Quality Assurance Specialist
3 months ago
This position is responsible for authoring, reviewing, and approving deviations and non-conformances within a biologics manufacturing setting. Strong experience in upstream processes and/or cell/gene therapy.
Key Responsibilities:
- Deviation and Investigation Writing: Draft 5-7 minor deviations per week with 5-6 approved, or 3-5 major deviations weekly.
- Unit Operations Expertise: Including cell culture, bioreactors, TFF, chromatography, and filtrations.
- Single-Use Disposable Systems: Experience with these systems.
- Root Cause Analysis (RCA): Familiarity with 5 Whys, 6Ms, and fishbone diagrams.
- TrackWise System: Experience with TrackWise or similar systems.
Must-Have Qualifications:
- Upstream and/or Cell/Gene Therapy Experience
- Proven Experience in Authoring Deviations/Investigations
- Strong Biologics Experience
- Familiarity with cGMP Manufacturing Environments
- Strong Writing Skills
- Life Science or Engineering Degree with at least 5 years of relevant experience
-
Quality Specialist
1 day ago
Harmans, United States LanceSoft, Inc. Full timeTitle: QA SpecialistLocation: Harmans MD 21077Duration: 3 Months (Possibility for Extension or Conversion for Full-Time)POSITION SUMMARY The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption....
-
Quality Specialist
6 days ago
harmans, United States LanceSoft, Inc. Full timeTitle: QA SpecialistLocation: Harmans MD 21077Duration: 3 Months (Possibility for Extension or Conversion for Full-Time)POSITION SUMMARY The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption....
-
Quality Specialist
5 days ago
harmans, United States LanceSoft, Inc. Full timeTitle: QA SpecialistLocation: Harmans MD 21077Duration: 3 Months (Possibility for Extension or Conversion for Full-Time)POSITION SUMMARY The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption....
-
Quality Specialist
1 week ago
Harmans, United States LanceSoft, Inc. Full timeTitle: QA SpecialistLocation: Harmans MD 21077Duration: 3 Months (Possibility for Extension or Conversion for Full-Time)POSITION SUMMARY The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption....
-
Senior Quality Assurance Manager
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Senior Quality Assurance Manager to join our team.The successful candidate will be responsible for providing support and oversight to the Quality Control Team as they support the Quality Control and Batch Disposition...
-
Senior Quality Assurance Supervisor
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Summary:The Senior Quality Assurance Supervisor will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.Key Responsibilities:Supervise Client Support processes and personnel.Ensure staff are fully trained on all cGMP manufacturing...
-
Senior Quality Assurance Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will drive engagement and create a culture where employees are motivated to do their best. The successful candidate will...
-
Senior Quality Assurance Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will build effective teams that apply their diverse skills and perspectives to achieve common goals, drive engagement, and...
-
Quality Assurance Specialist
4 weeks ago
Harmans, Maryland, United States LanceSoft, Inc. Full timeJob Title – QA Batch Record ReviewerLocation – LanceSoft, Inc.Duration: 3 months contract possibly extensionPay Range: $30.00 - $35.00 USD hourly on W2ResponsibilitiesPerform Product Disposition and Lot Closure, ensuring commercial and clinical products meet regulatory standards.Review batch-related documentation to resolve issues and release products,...
-
Director, Quality Assurance Batch Release Leader
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeDirector, Quality Assurance Batch ReleaseAbout the RoleThe Director, Quality Assurance Batch Release provides strategic oversight and leadership to QA Batch Record Review and Release supporting clinical and commercial drug substance and drug product manufacturing. This role ensures project objectives are met to a high-quality standard and according to...
-
Quality Assurance Specialist
3 months ago
Harmans, United States LanceSoft, Inc. Full timeJob Title – QA Batch Record ReviewerLocation – 7555 Harmans Rd, Harmans, MD 21077Duration : 3 months contract possibly extensionPay Range : $40.00 - $45.00 USD hourly on W2ResponsibilitiesPerform Product Disposition and Lot Closure. Includes commercial and clinical products.Review batch-related documentation and ensure resolution of issues to release...
-
Quality Specialist
5 days ago
Harmans, MD, United States LanceSoft, Inc. Full timeTitle: QA SpecialistLocation: Harmans MD 21077Duration: 3 Months (Possibility for Extension or Conversion for Full-Time)POSITION SUMMARY The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption....
-
Senior Specialist, QA OTF
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Quality Assurance Specialist to provide support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The ideal candidate will have a strong background in Quality Assurance, Good Manufacturing Practices (GMPs), and biologics/biopharmaceuticals.Key...
-
Quality Control Manager
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Manager, QC Program Management is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation.Key ResponsibilitiesBe the face of Catalent Quality Control...
-
Quality Control Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Manager, QC Client Services is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation.Key ResponsibilitiesManage the OTL for analytical method...
-
Quality Systems Audit Manager
4 weeks ago
Harmans, Maryland, United States Catalent Pharma Solutions Full timeJob Title: Quality Systems Audit ManagerCatalent Pharma Solutions is seeking a highly skilled Quality Systems Audit Manager to join our team. As a key member of our quality assurance department, you will be responsible for managing and overseeing the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk...
-
Quality Control Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeAbout the RoleThe Manager, QC Program Management is responsible for providing strategic support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables are met as part of client's analytical implementation.Key ResponsibilitiesManage the OTL for...
-
Quality Systems Audit Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Quality Systems Audit Manager to join our team. As a key member of our quality assurance department, you will be responsible for managing and overseeing the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, and quality metric tracking.Key...
-
Senior Specialist, Batch Disposition
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Senior Specialist, Batch Disposition to join our team. As a key member of our Quality Assurance department, you will be responsible for providing quality assurance support for GMP documentation of master/working cell banks, bulk drug substance, and finished drug product.Key Responsibilities* Review...
-
Biologics Manufacturing Specialist
3 weeks ago
Harmans, Maryland, United States LanceSoft, Inc. Full timeJob Title: Quality Assurance SpecialistThis role is responsible for ensuring the quality and integrity of biologics manufacturing processes. The ideal candidate will have strong experience in upstream processes and/or cell/gene therapy.Key Responsibilities:Deviation and Investigation Writing: Draft and approve deviations and investigations with a focus on...