Quality Assurance Manager
2 weeks ago
Breckenridge Pharmaceutical Inc. is dedicated to the development and marketing of high-quality, value-added, and cost-efficient generic medications in the United States. Our products are innovatively developed within our own research and development facilities and through strategic collaborations with manufacturers globally.
This role reports directly to the Associate Vice President of Quality Assurance and encompasses the management and support of various critical functions: ensuring compliance with current Good Manufacturing Practices (cGMP) for contract manufacturers, overseeing the company's Standard Operating Procedures (SOP) and Training systems, administering the QA/QC Testing and Audit program, and making Quality and Compliance decisions related to the Company's Abbreviated New Drug Application (ANDA) products, as well as those adhering to Over-the-Counter (OTC) Monographs and FDA or other industry-recognized standards for Dietary Supplements and Medical Foods.
Key Responsibilities:
- Conduct, support, and assess third-party audits of existing and prospective vendors for cGMP compliance.
- Oversee the SOP system, which includes drafting, revising, and maintaining SOPs, along with managing SOP Tracking and Training.
- Facilitate the market distribution of product batches.
- Manage the review and resolution of batch deviations, Out-of-Specification (OOS) reports, and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical Foods.
- Address product quality complaints effectively.
- Assist with FDA audits and inspections of the company or its manufacturing partners as necessary.
- Conduct Product Quality Reviews, including the evaluation of manufacturers' annual product review reports.
- Oversee change control reviews for Dietary Supplements and Medical Foods products.
- Review batch records as required.
Essential Qualifications, Education, and Experience:
- Bachelor's degree required (preferably in a technical or scientific field such as biology, chemistry, pharmacy, or another relevant science/technology).
- A minimum of 7 years of experience in the pharmaceutical sector, with a focus on Quality Assurance and Quality Systems (preferably with at least 2 years in a management role within QA).
- Willingness to travel domestically to contract manufacturing sites, with potential for international travel for audits.
-
Quality Assurance Manager
1 week ago
Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full timeJob OverviewBreckenridge Pharmaceutical Inc. is dedicated to the development and marketing of high-quality, value-added, and cost-efficient generic medications in the United States. Our products are crafted in-house through our R&D facilities and in collaboration with global manufacturing partners.This role reports directly to the Associate Vice President of...
-
Quality Assurance Manager
2 weeks ago
Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full timePosition OverviewBreckenridge Pharmaceutical Inc. is dedicated to the development and marketing of high-quality, value-added, and cost-efficient generic medications within the United States. Our products are innovatively crafted in our in-house R&D facilities and through strategic collaborations with manufacturers globally.This role reports directly to the...
-
Quality Assurance Lead
2 weeks ago
Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Full timeBreckenridge Pharmaceutical is seeking a dedicated professional for the role of Quality Assurance Manager.This position will report directly to the Associate VP of Quality Assurance and will be responsible for overseeing compliance assessments in accordance with current Good Manufacturing Practices (cGMP), managing standard operating procedures (SOP), and...
-
Quality Assurance Lead
2 weeks ago
Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Full timeBreckenridge Pharmaceutical is seeking a dedicated professional to oversee quality assurance operations within our organization.This role, reporting directly to the Associate VP of Quality Assurance, is pivotal in ensuring compliance with current Good Manufacturing Practices (cGMP), managing standard operating procedures (SOPs), and overseeing quality...
-
Quality Assurance Lead
2 weeks ago
Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Full timeBreckenridge Pharmaceutical is seeking a dedicated professional for the role of Quality Assurance Manager.This position is responsible for overseeing compliance with current Good Manufacturing Practices (cGMP), managing standard operating procedures (SOPs), and ensuring quality assurance and quality control testing.KEY RESPONSIBILITIES:Perform audits to...
-
Quality Assurance Specialist
1 day ago
Berkeley Heights, New Jersey, United States VySystems Full timeJob Title: Quality Assurance AnalystAbout the Role:We are seeking a highly skilled Quality Assurance Analyst to join our team at VySystems. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality of our software products and services.Key Responsibilities:Design and execute test plans to ensure the quality of our software...
-
Quality Assurance Automation Engineer
2 weeks ago
Berkeley Heights, New Jersey, United States Diverse Lynx Full timePosition: Quality Assurance Automation Engineer (Expertise in Playwright or Cypress, TOSCA, BDD) Overview: We are seeking a dedicated Quality Assurance Automation Engineer to join our team. The ideal candidate will possess a robust set of skills and experience in the following areas: Proficient in JIRA, Test, Postman, and SQL Experience with Mainframe...
-
Quality Assurance Automation Engineer
1 week ago
Berkeley Heights, New Jersey, United States enexusglobal Full timeJob OverviewWe are seeking a Quality Assurance Automation Engineer with expertise in TOSCA and Cypress to join our dynamic team. This role requires a strong foundation in automation testing methodologies and a commitment to delivering high-quality software solutions.Key Skills Required:Proficient in JIRA, Test, Postman, and SQL.Experience working with...
