Quality Assurance(QA) Specialist - Hornet Staffing, Inc. - Morrisville, NC, US | Dice.com

Hornet Staffing, Inc.

Apply Now

Quality Assurance(QA) Specialist

Morrisville, NC, US • Posted 1 day ago • Updated 1 day ago

Contract W2

On-site

$35 - $38/hr

Apply Now

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Fitment

Dice Job Match Score™

✨ Finding the perfect fit...

Job Details

Skills

Analytical Skill
GMP
Good Manufacturing Practice
Inspection
Manufacturing
Manufacturing Engineering
Pharmaceutics
Pharmaceutical Industry
Regulatory Compliance
Research and Development
Quality Management
SAP
Science
Storage
Testing
Training
Veeva
Quality Assurance

Summary

Description:

Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence.
Responsible for performing inspection and disposition of raw materials and components by:
- Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
- Obtaining Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.
- Reviewing and verifying all incoming documentation to confirm that materials meet defined testing specifications and quality standards.
- Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.
- Archiving finalized Master Specifications and associated release documentation in the document control room, maintaining accurate and organized records.
Proactively assess potential risks and implement mitigation strategies, ensuring timely communication with relevant stakeholders.
Complete assigned training and tasks within required timelines, represent the Quality function in cross-functional meetings, and provide feedback to the team as needed.
Provide quality oversight and compliance guidance in accordance with company procedures and standards outlined in the SMPA Quality Management System.
Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.
Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner.
This role is an on-site position, scheduled Monday through Friday, primarily supporting GMP operations. The standard working hours are from 8:00 AM to 4:00 PM; however, flexibility may be required based on business needs.

Qualifications :

S. in chemistry, biological or pharmaceutical sciences, or related discipline
At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.
Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs.
Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.
Working experience in KNEAT, SlingShot, SAP, Blue Mountain RAM and VEEVA is preferred.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91094220
Position Id: 8828166
Posted 1 day ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Richmond, Virginia

•

Today

Title: DMV Data Quality Specialist Lead, Position No. 00318 State Role Title:Admin and Office Spec Hiring Range: $47,070.00 - $54,130.50 Pay Band: 3 Agency: Department of Motor Vehicles Location:REPORT EVALUATION Agency Website:;br> Recruitment Type: General Public - G Job Duties The Virginia Department of Motor Vehicles (DMV) is looking to hire a Data Quality Specialist Lead! The Data Quality Specialist Lead ensures the accurate maintenance and reporting of crash data within the Traffic Reco

Full-time

USD 47,070.00 - 54,130.50 per year

Systems Engineer

Morrisville, North Carolina

•

9d ago

Kelaca is seeking an IT/OT Systems Engineer for our Client Partner in Morrisville, NC, a growing gene therapy organization operating in FDA/GMP-regulated manufacturing environments. This role is ideal for a technical leader who thrives at the intersection of enterprise IT infrastructure, operational technology, and regulated biotechnology operations. The IT/OT Systems Engineer plays a pivotal role in designing, optimizing, implementing, and maintaining the infrastructure that supports both corp

Easy Apply

Contract

45 - 55

Hiring - Senior Principal Systems Engineer (Software) Medical Device - Onsite

Raleigh, North Carolina

•

Today

Job Description Senior Principal Systems Engineer (Software) Infusion Pump Platforms Overview This role focuses on developing and sustaining software for Infusion Pump medical devices, delivering high-quality healthcare solutions that meet regulatory standards. You will lead system-level software engineering activities, guide cross-functional teams, and ensure compliance with medical device development processes. Key Responsibilities Lead best practices for software systems development and li

Easy Apply

Third Party, Contract

Validation Engineer III

Remote or Durham, North Carolina

•

Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

Quality Assurance(QA) Specialist

Dice Job Match Score™

Dice Job Match Score™

Job Details

Skills

Summary

Similar Jobs

Dice Job Match Score™

Anuj Mehandru