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Manager in Training
1 week ago
LA Fitness South Plainfield, United States**About us** · Fitness Membership Consultant · LA|FITNESS is in search of some H.E.A.T.; Honest - Enthusiastic - Achievement Oriented - Team Players · Responsibilities and Duties · - Meet productivity goals through "VCLASS" to achieve weekly, monthly and yearly objectives. · - Ac ...
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Business Office Manager
1 week ago
AristaCare Cedar Oaks South Plainfield, United States**Business Office Manager (Full Time)** · Business Office Manager - is responsible for admitting and registration, patient billing and collection, third-party payer relations, and/or preparation of insurance claims. May also be responsible for the patient admitting function, gene ...
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Clinical Data Management
1 week ago
Katalyst Healthcares & Life Sciences South Plainfield, United States**Roles & Responsibilities**: · - Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies · - Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules · - Ensure proper completion of QC and UAT of EDC t ...
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Commercial Excellence Manager
5 days ago
Brenntag South Plainfield, United States**COMMERCIAL EXCELLENCE MANAGER - PHARMA**: · Our team in **South Plainfield** currently has an opening for a **Commercial Excellence Manager - Pharma** · **YOUR ROLE & RESPONSIBILITIES**: · **Job Summary**: · Commercial Excellence department at Brenntag Specialties is looking fo ...
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Assistant Project Manager
2 days ago
The Carian Group South Plainfield, United States**Location**:New Jersey (onsite)** · CARIAN is growing We are a proud, woman-owned management consulting firm providing program/project management, capital project delivery, consulting, and technology solutions to our customers in the renewable energy, power utilities, infrastruc ...
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Living area management
1 week ago
BlueNova Industries South Plainfield, United StatesDo you love being able to help people in your nursing profession and value the joy of work? · ▸ If respectful interaction in the workplace is important to you · ▸ If you are looking for a strong team and a good working atmosphere · ▸ If appreciation and recognition motivate you · ...
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Property Manager/project Manager
3 days ago
Pentaurus LLC Plainfield, United States_**Property Manager/Project Manager Job Description**:_ · We are looking to hire a self-starting, hard-working Property Manager/Project Manager to manage the day-to-day property management projects and operations with our maintenance team. This position will report directly to th ...
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Field Manager
1 day ago
Big Tent Coalition Plainfield, United States**About us** · BTC is revolutionizing the political landscape of Illinois through an innovative blend of old-school campaigning tactics and new-school data-driven strategies. Amidst a political climate lacking checks and balances due to party supermajorities, BTC is committed to ...
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General Manager
5 days ago
Wendy's Plainfield, United States**General Manager** · Want to make a difference? Want to be a leader? · We offer more opportunities for people to find the challenges they want and the recognition they deserve. We are seeking career minded motivated individuals with excellent interpersonal skills, and the abilit ...
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Finance Manager
1 week ago
Diageo Plainfield, United StatesJob Description: · Which company will you join? · From Arthur Guinness to Johnnie Walker, our business was founded on people of outstanding character, and in 250 years, nothing has changed. We're the world's leading premium alcohol company Our brands are industry icons including ...
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Parts Manager
3 days ago
Gerber Payroll Services, Inc. Plainfield, United States**Company: Gerber Collision & Glass** · **WELCOME TO GERBER COLLISION & GLASS** · **_Our Team Members Drive Us _**Gerber Collision & Glass is one of the largest collision repair companies in North America. With $2+ billion in sales, over 800 locations and growing, our 10,000+ tea ...
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Manager in Training
1 week ago
LA Fitness Plainfield, United States**About us** · Fitness Membership Consultant · LA|FITNESS is in search of some H.E.A.T.; Honest - Enthusiastic - Achievement Oriented - Team Players · Responsibilities and Duties · - Meet productivity goals through "VCLASS" to achieve weekly, monthly and yearly objectives. · - Ac ...
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Manager, Revenue
1 week ago
Hackensack Meridian Health Edison, United StatesOverview: · Our team members are the heart of what makes us better. · At **Hackensack Meridian **_Health_** we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team member ...
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Field Manager
1 week ago
EcoShield Pest Solutions Edison, United StatesOverview: · The Shield Co. Management / EcoShield Pest Solutions is one of the fastest growing pest control companies in the country Simply stated, we provide comprehensive solutions for pest-free living, but our purpose is to spread happiness. We accomplish that by delivering ab ...
