Top 83 Manufacturing 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
Associate Manufacturing Specialist
Alcami Corporation —Morrisville, NC
- Extended hours
- Microsoft Excel
- Mid-level
- Ability to lift 50 pounds
3d
Manufacturing Operations Specialist
Katalyst Healthcares & Life Sciences —Durham, NC
- Contract
- Hybrid work
- Mid-level
- Associate's degree
Quick Apply
Process Expert
Novartis —Durham, NC
- $85,400 - $158,600 a year
- Full-time
- Mid-level
- Continuous improvement
- In-person
- Health insurance
- 401(k) matching
Stair Installation Technician & Delivery Specialist
Southern Staircase —Raleigh, NC
- $23 - $25 an hour
- Overtime
- Construction site
- Mid-level
- Residential
- Paid holidays
- Health insurance
Data Review (QC Specialist) 6-Mo Contract
BioAgilytix —Durham, NC
- Contract
- Mid-level
- Master's degree
- Bachelor's degree
- Health savings account
- Paid holidays
Quick Apply
2d
Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3
Alcami Corporation —Morrisville, NC
- 12 hour shift
- 5 years
- Master's degree
- Databases
QA Systems Specialist
Kelly Services —Raleigh, NC
- $76,000 - $110,000 a year
- Overtime
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid holidays
- Disability insurance
Quick Apply
13d
Manufacturing Specialist 1, Materials
FUJIFILM —Holly Springs, NC
- Call employer
- Military
- Mid-level
- High school diploma or GED
Manufacturing Quality Assurance Specialist
Novartis —Durham, NC
- $43.08 - $80.00 an hour
- Full-time
- 5 years
- Bachelor of Science
- Analysis skills
- Health insurance
- 401(k) matching
10h
Specialist Manufacturing Investigations
Amgen —Holly Springs, NC
- $107,545.40 - $145,502.60 a year
- Doctoral degree
- Engineering
- Master's degree
- Disability insurance
- Health insurance
Senior QA Specialist, External Manufacturing, US
Bavarian Nordic —Durham, NC
- $120,000 - $155,000 a year
- Full-time
- Remote
- Travel
- Senior level
- Communication skills
Operations Area Specialist - SDF (2nd shift)
Novo Nordisk —Durham, NC
- Microsoft Outlook
- 5 years
- Bachelor of Science
- Paid holidays
- Disability insurance
7d
QA Area Specialist I - SDF (2nd shift)
Novo Nordisk —Durham, NC
- 6 years
- Computer literacy
- Mid-level
- Paid holidays
- Disability insurance
Quality Assurance Specialist
Science Corporation —Durham, NC
- Mid-level
- Continuous improvement
- Fair chance
Sr. Manufacturing Specialist I
Biogen —Research Triangle Park, NC
- $98,000 - $127,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Senior level
- Paid parental leave
- Employee stock purchase plan
1d
Manufacturing Training Specialist – Manufacturing Support
Amgen —Holly Springs, NC
- $107,545.40 - $145,502.60 a year
- Doctoral degree
- 3 years
- High school diploma or GED
Plant Operations Specialist (WithOUT Certification)
City of Durham —Durham, NC
- $52,606 - $74,022 a year
- Multiple hires
- Basic math
- CDL
- High school diploma or GED
- Paid holidays
- Disability insurance
Quality Specialist III
Precision Biosciences —Durham, NC
- 5 years
- Travel
- Senior level
Specialist, Quality Assurance
FUJIFILM —Research Triangle Park, NC
- English
- 3 years
- Master's degree
- Wellness program
- Health savings account

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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

manufacturing specialist jobs in durham, nc

QA Specialist (Hybrid)

Associate Manufacturing Specialist

Manufacturing Operations Specialist

Process Expert

Stair Installation Technician & Delivery Specialist

Data Review (QC Specialist) 6-Mo Contract

Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3

QA Systems Specialist

Manufacturing Specialist 1, Materials

Manufacturing Quality Assurance Specialist

Specialist Manufacturing Investigations

Senior QA Specialist, External Manufacturing, US

Operations Area Specialist - SDF (2nd shift)

QA Area Specialist I - SDF (2nd shift)

Quality Assurance Specialist

Sr. Manufacturing Specialist I

Manufacturing Training Specialist – Manufacturing Support

Plant Operations Specialist (WithOUT Certification)

Quality Specialist III

Specialist, Quality Assurance

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