Top 26 Senior quality assurance analyst Jobs in Durham, Nc

Chemist III/Sr. Chemist Raw Materials
MedPharm —Durham, NC
- Full-time
- 5 years
- Bachelor of Science
- Data analysis skills
Quick Apply
Senior Analyst 1, QC Compendial Testing
Fujifilm —Holly Springs, NC
- Call employer
- Computer literacy
- No experience needed
- English
2d
Senior IT Asset Mgmt Analyst
First Citizens Bank —Raleigh, NC
- Full-time
- Remote
- Mid-level
- Office
- High school diploma or GED
Quality Assurance Engineer III- Hardware Development
Toshiba Global Commerce Solutions - External —Durham, NC
- Computer Science
- 5 years
- Engineering
- Paid holidays
- Health insurance
Quick Apply
11d
Senior Programmer / Analyst
Meredith College —Raleigh, NC
- Weekends as needed
- Computer science
- Computer Science
- Customer service
Senior Analyst 1, QC Chemistry
FUJIFILM —Holly Springs, NC
- Call employer
- Mid-level
- Ability to sit for extended periods
- 1 year
Business Systems Analyst, LIMS
NeoGenomics Laboratories —Durham, NC
- Monday to Friday
- Computer science
- Computer Science
- 5 years
- Employee stock purchase plan
- Paid holidays
Quick Apply
2d
Lead Data Engineer
MetLife —Cary, NC
- $120,000 - $180,000 a year
- Email
- Hybrid work
- Office
- SQL
- Travel
- Paid holidays
- Disability insurance
Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)
United Therapeutics —Research Triangle Park, NC
- Full-time
- Microsoft Outlook
- Master's degree
- Analysis skills
- Paid parental leave
- Employee stock purchase plan
Medical Assistant - Clinic
Curana Health —Raleigh, NC
- Full-time
- Vital signs
- Clinic
- Older adults
10d
Service Delivery Center, Java Developer: Full Stack or Back End-Financial Services -Senior
EY —Raleigh, NC
- $67,000 - $155,300 a year
- Computer science
- Azure
- Computer Science
- Paid holidays
- Health insurance
Audit - Valuation & Analytics - Consultant
Deloitte —Raleigh, NC
- $67,950 - $136,375 a year
- Full-time
- CPA
- Research
- Mid-level
5d
Mainframe Modernization Senior Manager
Accenture —Raleigh, NC
- $122,700 - $302,400 a year
- Full-time
- Hybrid work
- Azure
- 6 years
- DevOps
- Paid holidays
- Disability insurance
Senior Vice President of Product
Digital.ai —Raleigh, NC
- $250,000 - $275,000 a year
- Full-time
- Remote
- Writing skills
- 11+ years
- Analysis skills
- Paid parental leave
- Health insurance
Quick Apply
Board Certified Behavior Analyst (BCBA) - Wake Forest, NC
Kind Behavioral Health —Wake Forest, NC
- Full-time
- Mid-level
- Clinic
- Analysis skills
- AD&D insurance
- Paid holidays
Quick Apply
Cyber Senior Consultant - AI SOC
Deloitte —Raleigh, NC
- $105,400 - $207,800 a year
- Full-time
- Azure
- 6 years
- Computer Science
Board Certified Behavior Analyst (BCBA) - Holly Springs, NC
Kind Behavioral Health —Holly Springs, NC
- Full-time
- Mid-level
- Clinic
- Analysis skills
- AD&D insurance
- Paid holidays
Quick Apply
Board Certified Behavior Analyst (BCBA) - Raleigh, NC
Kind Behavioral Health —Raleigh, NC
- Full-time
- Mid-level
- Clinic
- Analysis skills
- AD&D insurance
- Paid holidays
Quick Apply
Board Certified Behavior Analyst (BCBA) - Durham, NC
Kind Behavioral Health —Durham, NC
- Full-time
- Mid-level
- Clinic
- Analysis skills
- AD&D insurance
- Paid holidays
Quick Apply
Profitability & Costing Senior Manager
Deloitte —Raleigh, NC
- $193,700 - $322,900 a year
- Full-time
- CPA
- Up to 50% travel
- Finance

