QA Manager Operations, 3rd Party
4 days ago
SUMMARY OF POSITION
The QA Manager Operations, Third Party U.S. provides quality and compliance oversight of third party contractors and external partners for Alvogen Inc. for distribution in the U. S. market.
ORGANIZATION STRUCTURE
The QA Manager Operations, Third Party reports to the Associate Director, Operations of Third Party U. S. Quality. This position supports Alvogen's commercial business, and works closely with Supply Chain, Project Management, Regulatory Affairs, Sales and Marketing, and external suppliers and partners. The position has no direct reports, and works along other Managers, Third Party Quality, QA Associates, and Sr.QA Associates.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
1. Handles day-to-day Quality responsibilities for assigned products manufactured by Third party suppliers and distributed by Alvogen in the US
2. Performs batch record review and release for Third party manufactured products
3. Reviews and approves Deviations, Investigations and Change Controls associated with Third party manufactured products
4. Reviews and ensures that Annual Product Reviews, Stability Management, and Retain / Reserve Sample management systems are in compliance for Third Party manufactured products
5. Tracks metrics for external businesses partners/CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third party QA KPIs (Key Performance Indicator).
6. Supports tech transfers, validations and product launches by performing the quality review and approval of process validation protocols and reports, method validation protocols and reports, specifications and test methods, and raw material, component, and product specifications
7. Performs the review and approval of labeling and packaging specifications
8. Supports the Quality department with revision of Standard Operating Procedures
9. Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP (Commercial)
QUALIFICATIONS
Position requires a Bachelor's degree in Chemistry, General Biological/Physical Science or related science from an accredited college or university with a minimum of 10 years of experience in Quality in the pharmaceutical industry.
Must have previous experience with Third party / supplier Quality.
Generic pharmaceutical industry experience is preferred.
Position requires a strong knowledge of cGMP and US FDA regulations.
Position requires the ability to work independently, and requires excellent skills in all areas of communication, collaboration, and decision-making.
GMP DECISION-MAKING AUTHORITY
The position has GMP decision making authority in the areas of product disposition and approval of Quality documentation.
We are an EEO employer, including disability & vets.
-
QA Food Safety Supervisor
4 weeks ago
Morristown, United States QUAD, a SolomonEdwards Company Full timeQA Food Safety Supervisor QUAD is seeking a QA Food Safety Supervisor for an exciting consumer product organization located in Morristown, NJ. The QA Supervisor will be responsible for supporting organizational food safety and quality assurance functions, including quality and reliability testing and implementation of policies and procedures....
-
Party Coordinator
2 weeks ago
Morristown, New Jersey, United States Lahn Hospitality and Amusement Group Full timeJob Title: Party CoordinatorWe are seeking a highly motivated and organized Party Coordinator to join our team at Lahn Hospitality and Amusement Group. As a Party Coordinator, you will be responsible for coordinating and executing all parties, managing contracts, and ensuring exceptional guest experiences.Key Responsibilities:Coordinate and execute all...
-
Quality Assurance Manager
2 days ago
Morristown, Tennessee, United States Alvogen Full timeJob SummaryThe QA Manager Operations, Third Party is responsible for providing quality and compliance oversight of third-party contractors and external partners for Alvogen Inc. in the U.S. market.Key ResponsibilitiesHandles day-to-day quality responsibilities for assigned products manufactured by third-party suppliers and distributed by Alvogen in the...
-
Survey Party Chief
4 months ago
Morristown, United States Spotlock Full timeJob DescriptionJob DescriptionAbout Us:We are a leading surveying and geospatial solutions provider dedicated to delivering accurate and reliable data to support various industries such as construction, land development, and infrastructure projects. We are committed to excellence in surveying services and are seeking a skilled and experienced Survey Party...
-
Morristown, New Jersey, United States Bayer Full timeAbout the RoleBayer is seeking a highly experienced Senior Manager to lead our Analytical Development Operations, Compliance, and Clinical Supplies team. As a key member of our organization, you will be responsible for managing all analytical activities for clinical trials and consumer studies, including product release and stability study management.Key...
-
Production Operator 3rd Shift Specialist
2 weeks ago
Morristown, Tennessee, United States Clayton Homes Full timeJob SummaryClayton Homes, a leading housing provider, is seeking a skilled Production Operator 3rd Shift to join our team. As a key member of our manufacturing team, you will be responsible for operating CNC and robotic equipment to produce high-quality interior doors.Key ResponsibilitiesOperate CNC and robotic equipment to produce interior doorsEnsure work...
-
Perfumer- 3rd Shift
5 days ago
Morristown, Tennessee, United States Givaudan Fragrances Full timeJob SummaryWe are seeking a skilled Compounder- 3rd Shift to join our team at Givaudan Fragrances. As a key member of our production team, you will be responsible for blending ingredients according to formulas provided, ensuring the highest quality and consistency of our products.Key ResponsibilitiesMixes materials according to formulas using heating and...
