Top 191 Regulatory documentation specialist i Jobs in Raleigh, Nc

QA Specialist (Hybrid)
Eisai —Raleigh, NC
- $66,200 - $86,800 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Continuous improvement
Regulatory Documentation Specialist I
Grifols —Clayton, NC
- Full-time
- Microsoft Excel
- Writing skills
- Office
Administrative Clinical Support Specialist I (Full Time, Remote, North Carolina Based)
Alliance Health —Morrisville, NC
- $20.73 - $26.43 an hour
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Disability insurance
- Health insurance
3d
Specialist, Risk and Compliance Services (Center of Excellence)
Deloitte —Raleigh, NC
- $63,000 - $116,000 a year
- Full-time
- Microsoft Outlook
- Research
- Mid-level
Applications Systems Specialist I – EHRA
State of North Carolina - DIT EBS —Wake County, NC
- $87,617 - $131,426 a year
- Full-time
- Hybrid work
- Computer Science
- High school
- System design
11d
Research Administration Program Specialist
North Carolina State University —Raleigh, NC
- $36,381 - $91,526 a year
- Full-time
- Mid-level
- Office
- University
- Paid holidays
- Disability insurance
4d
Environmental Specialist
Liberty Waste Solutions —Raleigh, NC
- Mid-level
- Bachelor's degree
- 1 year
Quick Apply
Leave Specialist - REMOTE
Ryder System —Raleigh, NC
- $55,000 a year
- Full-time
- Remote
- Microsoft Excel
- Mid-level
- Analysis skills
- Disability insurance
- Health insurance
Customer Care Advocate
MetLife —Cary, NC
- $41,600 a year
- Overtime
- High school diploma or GED
- Continuous improvement
- US work authorization
- Paid training
- Paid holidays
NCQA Quality & Accreditation Specialist (Full Time, Remote, North Carolina Based)
Alliance Health —Morrisville, NC
- $69,592 - $88,729 a year
- Full-time
- Remote
- Microsoft Word
- Nursing
- Microsoft Excel
- Disability insurance
- Health insurance
6d
FT Staff: Records Specialist-Transfer Credit
Shaw University —Raleigh, NC
- Extended hours
- Writing skills
- English
- Mid-level
Quick Apply
Jr. HSE Specialist - Grid Automation
Hitachi —Raleigh, NC
- Full-time
- Hybrid work
- Up to 50% travel
- Office
- Bachelor's degree
- AD&D insurance
- Disability insurance
Environmental Specialist
Circle K —Raleigh, NC
- Mid-level
- Negotiation
13d
Technical Document Specialist II - Sr. Technical Document Specialist
Grifols —Clayton, NC
- Full-time
- Bachelor of Science
- Mid-level
- Java
Food & Beverage Support Specialist
Golden Corral Corporation —Raleigh, NC
- Mid-level
- Ability to lift 50 pounds
- Bachelor's degree
10d
FSP Country Approval Specialist
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Computer literacy
- English
- Mid-level
Country Approval Specialist - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- English
- Mid-level
- Office
Principal Clinical Trial Coordinator - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Office
- Bachelor's degree
- Team management
2d
Clinical Nurse Leader (MIDS) - Emergency Department
Duke Health —Durham, NC
- Full-time
- Nursing
- RN License
- Computer literacy
- Opportunities for advancement
Clinical Nurse Leader (NIGHTS) - Emergency Department
Duke Health —Durham, NC
- Full-time
- Nursing
- RN License
- Computer literacy
- Opportunities for advancement

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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

Apply Now

Refine Your Search

regulatory documentation specialist i jobs in raleigh, nc

QA Specialist (Hybrid)

Regulatory Documentation Specialist I

Administrative Clinical Support Specialist I (Full Time, Remote, North Carolina Based)

Specialist, Risk and Compliance Services (Center of Excellence)

Applications Systems Specialist I – EHRA

Research Administration Program Specialist

Environmental Specialist

Leave Specialist - REMOTE

Customer Care Advocate

NCQA Quality & Accreditation Specialist (Full Time, Remote, North Carolina Based)

FT Staff: Records Specialist-Transfer Credit

Jr. HSE Specialist - Grid Automation

Environmental Specialist

Technical Document Specialist II - Sr. Technical Document Specialist

Food & Beverage Support Specialist

FSP Country Approval Specialist

Country Approval Specialist - FSP

Principal Clinical Trial Coordinator - FSP

Clinical Nurse Leader (MIDS) - Emergency Department

Clinical Nurse Leader (NIGHTS) - Emergency Department

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