Associate Director, Quality Assurance - Trenton, United States - J-STAR Research

J-STAR Research Trenton, United States

3 weeks ago

Description

Prerequisites

≥ 7 years of experience within the pharmaceutical/biotechnology industry or CDMO industry is required.

≥ 3 years of experience in small molecule cGMP processing, analysis and/or release testing is required.

≥ 3 years of experience in process chemistry is preferred, but not required.

BA/BS degree in chemistry, chemical engineering or pharmaceutical sciences is required.

Responsibilities

Support J-STAR's Quality System for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.

Maintain J-STAR's Quality System in a manner consistent with FDA/ICH requirements for cGMP manufacture and testing for APIs in early clinical phases.

Promote compliance with cGMP regulations. Present and coordinate GMP training sessions.

Support management and maintenance of the SOP and Document Control system.

Author, review, update, and approve quality documents, specifications, and procedures as needed.

Conduct timely review and approval of batch process and analytical records. Release APIs and intermediates manufactured subject to GMP compliance.

Provide guidance to GMP personnel and ensure that deviation and OOS investigations are adequate and completed in a timely manner.

Ensure that change control is enforced for critical systems, procedures, and specifications.

Audit and approve suppliers of materials and services critical to GMP activities.

Participate in internal audits to assess GMP compliance and identify potential gaps or training needs. Develop and implement corrective actions to address observations.

Act as secondary J-STAR contact for client audits and regulatory inspections. Track completion of post-audit action items.

Work with clients to develop material release tests and specifications for materials supplied by JSTAR.

Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, cGMP Operations and Quality Control.

Respond to client inquiries and provide information and updates as needed and appropriate to support regulatory filings.

Qualifications

Proven track record of setting and meeting aggressive targets and timely execution of objectives.

Excellent written, verbal and communication skills.

Ability to prioritize and manage numerous projects simultaneously.

Ability to interact in an effective and appropriate manner with diverse population sets.

Ability to communicate candidly, clearly and timely.

Experience in working on, positively contributing to, and leading teams.

Proficient in MicrosoftOfficeTMand other job-related software and applications.

Reporting Relationship

Reports to the Director of Quality Assurance

#J-18808-Ljbffr

Quality Assurance

4 weeks ago

Parkside Informationstechnologie Philadelphia, United States

Fur Software, die sich auf Dauer bewahrt Um zusatzliche Kosten zu vermeiden, den ROI zu erhohen und sicherzustellen, dass ein bestimmtes Softwareprodukt die Erwartungen vollstandig erfullt, ist es von entscheidender Bedeutung, einen klar definierten QA-Prozess zu haben und diesen ...
Quality Assurance Compliance Manager

2 weeks 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 Assurance Analyst

3 weeks ago

Dow Jones Princeton, United States

About us**: · Dow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile and live events. Dow Jones has produced unrivaled quality content for more t ...
Quality Assurance Analyst

2 weeks ago

Epsom Global Consulting Plainsboro, United States

**Job Overview**: · We are seeking a talented QA Analyst with expertise in Marketing Cloud softwares similar to Salesforce Marketing Cloud or Adobe Campaign to join our growing team. If you are passionate about quality assurance, have a keen eye for detail, and possess strong ski ...
Quality Assurance Coordinator

1 week ago

APluscare LLC East Brunswick, United States

Come work for a great company at APluscare · The Quality assurance Coordinator is responsible for preserving the standard of the services of the agency. Quality assurance personnel are accountable for assisting to create and execute quality control and management methods and syst ...
Director of Quality Assurance

3 weeks ago

Basil Consulting Group Warrington, United States

**TITLE**: Director of Quality Assurance · **TYPE**: Direct Hire · **LOCATION**:Warrington, PA · **ONSITE/REMOTE/HYBRID**: Onsite · **START DATE**: April 2024 · **SHIFT**: Day · We are a growing company looking for a Director of Quality Assurance. This role will be hands-on and o ...
Quality Assurance Specialist

1 week ago

APluscare LLC East Brunswick, United States

The Quality Assurance Specialist will complete audits in the residential programs to ensure accuracy and compliance with DDD standards and regulations. This shall include monitoring of fiscal, medical and ISP documentation to ensure accuracy. The Quality Assurance Specialist will ...
Quality Assurance Specialist

1 week ago

Datwyler Pharma Packaging USA, Inc Pennsauken, United States

**Position Summary** · The Quality Assurance Specialist handles the quality requirements and standards for manufacturing products in a GMP-regulated environment. Being a hands-on person, the incumbent of this position will support the site quality system and procedures in alignme ...
Quality Assurance Manager

2 weeks ago

Star Labs Piscataway, United States

Founded 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 Assurance Specialist

2 weeks ago

Dätwyler Pennsauken, United States

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive globa ...
Quality Assurance Coordinator

2 weeks ago

RWJBarnabas Health New Brunswick, United States

**Job Overview**: · Quality Assurance Coordinator will be responsible for working on the assembly line, accurately assembling and checking patient meal trays. Will also be responsible for making thickened nutrition supplements and formula. Must have excellent communication skills ...
Quality Assurance Manager

2 weeks ago

Extremity Care Conshohocken, United States

**Purpose**: · The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. · **Duties & Responsibilities**: · - Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriat ...
Quality Assurance Manager

1 week ago

DIGI AMERICA INC Trenton, United States

Overview · At DIGI we are always Searching for a New Balance. Our vision is to create new standards. · Using original technology, we create new standards for the market - and when these new standards become commonplace, we break with convention and take on the challenge of creati ...
Quality Assurance Manager

3 weeks ago

Direct Sales Recruiting LLC Trenton, United States

Quality Assurance Manager - Manufacturing · My client is an innovative company that manufactures and develops metal and plastic solutions for a variety of industries. They are seeking to hire a Quality Assurance Manager responsible for managing all aspects of the quality system, ...
Quality Assurance Manager

5 days ago

Clinical Dynamix Trenton, United States

Quality Assurance Manager · Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding · Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization. · M ...
Quality Assurance Manager

1 week ago

TCG GreenChem Inc. Trenton, United States

Leadership responsibility to manage quality assurance and compliance programs and business excellence efforts at TCG GreenChem. Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate development requirements in drug substance development pr ...
Quality Assurance Manager

6 days ago

X4 Life Sciences Trenton, United States

There is an exciting opportunity for a Quality Assurance Manager for a boutique Clinical Trial sourcing Pharmaceutical company based in New Jersey · The successful candidate must have a strong background in secondary Pharmaceutical packaging & labelling. · Experience within cli ...
Director, Quality Assurance

3 weeks ago

Perspective Therapeutics Trenton, United States

The Director, Quality Assurance oversees Perspective Therapeutics' (PTX) Somerset, New Jersey Quality Management System (QMS) and ensures that the system and Somerset site operation are compliant with applicable regulations, standards and company requirements. This leader provide ...
Director, Quality Assurance

3 weeks ago

Perspective Therapeutics, Inc Trenton, United States

The Director, Quality Assurance oversees Perspective Therapeutics' (PTX) Somerset, New Jersey Quality Management System (QMS) and ensures that the system and Somerset site operation are compliant with applicable regulations, standards and company requirements. This leader provide ...
Quality Assurance Associate

2 weeks ago

CORA Services Inc Philadelphia, United States

**DUTIES AND RESPONSIBILITIES**: · - Assist IBHS and ABA Staff with facilitation of IBHS and ABA service delivery to clients through administrative support. · - Maintain service-related documentation in client records by collecting and entering client service data in internal and ...