
● Reviews lookback information and documentation.
● Reviews waste shipment documentation.
● Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
● Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
● Reviews donor deferral notifications from competitor centers.
● Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
Quality Systems Associate
● Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include:
● Creates, maintains, and audits training records and files to ensure compliance.
● Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
● Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
● On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
● Reviews and approves of deferred donor reinstatement activities.
● Assists with completion of the internal donor center audit.
Summary:
● Performs review of monthly trending report.
● Performs review of donor adverse events reports and the applicable related documentation.
● Conducts training to address donor center corrective and preventative measures.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Additional Responsibilities:
Is certified and maintains certification as a Donor Center Technician.
Knowledge, Skills, and Abilities:
Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols. Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail.
Education:
High school diploma or GED. Obtains state licensures or certifications if applicable.
Experience:
Typically requires no previous related experience.
Occupational Demands:
Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.
CLK789
#Biomatusa
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws
Location: NORTH AMERICA : USA : VA-Norfolk:USNOR - Norfolk VA-N Military Hwy-BIO
Learn more about Grifols
-
Quality Assurance Engineer
1 week ago
Norfolk, Virginia, United States Sunrise Systems Full time**Job Title:** Test Analyst**Location:** Remote**Duration:** 4 months contract with possible extension**Job Description:**Our client, a leading healthcare provider in the United States, is seeking a talented and creative Test Analyst to join their team at Sunrise Systems. This is an excellent opportunity to work in a growing environment and contribute to the...
-
Sprinkler System Specialist
21 hours ago
Norfolk, Virginia, United States Cynet Systems Full timeJob Title: Sprinkler Inspector Job Summary: We are seeking a highly skilled Sprinkler Inspector to join our team at Cynet Systems. As a Sprinkler Inspector, you will be responsible for performing routine inspections, testing, servicing, installing, and preventative maintenance of life safety product lines. You will work with low voltage wiring and...
-
Norfolk, United States EPSILON SYSTEMS Full timeEpsilon Systems Solutions, Inc. has an opportunity for a full-time Quality Assurance and Non-Destructive Test Specialist in Virginia Beach, VA.Summary: The Quality Assurance and Non-Destructive Test Specialist will provide Quality Assurance (QA) and Non-Destructive Testing (NDT) to command forces for testing, inspection and certification of minor and major...
-
Quality Assurance Specialist for Naval Systems
2 weeks ago
Norfolk, Virginia, United States M.C. Dean, Inc. Full timePosition Overview:As a Quality Assurance Specialist at M.C. Dean, Inc., you will play a critical role in ensuring the integrity and compliance of our naval systems. Your expertise will be essential in maintaining high standards of quality throughout the inspection process.Key Responsibilities:- Conduct thorough inspections on board naval vessels, adhering to...
-
Inertial Systems Engineer for Aircraft Alignment
2 weeks ago
Norfolk, Virginia, United States WR Systems Full timeAircraft Inertial Alignment System (AIAS) Engineer PositionCompany: WR SystemsClearance Requirement: Ability to obtain and maintain a Secret ClearanceTravel Requirements: Up to 25%Location: Norfolk, VASUMMARY: WR Systems is seeking a skilled Aircraft Inertial Alignment System (AIAS) Engineer to represent the Navigation Systems In-Service Engineering Activity...
-
Inertial Systems Engineer for Aircraft Alignment
2 weeks ago
Norfolk, Virginia, United States WR Systems Full timeOpportunity for Aircraft Inertial Alignment System (AIAS) EngineerCompany: WR SystemsClearance Requirement: Ability to obtain and maintain a Secret ClearanceTravel Requirements: Up to 25%Location: Norfolk, VASUMMARY: WR Systems is seeking a skilled Aircraft Inertial Alignment System (AIAS) Engineer to support the Navigation Systems In-Service Engineering...
-
Elevator Systems Specialist
12 hours ago
Norfolk, Virginia, United States Epsilon Systems Full timeJob SummaryEpsilon Systems Solutions, Inc. is seeking a skilled Electrical Elevator Support Technician to join our team in Newport News, VA.Key ResponsibilitiesProvide technical support and assistance on electrical systems and components, including U.S. Navy shipboard weapons elevators, cargo elevators, and dumbwaiters.Conduct research and provide technical...
-
Lead Field Representative
2 weeks ago
Norfolk, Virginia, United States W R Systems Full timeJob SummaryW R Systems is seeking a highly skilled and experienced Lead Field Representative to join our team. As a key member of our Navigation Systems team, you will be responsible for representing our company in the performance of Aircraft Inertial Alignment System (AIAS) repair, ILS support, and Field Change upgrades on US Navy Ships.Key...
