Top 489 Quality documentation specialist 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
Clinical Documentation Specialist position
EAPPS TECH LLC dba Magicforce —Raleigh, NC
- $40 - $60 an hour
- RN License
- Mid-level
- 1 year
Quick Apply
HR Learning & Development Specialist
Easterseals PORT Health —Raleigh, NC
- $65,000 a year
- Email
- Mid-level
- Office
- Driver's License
- Paid holidays
- Disability insurance
Quick Apply
MRI Technologist-Hospital
WakeMed Health & Hospitals —Raleigh, NC
- Patient monitoring
- Hospital
- Mid-level
Radiology Technologist
WakeMed Health & Hospitals —Raleigh, NC
- Full-time
- Patient monitoring
- Inpatient
- Mid-level
MRI Technologist-Hospital
WakeMed Health & Hospitals —Raleigh, NC
- Patient monitoring
- Hospital
- Mid-level
Restaurant Manager
The Catering Works Inc —Raleigh, NC
- From $28 an hour
- Weekends as needed
- Restaurant management
- Mid-level
- Continuous improvement
AMP Property Manager
Housing Authority of the County of Wake —Zebulon, NC
- $37,000 - $43,000 a year
- Full-time
- Writing skills
- Pass drug screening
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Lead Building Automation Specialist - Raleigh, NC
Honeywell —Raleigh, NC
- Full-time
- Hospital
- Mid-level
- Office
- Health savings account
- Paid holidays
Quick Apply
Electrical Safety Specialist
Adams Electric Company —Raleigh, NC
- Microsoft Excel
- Microsoft Outlook
- Construction site
Quick Apply
Radiologic Technologist up to $10K Bonus
Concentra —Raleigh, NC
- Full-time
- CPR Certification
- Microsoft Excel
- Vital signs
- Commuter assistance
- Disability insurance
Collections Specialist
Career Foundations —Morrisville, NC
- $50,000 - $56,000 a year
- Overtime
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
4d
Clinical Nurse Leader (MIDS) - Emergency Department
Duke Health —Durham, NC
- Full-time
- Nursing
- RN License
- Computer literacy
- Opportunities for advancement
Recreational Therapist- PRN
Raleigh Oaks Behavioral Health —Garner, NC
- Part-time
- Mid-level
- Master's degree
- Bachelor's degree
Quick Apply
10d
Military Service - Air Force Reserve, Air Transportation
Military Service - Air Force Reserve —Raleigh-Durham, NC
- From $40,000 a year
- Part-time
- Mid-level
- Driver's License
- Health insurance
- Tuition reimbursement
Registered Nurse
Sevita —Raleigh, NC
- Full-time
- CPR Certification
- Nursing
- RN License
Electrical Quality Specialist
Adams Electric Company —Raleigh, NC
- $22 - $35 an hour
- On call
- Construction site
- Mid-level
- Analysis skills
Quick Apply
Mental Health Group Facilitator - Master's Degree Required
Charlie Health —North Carolina
- Part-time
- Remote
- Background check
- Master of Social Work
- Mid-level
Quick Apply
Delivery & Customer Experience Specialist
Kimbrell's Home Furnishings —Durham, NC
- Weekends as needed
- Spanish
- Clean driving record
- Merchandising
- Health insurance
- Dental insurance
Quick Apply
MRI Technologist (Per Diem)
UNC Health —Chapel Hill, NC
- $33.37 - $47.95 an hour
- Per diem
- Anatomy knowledge
- BLS Certification
- Mid-level

I want to receive the latest job alert for quality documentation specialist in raleigh, nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality documentation specialist jobs near raleigh, nc

Group Facilitator jobs in North Carolina

Property Manager jobs in Zebulon, NC

MRI Technologist jobs in Chapel Hill, NC

Quality Assurance Specialist jobs in Raleigh, NC

Automation Technician jobs in Raleigh, NC

MRI Technologist jobs in Raleigh, NC

Registered Nurse jobs in Raleigh, NC

Café Manager jobs in Raleigh, NC

Customer Experience Specialist jobs in Durham, NC

Radiologic Technologist jobs in Raleigh, NC

Quality Specialist jobs in Raleigh, NC

Clinical Documentation Specialist jobs in Raleigh, NC

Safety Specialist jobs in Raleigh, NC

Group Facilitator jobs in Sugar Land, TX

Haselwood Auto Group jobs in Bremerton, WA

Group Facilitator jobs in Pompano Beach, FL

Prysmian Group jobs in Abbeville, SC

Group Facilitator jobs in Wildomar, CA

Tao Group Hospitality jobs in New York, NY

Group Facilitator jobs in West Chester, PA

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

quality documentation specialist jobs in raleigh, nc

QA Specialist (Hybrid)

Clinical Documentation Specialist position

HR Learning & Development Specialist

MRI Technologist-Hospital

Radiology Technologist

MRI Technologist-Hospital

Restaurant Manager

AMP Property Manager

Lead Building Automation Specialist - Raleigh, NC

Electrical Safety Specialist

Radiologic Technologist up to $10K Bonus

Collections Specialist

Clinical Nurse Leader (MIDS) - Emergency Department

Recreational Therapist- PRN

Military Service - Air Force Reserve, Air Transportation

Registered Nurse

Electrical Quality Specialist

Mental Health Group Facilitator - Master's Degree Required

Delivery & Customer Experience Specialist

MRI Technologist (Per Diem)

I want to receive the latest job alert for quality documentation specialist in raleigh, nc

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected