Quality Assurance Specialist jobs in Greenville, SC

Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

K
Quality Assurance Specialist
  • . KEDPLASMA LLC.
  • Anderson, SC FULL_TIME
  • KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.

    Please be advised that our organization participates in
    E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.


    Kedrion
    Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including:

    • Medical, vision and dental insurance
    • Life and AD&D insurance
    • Paid holidays
    • PTO accrual
    • and much more!

    Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!


    Please note that salary ranges are calculated based off levels
    of: relevant experience, education and certifications.


    Duties and Responsibilities:
    1. Ensure general understanding of all applicable state, federal regulations, industry and corporate policies.
    2. Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP’s (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
    3. Ensure plasma release and shipments meet specifications and requirements as defined by customers and in DCOPs. When necessary, should have the authority to stop production and/or release of product.
    4. Review and investigate final shipment release deviations including accurate labeling and documentation of shipments.
    5. Determining that DCOP’s exist for all manufacturing procedures including, but not limited to, testing, and that DCOPs accurately describe and define the procedure, including a statement of what the procedure is intended to accomplish.
    6. Participate in review of Donor Center Operating Procedures (DCOPs) and validating processes.
    7. Review quality issues with QAM and Center Manager periodically and as needed.
    8. Review compliance issues with appropriate staff and their supervisions.
    9. Provide accurate reports of the facility’s compliance to QAM, Regional Manager and/or VP of QA/RA.
    10. Investigate, track/trend and follow up on corrective actions and preventative measures for center non-conformances and E&A, as well as provide analysis of preventive action on all incidents/errors as required.
    11. Participate in comprehensive internal and external audits of the facility
    12. Ensure correct documentation and computer use and archiving or backup including donor files.
    13. Ensure that supplies and equipment are received, maintained, stored and documented to meet quality regulations.
    14. Review qualification, calibration and maintenance, repair and operation of equipment and documentation of use.
    15. Ensure QC checks are performed on all units and cases of products stored and shipped by the center.
    16. Ensure QC checks are performed as required and in acceptable ranges for controls and test reagents.
    17. Encourage and participate in continuous quality improvement process.
    18. Monitor, prepare and submit epidemiological data for PPTA or in corporate required format(s).
    19. Ensure that all staff is trained and maintain their competency to perform all assigned tasks; Helps QAM to evaluate the following: a. Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance;
    b. Monitoring the recording and reporting of test results by reviewing work sheets, quality control records ,preventive maintenance records, and other records and entries (both manual and automated);
    c. Written tests to assess problem solving skills, knowledge of DCOPs, and theory; and
    d. Assessment of performance using internal blind specimens and external proficiency test specimens.
    Minimum acceptable scores, performance, and remedial measures to correct inadequate performance on competency evaluations should be documented and retained in personnel records. Evaluation summaries provide useful information to correct individual or group performance problems.
    20. Ensure that CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.

    JOB SPECIFICATIONS:
    1. Bachelor’s degree in science or minimum of 2 years plasma center experience required. Previous work experience demonstrating decision making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service.
    2. Excellent communication skills and ability to conduct oral presentations.
    3. Excellent people skills which extends to a diverse group of individuals and demographics.
    4. Three to five years of working experience in a biomedical field preferred.
    5. Ability to speak read and write in English. Professional appearance and demeanor.
    6. Ability to operate computer software including DMS (with training), eQue and Microsoft Office.

    PHYSICAL REQUIREMENTS:
    1. Ability to sit or stand for extended periods of time.
    2. Ability to tug, lift, and pull up to fifty (50) pounds.
    3. Be able to bend, stoop or kneel and climb stairs and/or ladder.
    4. Occupational exposure to blood-borne pathogens.
    5. Able to travel by plane and drive car.
    6. While performing the duties of this job, the employee is regularly required to stand; use hands to handle or feel objects, tools or controls.
  • 3 Days Ago

R
Quality Assurance Specialist
  • Recovery Centers of America
  • Greenville, SC FULL_TIME
  • Position Overview: Under the supervision of the Chief Executive Officer, the Quality Insurance/Performance Improvement Specialist will support company-wide initiatives to maintain the highest standard...
  • 12 Days Ago

F
Quality Assurance Trainer
  • First Quality Tissue, SE, LLC
  • Anderson, SC FULL_TIME
  • We are seeking a Quality Assurance Trainer for our First Quality Tissue facility located in Anderson, SC. Quality Assurance Trainers will train all new Quality team members and persons advancing to th...
  • 29 Days Ago

