Quality Assurance Jobs in Durham, NC - NOW HIRING

1,424 jobs found

- Eli Lilly and Company
- Durham, NC 27703 (Harrington Pines area)
$150,000 - $200,000a year
The Associate Director, Quality Assurance (QA) – Parenteral, is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of parenteral manufacturing operations at the Alzey site. .
Full-Time / Part-Time / Permanent / Temporary / Contract / Internship
German
Bachelor's Degree
NEW
Today
- Eli Lilly and Company
- Durham, NC 27703 (Harrington Pines area)
$150,000 - $200,000a year
The Associate Director, Quality Assurance (QA) – Device Assembly and Packaging (DAP), is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device assembly and packaging ...
Full-Time / Part-Time / Permanent / Temporary / Contract / Internship
German
Bachelor's Degree
NEW
Today
- Piper Companies
- Durham, NC 27703 (Harrington Pines area)
- Remote
$120,000 - $200,000a year
Quality assurance pharmaceutical experience, with clinical research, GCP, GMP, and QA compliance experience. ... Partner with Clinical, CMC, and non-clinical development teams, external vendors, and investigator sites to provide GXP QA oversight, ...
401(k)
Health Insurance
GCP
Paid Time Off
NEW
Today
- Tbwa Chiat/Day Inc
- Durham, NC 27703 (Harrington Pines area)
$150,000 - $200,000a year
The Associate Director of Quality Assurance is responsible and accountable for all aspects of the Quality Assurance. ... Act as the main interface between Kincell Bio Quality and client Quality; ensures the status and progress of projects is on ...
Contract
9 days ago
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- Corning
- Durham, NC 27712
- Remote
$160,886 - $221,219a year
Minimum of 10 years' experience in Quality Assurance or Regulatory (preferably in a medical device regulated manufacturing environment) with 5 years of experience in a plant quality management role. ... Manage and maintain the plants' Quality ...
Full-Time / Permanent
Paid Time Off
Professional Development Assistance
Parental Leave
401(k)
Life Insurance
NEW
Today
- Corning Incorporated
- Durham, NC
- Remote
$160,886 - $221,219a year
Minimum of 10 years’ experience in Quality Assurance or Regulator ... Manage and maintain the plants’ Quality Systems and all related activities to ensure that the products, both manufactured and purchased, meet customer and all applicable ...
Full-Time / Permanent
Health Insurance
Parental Leave
Life Insurance
Paid Time Off
Professional Development Assistance
NEW
Today
- Randstad Enterprise
- Durham, NC
Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management System ... Quality Assurance Associate - Large and Small Scale Biomanufacturing - ... Experienced QA associate ...
Full-Time / Contract
Overtime
NEW
Today
- Medasource
- Durham, NC
The Parenteral QA Floor Representative will provide on-the-floor quality oversight for the manufacturing of sterile injectable drug products. ... Experience in pharmaceutical QA oversight, particularly in sterile injectable manufacturing.
Flexible Schedule
Bachelor's Degree
NEW
Today
- Planet Pharma
- Durham, NC
Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents ...
NEW
Today
- Jobleads-US
- Durham, NC 27703 (Harrington Pines area)
The Associate Director, Quality Assurance (QA) – Parenteral, is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of parenteral manufacturing operations at the Alzey site. .
German
Bachelor's Degree
NEW
Today
- FST Technical Services
- Durham, NC
We are looking for Quality Assurance/Inspector Representatives with experience in Welding/Piping to join our teams in the Durham, NC area! ... Plans and directs activities concerned with development, application, and maintenance of quality standards ...
Full-Time
Vision Insurance
Health Insurance
Dental Insurance
Paid Time Off
401(k)
24 days ago
- Jobleads-US
- Durham, NC 27703 (Harrington Pines area)
The Associate Director, Quality Assurance (QA) – Device Assembly and Packaging (DAP), is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device assembly and packaging ...
German
Bachelor's Degree
NEW
Today
- Food Lion
- Durham, NC 27722
At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to ...
Full-Time / Part-Time / Permanent / Temporary / Contract / Internship
Training Provided
NEW
1 day ago
- KBI Biopharma Inc
- Durham, NC 27703 (Harrington Pines area)
$205,000a year
The Senior Director of Quality, Quality Site Head is accountable for raw material release, Quality on the floor, disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and ...
Contract
Doctoral Degree
NEW
Today
- The Fountain Group
- Durham, NC
$20 - $30an hour
The Quality Assurance Associate is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Research Triangle Park (RTP) facility. ... Assists Quality Assurance Management in additional ...
High School Degree
NEW
Today

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Associate Director, Quality Assurance - Parenteral

Apply on Company Site

Company
Eli Lilly and Company
Location
Durham, NC 27703 (Harrington Pines area)
Job Type
Full-Time / Part-Time / Permanent / Temporary / Contract / Internship
Salary
$150,000 - $200,000 a year

German

Bachelor's Degree

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance (QA) – Parenteral, is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of parenteral manufacturing operations at the Alzey site. This includes quality oversight of project delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection. This individual is responsible for process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.

Responsibilities:

Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in DAP.
Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team.
Support the development of the overall site operational readiness plan including development of quality processes and approval of parenteral operational procedures.
Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for parenteral operations.
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
Engage team and delegate to achieve results through others to deliver according to plan.
Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
Demonstrate flexibility with quick response as priorities change or issues arise.
Partner with production and design organization to ensure 24/7 Quality oversight and support.
Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation.
Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc. for DAP operations.
Network with global and other parenteral sites to understand best practices, share knowledge.
Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management.
Set area human resource and business plan goals.
Participate in tactical and strategic business planning.
Communicate on project and production status.
Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections.

Basic Requirements:

Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
Minimum 7 years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group.
Minimum 7 years’ experience directly supporting parenteral manufacturing operations.
Fluent in English and German.
On-site presence required.

Additional Skills/Preferences:

Strong knowledge of Quality Management Systems and applicable regulatory requirements.
Previous regulatory inspection readiness and inspection execution experience.
Previous facility or area start up experience.
Previous equipment qualification and process validation experience.
Previous experience with SAP or other inventory management systems.
Previous experience with parenteral manufacturing including contamination control, environmental monitoring, aseptic process simulation, cleaning and sterilization validation, isolator technology, visual inspection.
Previous experience with Manufacturing Execution Systems and electronic batch release.
Previous experience with deviation and change management systems including Trackwise or Veeva.
Excellent interpersonal, written and oral communication skills.
Strong technical aptitude and ability to train and mentor others.
Demonstrated technical writing skills.
Demonstrated problem-solving and decision-making skills.

Additional Information:

Flex hours possible.
Primary location is Alzey, Germany.
Ability to travel (approximately 10-20 %).
Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role.

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Industry

Biotech, Pharma & Chemistry

Job Category1

Management & Operations

Job Category2

Quality Management & Operations

: Location
Durham, NC 27703
Remote Work Availability
no

: Salary
$150.000 - 200.000

: Company
Eli Lilly and Company

Apply on Company Site

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