-
Software Quality Assurance Specialist
2 weeks ago
Berkeley Heights, New Jersey, United States Insight Global Full timePosition OverviewWe are in search of a dedicated and proficient Full Stack Quality Assurance Engineer to enhance our quality assurance team. In this role, you will be instrumental in validating the quality and dependability of our software solutions. Your responsibilities will encompass testing both the front-end and back-end systems, adhering to Agile...
-
Software Quality Assurance Specialist I
2 weeks ago
Berkeley Heights, New Jersey, United States SAMSUNG Full timePosition Overview The Software Quality Assurance Professional will take a proactive role in providing insights and support to the Quality Assurance team regarding their designated responsibilities. This individual will possess leadership skills to manage multiple intricate projects effectively. Responsibilities include designing, implementing, and...
-
Software Quality Assurance Specialist I
2 weeks ago
Berkeley Heights, New Jersey, United States SAMSUNG Full timePosition Overview The Software Quality Assurance Specialist I will engage in hands-on activities and serve as a vital information resource regarding designated responsibilities to fellow Quality Assurance personnel. This role requires leadership skills for managing multiple intricate projects. The individual will be responsible for designing, implementing,...
-
**Quality Assurance Automation Specialist**
1 week ago
Berkeley Heights, New Jersey, United States 10bits Full timeAbout 10bits10bits is a leading provider of healthcare and professional staffing solutions. Our company specializes in delivering high-quality clinical professionals to hospitals and medical facilities, ensuring compliance with the highest standards of medical care.Job SummaryWe are seeking a highly skilled **Quality Assurance Automation Specialist** to join...
-
Software Quality Assurance Specialist I
1 week ago
Berkeley Heights, New Jersey, United States SAMSUNG Full timePosition Overview The Software Quality Assurance Professional will engage in hands-on activities and serve as a key information resource regarding designated responsibilities to fellow Quality Assurance personnel. This role demands leadership capabilities across multiple intricate projects. The individual will be tasked with designing, implementing,...
-
Lead Software Quality Assurance Professional
5 days ago
Berkeley Heights, New Jersey, United States SAMSUNG Full timeJob SummaryThe Professional I, Software Quality Assurance Specialist will be a hands-on and information resource about assigned areas of responsibility to other Quality Assurance staff and possess leadership capabilities for multiple complex projects. This role will design, implement, maintain and recommend changes about the new functions and features to...
-
Quality Assurance Automation Specialist
2 weeks ago
Berkeley Heights, New Jersey, United States Crescens Full timePosition: Quality Assurance Automation Specialist Location: Remote Contract Duration: 6 months + Role Overview: Utilize your expertise in business, functional, and technical domains to effectively devise and implement testing strategies and planning initiatives. Collaborate with various programs and systems on projects of moderate complexity, contributing as...
-
Software Quality Assurance Specialist
2 weeks ago
Berkeley Heights, New Jersey, United States Insight Global Full timeJob OverviewWe are in search of a dedicated and proficient Full Stack QA Engineer to enhance our quality assurance team. In this role, you will be instrumental in guaranteeing the excellence and dependability of our software solutions. Your responsibilities will encompass testing both the front-end and back-end systems, adhering to Agile practices and...
-
Full Stack QA Engineer
1 week ago
Berkeley Heights, New Jersey, United States Talent Software Services, Inc. Full timeJob SummaryTalent Software Services, Inc. is seeking a highly skilled and motivated Full Stack QA Engineer to join our team in a contract to hire position. As a Full Stack QA Engineer, you will play a crucial role in ensuring the quality and reliability of our software applications.Key ResponsibilitiesCollaboration and CommunicationWork closely with...
-
Quality Assurance Engineer for Suppliers
2 weeks ago
Elmira Heights, New York, United States System One Full timePosition Title: Quality Assurance Engineer for SuppliersLocation: Elmira, NYEmployment Type: Full Time / On-siteRole Overview: The Quality Assurance Engineer plays a pivotal role in ensuring operational excellence at supplier facilities. This position requires a keen ability to identify challenges and implement effective solutions while demonstrating strong...
-
Quality Assurance Special Processes Lead
2 weeks ago
Elmira Heights, New York, United States System One Full timeEmployment Type: Full Time/On-site Role Summary: The Quality Assurance Special Processes Lead is responsible for coordinating special processes and ensuring that the internal standards of the organization are adhered to for compliance. Special processes refer to those procedures that cannot be completely verified for compliance upon completion, meaning that...
-
Quality Assurance Specialist
2 days ago
Plandome Heights, New York, United States SilverWorks Full timeWe are seeking a skilled Quality Technician to support our team at SilverWorks in the field of quality management. In this role, you will play a crucial part in ensuring and improving product quality according to the highest standards of the industry.Key Responsibilities:Conduct thorough quality inspections, analyses, and evaluations to guarantee product...