Top 34 Qa systems and documentation specialist Jobs in Durham Nc

QA Specialist (Hybrid)
Eisai —Raleigh, NC
- $66,200 - $86,800 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Continuous improvement
QA Area Specialist I - SDF (2nd shift)
Novo Nordisk —Durham, NC
- 6 years
- Computer literacy
- Mid-level
- Paid holidays
- Disability insurance
Complaint Reporting MDR/Vigilance Specialist 2
Teleflex —Morrisville, NC
- $73,000 a year
- Background check
- Nursing
- Microsoft Excel
- Paid parental leave
- Health savings account
Radiologic Technologist up to $10K Bonus
Concentra —Raleigh, NC
- Full-time
- CPR Certification
- Microsoft Excel
- Vital signs
- Commuter assistance
- Disability insurance
Specialist, Quality Assurance
FUJIFILM —Research Triangle Park, NC
- English
- 3 years
- Master's degree
- Wellness program
- Health savings account
Senior Specialist Quality Assurance, CSV
Definium Therapeutics —Durham, NC
- $101,147 - $122,757 a year
- Remote
- 7 years
- Psychiatry
- Bachelor's degree
- Health insurance
- Dental insurance
Quality Assurance Specialist
Science Corporation —Durham, NC
- Mid-level
- Continuous improvement
- Fair chance
11d
QA Manufacturing Specialist II (Nights)
KBI Biopharma —Durham, NC
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
Quality Specialist III
Precision Biosciences —Durham, NC
- 5 years
- Travel
- Senior level
QA Specialist, DSM Operations (Days 2-2-3 / 0600-1800)
FUJIFILM —Holly Springs, NC
- Call employer
- Bachelor of Science
- Mid-level
- Master's degree
2d
QA Specialist - Raw Materials
KBI Biopharma —Durham, NC
- Full-time
- Military encouraged
- Senior level
- Commercial
3d
Validation Project Lead / Documentation Audit Lead
FST Technical Services —Durham, NC
- Full-time
- Management
- Construction site
- Engineering
2d
Senior Manager, Learning Management System (LMS) - HR Technology
Labcorp —Durham, NC
- Full-time
- Hybrid work
- Office
- 3 years
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
Principal Specialist, ERP S4 HANA Project Management Test Lead (Remote)
RTX Corporate —Raleigh, NC
- $86,800 - $165,200 a year
- Full-time
- 3 years
- Bachelor's degree
- Travel
- Paid holidays
- Loan repayment program
7d
QA Specialist (QA Engineering)
InfoQuest Consulting Group Inc. —Holly Springs, NC
- Email
- Engineering
- Mid-level
- 3 years
EDI Specialist
Software Technology Inc —Raleigh, NC
- HIPAA
- Office
- Continuous improvement
Quick Apply
MANAGER, CODING OPERATIONS-Coding Integrity
Duke Health —Durham, NC
- 8 hour shift
- 6 years
- Bachelor of Science
- Finance
3d
Senior Specialist 2, QC LIMS
FUJIFILM —Holly Springs, NC
- Call employer
- Microsoft Outlook
- ERP systems
- Bachelor's degree
10d
Data Service Group Specialist - North Hills, NC
Advyzon —Raleigh, NC
- $60,000 - $70,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Mid-level
Quick Apply
11d
Digital Marketing Analyst, SEO & Web
MyEyeDr. —Raleigh, NC
- Full-time
- Hybrid work
- Marketing
- Office
- Analysis skills
- Paid holidays
- Health insurance

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QA Specialist (Hybrid)

Eisai -
Raleigh, NC

Apply Now

Job Details

Full-time
$66,200 - $86,800 a year

Qualifications

Content creation for technical audiences
Document control experience within pharmaceutical industry
Pharmaceutical regulatory compliance
SAP
Technical writing experience within manufacturing
Employee relationship building
GMP
Inventory management software
Manufacturing facility experience
Productivity software
Cross-functional collaboration
Cross-functional communication
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision. This role contributes to batch record review, documentation management, investigation support, and quality system activities to ensure compliance with cGMPs, internal procedures, and regulatory requirements. The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners while developing foundational QA knowledge and skills.

Essential Functions:

Responsible for document archival in Veeva Vault, ensuring accuracy, adherence to documentation standards, and preservation of full traceability, integrity, and completeness.
Assist in the development, implementation, and maintenance of quality procedures and policies to ensure adherence to company guidelines.
Maintain quality documentation and records in electronic systems in accordance with established procedures.
Review manufacturing batch records for completeness, accuracy, and compliance with procedures to support product disposition.
Support release activities by coordinating documentation readiness and collaborating with QA team members and cross-functional teams.
Support deviation, complaint, and investigation activities by gathering data, documenting findings, and tracking actions under supervision.
Collaborate with Eisai Network partners and Business Partners to respond to all quality inquiries and deliverables.
Participate in audits and inspections in a supporting role, such as document retrieval and response preparation.
Conduct ongoing tracking, documentation, and reporting of quality goals and metrics of own area of quality.
Contribute to continuous improvement initiatives and support efficiency within Quality processes.

Requirements:
Education:

Bachelor’s degree in a relevant scientific field with 2+ years of related in Quality Assurance in an FDA-regulated industry OR equivalent education and work experience.

Technical:

Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise)
Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable).
Knowledge and experience working with quality regulations to own area (e.g., experience working with regulated GMP systems and relevant health authorities).
Experience or familiarity with SAP inventory system.
Proficient in Microsoft Office tools.
Proven performance in earlier role.
Biologics experience preferred.

Must Possess:

Strong organization and communication skills and technical writing skills.
Strong attention to detail with the ability to follow procedures accurately.
Must be self-directed, goal-oriented, and quality conscious.
Demonstrates a strong learning mindset and receptiveness to feedback.
Exhibits professionalism, integrity, and accountability.
Builds effective working relationships with peers and cross functional partners.

Ability to work a hybrid schedule (a minimum of 3 designated onsite days - T, W, TH)
Values consistent with Eisai Values and ONE Team Behaviors together with an intrinsic understanding of Eisai’s hhc Mission and the need to always think first of the Patient.

Eisai Salary Transparency Language:

The annual base salary range for the QA Specialist (Hybrid) is from :$66,200-$86,800

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation

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Refine Your Search

qa systems and documentation specialist jobs in durham nc

QA Specialist (Hybrid)

QA Area Specialist I - SDF (2nd shift)

Complaint Reporting MDR/Vigilance Specialist 2

Radiologic Technologist up to $10K Bonus

Specialist, Quality Assurance

Senior Specialist Quality Assurance, CSV

Quality Assurance Specialist

QA Manufacturing Specialist II (Nights)

Quality Specialist III

QA Specialist, DSM Operations (Days 2-2-3 / 0600-1800)

QA Specialist - Raw Materials

Validation Project Lead / Documentation Audit Lead

Senior Manager, Learning Management System (LMS) - HR Technology

Principal Specialist, ERP S4 HANA Project Management Test Lead (Remote)

QA Specialist (QA Engineering)

EDI Specialist

MANAGER, CODING OPERATIONS-Coding Integrity

Senior Specialist 2, QC LIMS

Data Service Group Specialist - North Hills, NC

Digital Marketing Analyst, SEO & Web

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