I want to receive the latest job alert for senior quality assurance analyst in durham, 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

senior quality assurance analyst jobs near durham, nc

Chemist III/Sr. Chemist Raw Materials

MedPharm -
Durham, NC

Quick Apply

Job Details

Full-time

Qualifications

Bachelor's degree
Materials analysis (analytical chemistry specialty)
Manufacturing company experience
Stakeholder relationship building

Full Job Description

Position Summary – The Chemist III/Sr. Chemist Raw Materials ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients

Essential Functions

Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines.
Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements
Interact with third party laboratories for microbial and analytical testing of raw materials
Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
Create purchase requisitions for lab supplies and third-party testing
Perform weekly laboratory audit inspections
Perform sampling of raw materials as needed
Review third party laboratory investigations and protocols.
Execute intermediate to advanced chemical and instrumental testing of raw materials using HPLC, GC, FTIR, UV-Vis, Karl Fischer titration, and wet chemistry.
Ensure all testing meets compendial standards (USP/EP/JP) and regulatory expectations. Conduct peer reviews of data, Certificates of Analysis (COAs), and laboratory logbooks.
Author and review GMP documentation including Standard Operating Procedures (SOPs), protocols, deviations, Corrective and Preventive Actions (CAPAs), and change controls.
Provide technical guidance to junior analysts. Lead method verification, validation, and method transfer activities for incoming raw materials.
Oversee the calibration, maintenance, and troubleshooting of laboratory equipment.
Other duties as assigned

Supervisory responsibilities

Direct Reports: No
Indirect Reports: None

Key Relationships

Manufacturing Operations
Quality Assurance
Analytical R&D
Program Management

Travel requirements:

None

Education and Experience

Minimum BA or BS in a scientific discipline required
Minimum 5-8 years of Analytical chemistry experience with a cGMP/GLP environment, preferably at a CDMO or pharmaceutical company.

Knowledge, Skills, and Abilities

Knowledge of cGMPs
Good communication, organization and computer skills are required.
Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired.
Ability and willingness to work additional hours as required by business need
At least 5 years’ experience in a CRO environment
Experience with USP, EP and JP monographs.
Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size.
Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
Excellent verbal and written communication skills
Ability to work with minimal supervision
Experience in Data Review of Analytical data per GDP guidelines.
Proven ability to review and evaluate the compliance and completeness of analytical data.
Able to multi-task productively, applying time management processes and procedures effectively.
Works toward common goals by supporting, encouraging, and sharing information with colleagues.
Strong analytical skills and ability to understand business and financial implications of contracts
Self-directed

Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.

Requires frequent sitting and walking
Requires carrying under 20 LBS, occasionally 20 – 60 LBS
Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS
Requires occasional bending, twisting, reaching, & gripping
Requires constant seeing & hearing

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

9s721DUGQ2

Quick Apply

Refine Your Search

senior quality assurance analyst jobs in durham, nc

Chemist III/Sr. Chemist Raw Materials

Senior Analyst 1, QC Compendial Testing

Senior IT Asset Mgmt Analyst

Quality Assurance Engineer III- Hardware Development

Senior Programmer / Analyst

Senior Analyst 1, QC Chemistry

Business Systems Analyst, LIMS

Lead Data Engineer

Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)

Medical Assistant - Clinic

Service Delivery Center, Java Developer: Full Stack or Back End-Financial Services -Senior

Audit - Valuation & Analytics - Consultant

Mainframe Modernization Senior Manager

Senior Vice President of Product

Board Certified Behavior Analyst (BCBA) - Wake Forest, NC

Cyber Senior Consultant - AI SOC

Board Certified Behavior Analyst (BCBA) - Holly Springs, NC

Board Certified Behavior Analyst (BCBA) - Raleigh, NC

Board Certified Behavior Analyst (BCBA) - Durham, NC

Profitability & Costing Senior Manager

I want to receive the latest job alert for senior quality assurance analyst in durham, nc

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected