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DivIHN

QA Contractor, GMP Quality Assurance

NC · On-site

QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... Support regulatory (FDA, EMA) and internal audits/inspections per client procedures and applicable ...

Infojini Inc

Quality Manager

Saint Paul, MN · On-site

The QA Contractor's role in the project is to provide project monitoring, independent review, and technical support services to MN WIC during the e-WIC implementation phase of the project. The QA ...

The Atlantic

Manager, QA

Washington, DC

$145K - $165K/yr

Experience managing QA contractors, vendors, or offshore testing teams * Experience developing or significantly improving QA processes and standards within an engineering organization * Strong ...

HCL America Inc.

QA Analyst III

Menlo Park, CA · On-site

Menlo Park, California What You'll Do As a QA Contractor, you will play a key role in ensuring ... per year); and 10 paid holidays per year. How You ll Grow At HCLTech, we offer continuous ...

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Infographic showing various Per Diem Quality Assurance Contractor job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $47,496 per year, or $22.8 per hour.

QA Contractor, GMP Quality Assurance

DivIHN

NC • On-site

Contractor

Re-posted 4 days ago

Job description

For further inquiries regarding the following opportunity, please contact our Talent Specialist, Hema at (630) 847-0275
Title:QA Contractor, GMP Quality Assurance
Location: Onsite at Research Triangle Park, NC
Duration: 9 Months
Travel: Domestic travel (less than 10% of the time) expected.
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered
Description:
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of client Quality Management System (QMS) and will strongly support client's Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC.
Job Responsibilities
  • Manage assigned day-to-day QA responsibilities in support of the company's Quality Management Systems (QMS).
  • Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS based customer requests.
  • Liaison with applicable department record owners to ensure their complete and timely resolution. Review and Approve said record types as assigned.
  • Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.
  • Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines.
  • Providing deliverables and resolving issues; Draft SOPs/controlled documents as well as perform quality unit review and approval of Quality Management Systems requests/ records related to Learning Management, Non-Conformance Management, CAPA management, and metric/KPI reporting.
  • Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.
  • Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.
  • Perform daily customer-facing activities, as assigned by area management.
  • Maintain health of customer-facing activities such as document archival activities and notebook/logbook assignment and management.
  • Identify and collaborate with colleagues to implement continuous improvement initiatives; provide Quality Unit oversight of QMS based activities.
  • Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.
  • Support regulatory (FDA, EMA) and internal audits/inspections per client procedures and applicable regulatory requirements.
  • Communicate project status to stakeholders and escalate issues in a timely manner.
  • Perform and support other duties as assigned by area management.

About you
  • Bachelor's degree in a scientific field and 4+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 10+ years of GMP based Quality Assurance experience using a company QMS.
  • 3+ experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement
  • Strong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
  • Ability to author, review, and interpret Standard Operating Procedures (SOPs).
  • Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
  • Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
  • Strong service-oriented mindset with excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
  • Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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