-
Quality Manager
1 week ago
Titan Ventures Princeton, United StatesYOUR RESPONSIBILITIES · Ensuring compliance with standards and customer requirements:Summarizing relevant norms and laws · Conducting internal and external audits · Evaluating necessary measures · Collaborating with sales to ensure customer requirements are met · Establishing and ...
-
Manager, Due Diligence Quality
1 day ago
Dow Jones Princeton, United StatesDow Jones is looking for a Quality Manager to join our Due Diligence team responsible for the creation of high-quality reports on companies and/or individuals using a combination of publicly-available sources and proprietary databases. As a Quality Manager, you will be responsibl ...
-
Quality Manager
19 hours ago
Gates Corporation Chambersburg, United StatesAre you inspired by challenging the status quo? Do you thrive in collaborative environments that drive results? If so, Gates could be for you. · Let's simplify it, think belts and hoses. Found in motorcycles, conveyor belts, cars, tractors, blenders, vacuum cleaners, bicycles, & ...
-
Quality Assurance Manager
1 day ago
Star Labs Piscataway, United StatesFounded by an executive team with experts from laboratory and substance treatment programs, Star Labs fills a void that was missing in the testing space. With over 50 years of experience, we provide a sound connection between premier, high quality customer service, and flawless o ...
-
Quality Management Assistant
3 days ago
Centers Plan for Healthy Living Staten Island, United States**Responsibilities**: · - Provides general clerical assistance to the QM Director/Compliance Officer and the QM Clinical Analyst such as faxing, copying, scanning and file maintenance. · - Medical Record Requests: receives and logs requests, obtains necessary authorizations for r ...
-
Quality Management Assistant
3 days ago
Centers Choice Home Care Staten Island, United StatesTitle: Quality Management Assistant · Responsible to: Director Quality Management · **Duties**: · 1. Provides general clerical assistance to the QM Director/Compliance Officer and the QM Clinical Analyst such as faxing, copying, scanning and file maintenance. · 2. Medical Record ...
-
Quality Management Specialist
1 week ago
Spectrum Innovations West Freehold, United StatesResponsibilities: · Focus on a newly created division that develops, manufactures, and distributes products for fertility treatment · Support for all questions related to approvals, as part of the quality management team · Actively participate in communication and coordination ...
-
Quality Management Officer
1 week ago
Nexus Dynamics Pluckemin, United StatesAs a family-owned company founded in 1966 and a global leader in the market, we develop and produce innovative system solutions for wall and floor coverings of the highest quality. From Iserlohn, we successfully market our products and continue to grow worldwide. We have always r ...
-
Quality Manager for Production and
2 weeks ago
Neptune Enterprises Madison Park, NJ, United States Freelance**We are looking for a QUALITY RESPONSIBLE for production and assembly (m/f/d) with experience on behalf of our client.** · **WHAT YOU WILL RECEIVE FROM US:** · - Above-average salary · - Permanent employment contract · - Christmas and vacation pay · - Advance and partial payment ...
-
Quality Assurance Compliance Manager
4 days ago
American Breadcrumb Company Levittown, United States**Safety & Quality Assurance Compliance Manager** · The Food Safety and Quality Assurance Compliance Manager supports and drives compliance in the area of Food Safety for the operators and our customers and works with the warehouses, customers, and suppliers, to provide resolutio ...
-
Quality Management Clinical Analyst
3 days ago
Centers Choice Home Care Staten Island, United StatesTitle: Quality Management Clinical Analyst · Responsible to: Director Quality Management · 1. Incident reporting: logging, investigation, ensures written report on file, assists clinical managers with written reports, collates information on a quarterly basis. Provides education ...
-
Quality Management Clinical Analyst
3 days ago
Centers Plan for Healthy Living Staten Island, United States**Responsibilities**: · - Incident reporting: logging, investigation, ensures written report on file, assists clinical managers with written reports, collates information on a quarterly basis. Provides education to clinical staff regarding risk management and incident reporting. ...
-
Working Quality Assurance Manager
19 hours ago
FORANNE MANUFACTURING INC. Warminster, United StatesMust be versed in AS9100D requirements. · Also, must have either Zeiss Calypso programing experience or CMM Manager programing experience. · Responsibilities will include the following: · Full understanding of GMT · FAI creation and filling out. · CMM programing · Managing and co ...
-
Senior Manager, Quality Compliance
1 week ago
SUN PHARMA Princeton, United StatesJob Summary · Responsible for certification of batches manufactured at applicable site for US/Canada commercial distribution. Manage overall batch certification oversight of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates ...
-
Manager, GMP Quality Assurance
1 week ago
PMV Pharmaceuticals Inc Princeton, United States FreelanceManager, GMP Quality Assurance - Contractor · Reports to: Associate Director, GMP Quality Assurance · Location: Princeton, NJ, Hybrid · This contracting role is responsible for providing GMP QA expertise, oversight and auditing support of contract manufacturing organizations sup ...
-
Manager, Quality Assurance Compliance
4 days ago
Catalent Inc Princeton, United StatesPOSITION SUMMARY Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people li ...
-
Manager, Quality Assurance Compliance
1 week ago
Catalent Inc Princeton, United StatesPOSITION SUMMARY · Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people ...
-
Manager, Quality Assurance Compliance
1 week ago
Catalent Inc Princeton, United StatesPOSITION SUMMARY Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people li ...
-
Manager, Quality Assurance Compliance
4 hours ago
Catalent Inc Princeton, United StatesPOSITION SUMMARY · Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people ...
-
Manager, Quality Assurance Compliance
2 days ago
Catalent Inc Princeton, United States**POSITION SUMMARY** · Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help pe ...
Quality Manager - Princeton, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed
Ability to work independently on problems and issues and determine acceptable solutions and approaches
Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed
Understands quality by design principles and how to define critical process parameters.
Can conduct FMEA to assess risk and identify risk mitigation actions
Complete Annual Product Quality Reports (APQR)
Review statistical analysis that measures process capability and trending performance.
Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.
Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing
Requirements:
Experience managing client/vendor relationships
Required knowledge of manufacturing/packaging operations; including environmental monitoring, drug product manufacturing/packaging, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing
Experience supporting cross-functional project teams
Experience dealing with external supply world, contract manufacturing
Product knowledge of Non Sterile Products- tablets, capsules, ointments/creams, etc.
Experience in TrackWise based system or similar systems- customer complaints, deviations, etc.
Strong Communication Skills both oral and written- Savy in electronic systems as well
Requires knowledge of Quality Systems, FDA GxP regulations and guidance for pharmaceutical manufacturing.
Requires excellent verbal/written communication, negotiation/influencing, leadership and risk assessment skills.
Experience in negotiation/influencing and management of remote third party partners
Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases
B.S.
Degree in Engineering or Science or equivalent with a minimum of 5 years pharmaceutical industry experience (may include Operational/Quality/Compliance/Validation experience in pharmaceutical industry).
Experience in managing client/vendor relationshipsRequired knowledge of manufacturing/packaging operations in the pharmaceutical industry
Experience supporting cross-functional project teams
#J-18808-Ljbffr