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Service Manager
1 week ago
EcoShield Pest Solutions Edison, United StatesOverview: · The Shield Co. Management / EcoShield Pest Solutions is one of the fastest growing pest control companies in the country Simply stated, we provide comprehensive solutions for pest-free living, but our purpose is to spread happiness. We accomplish that by delivering ab ...
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Account Manager
1 day ago
Concordance Healthcare Solutions, LLC Edison, United StatesAt** Concordance Healthcare Solutions**, we believe that each team member makes a difference in driving our purpose of positively impacting lives forward. Concordance is committed to our guiding principles of financial stewardship, accountability, forward thinking, aligned relati ...
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Manager in Training
1 week ago
LA Fitness Edison, United States**About us** · Fitness Membership Consultant · LA|FITNESS is in search of some H.E.A.T.; Honest - Enthusiastic - Achievement Oriented - Team Players · Responsibilities and Duties · - Meet productivity goals through "VCLASS" to achieve weekly, monthly and yearly objectives. · - Ac ...
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General Manager
1 week ago
Playa Bowls Edison, United States**Who We Are**: Playa Bowls is New Jerseys Original Acai Shop, and our mission is to serve the highest quality, innovative products to support healthier lifestyles and inspire a world of fun, excitement, and togetherness. At Playa Bowls, we live our brand in our actions and in th ...
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Assistant Store Manager
1 week ago
Extra Space Management, Inc Metuchen, United StatesAs an **Assistant Store Manager**, you will have the opportunity to be part of a diverse team with an excellent company culture. We offer **competitive wages**, a **great work/life balance**, and **career and development opportunities**. · Extra Space Storage is the **largest** s ...
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Practice Manager of Operations
1 day ago
Boulevard Place Dental Care Plainfield, United States**Practice Manager of Operations** · **Boulevard Place Dental Care in Plainfield, Illinois **is looking for a Practice Manager of Operations to join our team. · **Why Heartland Dental?** · Heartland Dental believes that to provide exceptional lifetime care for our patients, we mu ...
QA Manager - South Plainfield, United States - Kashiv BioSciences LLC
Description
Job Type Full-timeDescriptionPosition Summary The Quality Assurance Manager is responsible for maintenance of Kashiv's quality management system. This role will oversee and direct the activities of the QA organization.The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and QMS systems such as Deviations, CAPAs, and Change Controls.
This person will be responsible for ensuring that manufacturing operations have appropriate QA oversight, including identification and management of Nonconformance, Investigations, and Deviations.
The QA leader will be expected to drive continuous improvement initiatives and be capable of assessing and improving existing systems.
A demonstrated ability to successfully mentor staff and collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required.
The incumbent will be responsible for all functions of the Quality Assurance team, including providing guidance in support of both late-stage clinical and commercial biosimilar products and small molecule in cGMP-compliant laboratories and the manufacturing operation.
Essential Duties & Responsibilities Oversee thorough and compliant investigations, including Deviations and CAPAs. Develop, initiate, manage and implement improvements to quality systems and processes.Ensure that all operations are compliant with cGMPs regulatory requirements.
Write, review and approve SOP system documents to ensure cGMP compliance, as required.
Oversee review and approval raw materials and components, manufacturing documents, including standard formula, test analyses, batch production records and batch packaging records for release.
Oversee review and approve quality control documents, including quality specifications and testing standards.Supervises and directs the activities of QA staff.
Monitors effectiveness of Quality Systems, developing event metrics such as number and type of batch record errors, training deviations, etc., and trend analysis for management review, escalates issues and drives resolution.
Conduct qualification audits on vendor / supplier.Participates in deviations and OOS result investigations.
Ensure proper root-cause analysis and implement corrective and preventive actions.
Planning and implementation of Quality Review Board meetings.
Interface with all levels of Kashiv team to resolve issues.
Performs other functions as required or assigned.
Complies with all company policies and standards. Requirements Bachelor or Master degree in Life Science or other related discipline.
Minimum of 10 years of relevant experience in pharmaceutical quality assurance/control environment.
Minimum of 3 years in a direct supervisory role.
Experience of GMP document review, Quality Management System maintenance, quality auditing.
Understand the requirements and procedures related to document control and quality assurance.