-
Systems Architect
1 day ago
Norfolk, Virginia, United States W R Systems Full timeJob SummaryW R Systems is seeking a highly skilled Systems Engineer to join our team. As a Systems Engineer, you will be responsible for designing and developing system-level solutions, providing systems support, and collaborating with cross-functional teams to deliver high-quality results.Key ResponsibilitiesPerform initial system analysis, including scope...
-
Lead Field Representative
7 days ago
Norfolk, Virginia, United States W R Systems Full timeJob SummaryW R Systems is seeking a highly skilled and experienced Lead Field Representative to join our team. As a Lead Field Representative, you will be responsible for representing the Navigation Systems ISEA in the performance of Aircraft Inertial Alignment System (AIAS) repair, ILS support, and Field Change upgrades on US Navy Ships.Key...
-
Lead Field Representative
2 weeks ago
Norfolk, Virginia, United States W R Systems Full timeJob SummaryW R Systems is seeking a highly skilled and experienced Lead Field Representative to join our team. As a key member of our Navigation Systems ISEA team, you will be responsible for representing our company in the performance of Aircraft Inertial Alignment System (AIAS) repair, ILS support, and Field Change upgrades on US Navy Ships.Key...
-
Maintenance Mechanic
4 months ago
Norfolk, United States EPSILON SYSTEMS Full timeEpsilon Systems Solutions Inc. is seeking a full time Maintenance Mechanic (Damage Control/Propulsion Systems Support) in Norfolk, VA. Job Summary: Provide Damage Control and Propulsion systems equipment & systems support for the Carrier Engineering Maintenance Assist Team (CEMAT). Responsible for working closely with CEMAT, Government, and ship's force...
-
Aluminum Structural Fitter
7 days ago
Norfolk, Virginia, United States Quality Support Services Full timeJob SummaryWe are seeking a highly skilled Aluminum Structural Fitter to join our team at Quality Support Services. As a key member of our fabrication team, you will be responsible for working with a team of Pipe Fitters and welders to achieve maximum production in minimum time, while maintaining high standards of quality and safety.Key...
-
Software System Tester
3 weeks ago
Norfolk, VA, United States Imagine One Technology Full timeImagine One is currently seeking a Software System Tester to support the US Navy to assist in the design and execution of test plans in support of user requirements for moderately complex to complex software/hardware applications. Support will be required in the following areas: Testing applications and interfaces, Product Interval (PI) planning,...
-
Cybersecurity Systems Analyst
2 weeks ago
Norfolk, Virginia, United States Naval Facilities Engineering Systems Command (NAVFAC) Full timePosition Title: IT Specialist (PLYCPLN/INFOSEC), GSSalary Range: $104,861 - $136,323 annuallyEmployment Type: Full-TimeJob Classification: PermanentService Category: CompetitiveWork Location: Naval Facilities Engineering Command, ATLANTICKey Responsibilities:Evaluate the vulnerabilities of existing information systems to establish a comprehensive risk...
-
Senior Systems Engineer for Medical Applications
2 weeks ago
Dahlgren, VA, United States WR Systems Full timeClearance Requirement: A current Active Secret Clearance is essential for this position.Travel Expectations: WR Systems is seeking a Senior Systems Engineer to conduct independent evaluations of hardware and software interactions, identifying alternatives to enhance the efficiency of computing resources and advanced hardware solutions.The role...
-
Parts and Sales Associate
2 weeks ago
Norfolk, United States ATLANTIC LIFT SYSTEMS INC Full timeJob DescriptionJob DescriptionDescription:Job SummaryWe are looking for a proactive and detail-oriented Parts and Sales Associate to join our team. This role is crucial in maintaining the efficiency of our parts department and supporting the sales of service and parts for customer-owned equipment. The ideal candidate will be highly organized, passionate...
-
Quality Inspector
2 weeks ago
Norfolk, United States Bauer Compressors Full timeThe Quality Inspector performs quality assurance procedures and is responsible for providing technical assistance and support to the Quality and Assembly Departments to increase efficiency and throughout the production areas. JOB FUNCTIONS Include the following, but other duties may be assigned. Inputs, updates, and maintains quality assurance data in the...
-
Senior Quality Assurance Manager
3 days ago
Norfolk, Nebraska, United States Brightpath Associates LLC Full timeJob DescriptionBrightpath Associates LLC is seeking a highly skilled and experienced Senior Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the overall quality and safety of our products.Key Responsibilities:Develop and implement a preventative quality system to ensure compliance with...
-
Sprinkler System Inspector
1 day ago
Norfolk, Virginia, United States Axelon Full timeJob Title: Sprinkler Inspector **Job Summary:** We are seeking a skilled Sprinkler Inspector to join our team at Axelon. As a Sprinkler Inspector, you will be responsible for performing quality inspections, testing, servicing, installing, and preventative maintenance of life safety product lines. **Responsibilities:** * Perform routine inspections,...