Top 22 Senior qa specialist Jobs in Durham Nc

Senior QA Specialist Deviations and CAPAs
KBI Biopharma —Durham, NC
- Full-time
- Bachelor of Science
- 11+ years
- Bachelor's degree
Senior QA Technical Specialist
FUJIFILM —Research Triangle Park, NC
- Master's degree
- High school diploma or GED
- Bachelor's degree
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
11d
Sr. Specialist, Compliance QA
Indivior —Raleigh, NC
- $88,000 - $108,000 a year
- Full-time
- 5 years
- ERP systems
- Computer skills
- Profit sharing
- Employee stock purchase plan
Senior Director, Technical Training
Reworld Projects, LLC —Raleigh, NC
- $180,600 - $258,100 a year
- Full-time
- Hybrid work
- Engineering
- 11+ years
- Supervising experience
- Paid parental leave
- Health savings account
Quick Apply
2d
Specialist II/III, QA
CSL Seqirus —Holly Springs, NC
- Full-time
- Mid-level
- Bachelor's degree
- Warehouse
5d
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
Senior Specialist 2, QC LIMS
FUJIFILM —Holly Springs, NC
- Call employer
- Microsoft Outlook
- ERP systems
- Bachelor's degree
3d
EDI Specialist
Software Technology Inc —Raleigh, NC
- HIPAA
- Office
- Continuous improvement
Quick Apply
Senior Webflow Developer & CRO Specialist
Short Story —Raleigh, NC
- $115,000 - $135,000 a year
- Full-time
- 3 years
- Analysis skills
- Senior level
Quick Apply
Digital Advertising Delivery Specialist
Wiley —Cary, NC
- $48,800 - $66,733 a year
- Full-time
- Hybrid work
- Mid-level
- Communication skills
Data Service Group Specialist - North Hills, NC
Advyzon —Raleigh, NC
- $60,000 - $70,000 a year
- Full-time
- Computer science
- Computer Science
- Mid-level
Quick Apply
4d
Senior Turbine Reliability Specialist
Reworld Projects, LLC —Raleigh, NC
- $136,600 - $195,300 a year
- Full-time
- Microsoft Outlook
- Engineering
- Office
- Paid parental leave
- Health savings account
Quick Apply
12d
Manager, QA
CSL Seqirus —Holly Springs, NC
- Full-time
- 5 years
- Experience equivalent to degree accepted
- Senior level
- Health insurance
- Dental insurance
9d
Enterprise Surgical Sales Executive, Southeast
Owens & Minor Distribution Inc. —Raleigh, NC
- $100,000 - $120,000 a year
- Full-time
- Clean driving record
- 7 years
- Microsoft Excel
- Health savings account
- Disability insurance
Quick Apply
GIS Specialist
Intellibee —Raleigh, NC
- Overtime
- Databases
- Quality control
- Travel
- Health insurance
- 401(k)
Salesforce Solutions Engineer
Intellibee —Raleigh, NC
- 5 years
- Mentoring
- Senior level
- Health insurance
- 401(k)
Environmental Planner - Mid to Senior Level
Moffatt & Nichol —Raleigh, NC
- Full-time
- Background check
- Bachelor of Science
- Research
Quick Apply
Manager, Environmental Operations
Quanta Infrastructure Solutions Group, LLC —Raleigh, NC
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
- Paid parental leave
- Health savings account
Manager, Environmental Operations
Quanta Services —Raleigh, NC
- Hybrid work
- Master's degree
- Bachelor's degree
- Continuous improvement
- Paid parental leave
- Health savings account

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senior qa specialist jobs near durham nc

Senior QA Specialist Deviations and CAPAs

KBI Biopharma -
Durham, NC

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Job Details

Full-time

Qualifications

Quality control corrective actions
Preventive action implementation
Production deviation management
Corrective and preventive actions (CAPA)
GMP
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Regulatory/legal compliance standards in production
Production batch record review
Pharmaceutical manufacturing facility experience

Full Job Description

Job Summary:

Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations. Support timely review of events for classification, initiation in EtQ and closure. Support external client review and resolution of comments for assigned deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. Provide metrics to management as requested.

Job Responsibilities:

Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Review and approve Deviations and CAPAs
Facilitates triage meetings, performing classifications of DTRs
Collaborates with functional areas to improve the Deviation/CAPA system to include support in development of training materials and training personnel. Works to streamline these processes.
Attends relevant operational and project meetings. Support client audits and regulatory inspections as required.
Provides training for Deviation and CAPA TRNs to KBI staff.
Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs

Minimum Requirements:

Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent. Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs. Knowledge of US, EU and Row cGMP guidelines required.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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Refine Your Search

senior qa specialist jobs in durham nc

Senior QA Specialist Deviations and CAPAs

Senior QA Technical Specialist

Senior Specialist Quality Assurance, CSV

Sr. Specialist, Compliance QA

Senior Director, Technical Training

Specialist II/III, QA

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

Senior Specialist 2, QC LIMS

EDI Specialist

Senior Webflow Developer & CRO Specialist

Digital Advertising Delivery Specialist

Data Service Group Specialist - North Hills, NC

Senior Turbine Reliability Specialist

Manager, QA

Enterprise Surgical Sales Executive, Southeast

GIS Specialist

Salesforce Solutions Engineer

Environmental Planner - Mid to Senior Level

Manager, Environmental Operations

Manager, Environmental Operations

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