-
Extrusion Operator
4 weeks ago
Morristown, United States Double H Plastics Full timefalse false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 Position Purpose: Extrude and Finish Cores to customer specifications and functional requirements. Perform all work in safe manner following safety guidelines. Production is completed on all lines at Standard Rates. PRIMARY DUTIES AND RESPONSIBILITIES: Perform routine quality checks on all...
-
Office Manager
1 week ago
Morristown, Tennessee, United States ReVida Recovery Centers LLC Full timeJob SummaryWe are seeking a highly skilled and experienced Office Manager to join our team at ReVida Recovery Centers LLC. The successful candidate will be responsible for maintaining the smooth operation of our office functions, ensuring accuracy and timeliness of transactions, and providing exceptional customer service to our patients and staff.Key...
-
Survey Party Chief
3 weeks ago
Morristown, New Jersey, United States Spotlock Full timeJob DescriptionAbout Us:At Spotlock, we are a leading provider of geospatial solutions dedicated to delivering accurate and reliable data to support various industries such as construction, land development, and infrastructure projects. We are committed to excellence in surveying services and are seeking a skilled and experienced Survey Party Chief to join...
-
Perfumer- 3rd Shift
6 days ago
Morristown, Tennessee, United States Givaudan Fragrances Full timeJob SummaryWe are seeking a skilled Compounder- 3rd Shift to join our team at Givaudan Fragrances. As a key member of our production team, you will be responsible for blending ingredients according to formulas provided, ensuring the highest quality of our fragrances.Key ResponsibilitiesMixes materials according to formulas using heating and chilling...
-
Digital Content Manager
3 weeks ago
Morristown, United States Clark Davis Associates Full timeDigital Content ManagerFull TimeHybrid - Morristown, NJSalary range: $120-130K*Must be US Citizen or Green Card Holder. No C2C or visa sponsorship*Responsibilities:Lead and manage multiple digital omnichannel engagement projects across organizationResponsible for end-to-end content/digital development processInteract with multiple teams as well as external...
-
Digital Content Manager
2 weeks ago
Morristown, United States Clark Davis Associates Full timeDigital Content ManagerFull TimeHybrid - Morristown, NJSalary range: $120-130K*Must be US Citizen or Green Card Holder. No C2C or visa sponsorship*Responsibilities:Lead and manage multiple digital omnichannel engagement projects across organizationResponsible for end-to-end content/digital development processInteract with multiple teams as well as external...
-
Sr Business Systems Analyst
6 days ago
Morristown, United States Softworld Inc Full timeJob Title: Sr Business Systems Analyst Job Location: Morristown NJ 07960 Onsite Requirements: Experienced in the Property & Casualty space Strong Microsoft Excel skills. Job Description: Role: The Business Systems Analyst works very closely with all stakeholders including business customers, vendors, and internal resources in order to facilitate team...
-
Director Quality-Steriles
4 days ago
Morristown, United States Alvogen Full timeSUMMARY OF POSITION The Director, Quality- Steriles ensures quality and compliance of Sterile/Combo Products and Medical Devices. In this position, the Director develops strategic direction and provides the governance/oversight of this segment of products operations that comprise the Alvogen portfolio. The Director leads the team that directly interacts...
-
Tax Compliance Manager
2 months ago
Morristown, United States Bryce Poynt Consulting Full timeJob DescriptionJob DescriptionTax ComplianceReview all federal pro-forma tax returns in Corptax and all applicable supporting workpapers.Timely review of all federal forms/attachments for filing of the Avaya federal consolidation.E-file the Avaya federal consolidated tax return.Review of state/locality returns prepared by Avaya/3rd party resources.Review...
-
Tax Compliance Manager
3 weeks ago
Morristown, United States Bryce Poynt Consulting Full timeTax Compliance Review all federal proforma tax returns in Corptax and all applicable supporting workpapers.Timely review of all federal forms/attachments for filing of the Avaya federal consolidation.Efile the Avaya federal consolidated tax return.Review of state/locality returns prepared by Avaya/3rd party resources.Review quarterly federal & state...
-
Morristown, New Jersey, United States Smith Arnold Partners Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Product Development Manager/Product Owner to lead our technical operations team and drive the development of our Real Estate Right Of Way (ROW) SaaS software solutions. This is a high-visibility position that requires strong leadership and technical expertise to guide and grow our product...
-
Machine Operator
4 months ago
Morristown, United States Rich Products Full timeJob DescriptionJob DescriptionRich’s, also known as Rich Products Corporation, is a family-owned food company dedicated to inspiring possibilities. From cakes and icings to pizza, appetizers and specialty toppings, our products are used in homes, restaurants and bakeries around the world. Beyond great food, our customers also gain insights to help them...
-
Sr Business Systems Analyst
2 weeks ago
Morristown, United States Softworld, a Kelly Company Full timeJob Title: Sr Business Systems AnalystJob Location: Morristown NJ 07960Onsite Requirements:Experienced in the Property & Casualty spaceStrong Microsoft Excel skills.Job Description: Role:The Business Systems Analyst works very closely with all stakeholders including business customers, vendors, and internal resources in order to facilitate team communication...