E
Quality Assurance Supervisor
  • EPC POWER CORP.
  • Simpsonville, SC FULL_TIME
  • DescriptionFounded in 2010, EPC Power is headquartered in San Diego County, California and has become the premier utility-scale inverter manufacturer in North America. The company continues to expand ...
  • 18 Days Ago

E
Quality Assurance Manager
  • Engineered Products
  • Greenville, SC FULL_TIME
  • ABOUT ENGINEERED PRODUCTS At Engineered Products, our mission is to maximize space efficiency and redefine material handling and storage solutions. With over 50 years of industry experience, we have e...
  • 18 Days Ago

R
Quality Assurance Analyst - Healthcare
  • Raag Solutions
  • clemson, SC FULL_TIME
  • THIS POSITION WILL PERFORM QUALITY ASSURANCE (QA) REQUIREMENTS AND SUPPORT USER ACCEPTANCE (UA) TESTING OF SOFTWARE CODING CHANGES TO MEDICAID SYSTEMS RELATED DATA. TESTING OF CHANGES WILL INCLUDE TES...
  • 19 Days Ago

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0 Quality Assurance Specialist jobs found in Greenville, SC area

V
Quality Control Auditor
  • Vision
  • Greenville, SC
  • Company Overview At Amsive, our people are our first priority. We’re a full-service performance marketing agency offerin...
  • 4/25/2024 12:00:00 AM

D
Quality Control Expert
  • DIRECT STAFFING LLC
  • Greer, SC
  • Job Description Job Description In the Quality Control Inspector Lead role, you will be responsible for supporting the Q...
  • 4/25/2024 12:00:00 AM

S
Quality Assurance Engineer
  • Spero Technology
  • Greenville, SC
  • What You'll Do You will be part of the Regulatory Systems team, comprising of Diverse group of developers, designers and...
  • 4/24/2024 12:00:00 AM

A
Quality Control Auditor
  • Amsive Llc
  • Greenville, SC
  • Company OverviewAt Amsive, our people are our first priority. Were a full-service performance marketing agency offering ...
  • 4/24/2024 12:00:00 AM

E
Quality Assurance Supervisor
  • EPC Power Corp
  • Greenville, SC
  • Quality Assurance Supervisor Founded in 2010, EPC Power is headquartered in San Diego County, California and has become ...
  • 4/23/2024 12:00:00 AM

A
QUALITY ASSURANCE SPECIALIST (CH-47)
  • Army National Guard Units
  • Greenville, SC
  • Summary This is a National Guard Title 32 Excepted position for a QUALITY ASSURANCE SPECIALIST (CH-47), Position Descrip...
  • 4/23/2024 12:00:00 AM

A
Quality Control Auditor
  • Amsive
  • Greenville, SC
  • Company Overview At Amsive, our people are our first priority. We're a full-service performance marketing agency offerin...
  • 4/22/2024 12:00:00 AM

A
Quality Control Auditor
  • Amsive
  • Greenville, SC
  • Job Description Job Description Company OverviewAt Amsive, our people are our first priority. Were a full-service perfor...
  • 4/22/2024 12:00:00 AM

Greenville is located at 34°50′40″N 82°23′8″W / 34.84444°N 82.38556°W / 34.84444; -82.38556 (34.844313, −82.385428), roughly equidistant between Atlanta (145 miles [233 km] southwest), and Charlotte, North Carolina (100 miles [160 km] northeast). Columbia, the state capital, is 100 miles (160 km) to the southeast. Greenville is in the foothills of the Blue Ridge Mountains, a physiographic province of the larger Appalachian Mountains range, and includes many small hills. Sassafras Mountain, the highest point in South Carolina, is in northern Pickens County, less than 40 miles (64 km) northwe...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$57,123 to $72,320
Greenville, South Carolina area prices
were up 1.5% from a year ago

Quality Assurance Specialist in Mcallen, TX
Those interested in a Quality Assurance Specialist position should highlight in their resumes engineering experience, quality assurance knowledge, time management, and teamwork.
December 06, 2019
Quality Assurance Specialist in Lubbock, TX
When recruiting for a telemarketing quality assurance specialist, you’ll often find candidates weighted too far toward one skillset or the other, or even trying to transition from technology QA into telemarketing QA when they’re wholly different animals.
February 24, 2020
Quality Assurance Specialist in Wichita, KS
This is a great opportunity for someone who wants to be part of a growing business as a Quality Auditor and work in a great Technical team.
January 11, 2020