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Datafielder
New York, NY, United States
Sr. Quality Assurance Engineer DataFielder Inc - New York, NY Tagged: Generative AI, Quality Assurance, Multi-Cloud DataFielder is a woman-minority owned (MBE) staffing and consulting services agency. Our mission is to provide organizations with exceptional talent while advocating for diverse and underrepresented groups through data-driven insi
Job Source: DatafielderInfinity Laboratories
North Brunswick Township, NJ, United States
Quality Assurance Manager Must have: Bachelor's degree (B.S/B.A.) or higher in microbiology, chemistry, or related fields. 5 years of relevant laboratory quality assurance experience. 2 years of experience in a quality management position overseeing quality assurance and quality control activities. Able to successfully Pass Background and Drug Scr
Job Source: Infinity LaboratoriesInvitae Co.
Iselin, NJ, United States
As the Quality Assurance Manager, you will be responsible for clinical quality of laboratory operations. Working closely with the Director, Quality Assurance & Regulatory Affairs, you will provide quality oversight for development and commercial services. Location: Metropark, NJ, this is a hybrid position requiring 3 days onsite. What you'll do:
Job Source: Invitae Co.Equus
Union, NJ, United States
Job Description Manage and update internal tracking systems Review case files to ensure compliance with contractual agreements Conduct file and system maintenance reviews for all Workforce Innovation and Opportunity Act programs Assist with the development, implementation and enforcement of quality assurance plans Recommend corrective actions;
Job Source: EquusInvitae
Iselin, NJ, United States
Invitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and
Job Source: InvitaeJohnson ReSource Group
Bridgewater Township, NJ, United States
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. Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good Distribution Pract
Job Source: Johnson ReSource GroupSchreiner Group
, NY, United States
Schreiner Group LP has a full-time regular position for a Quality Assurance Manager. RESPONSIBILITIES: · Coaches, mentors, and leads all employees in the Quality Assurance Manager’s areas of responsibility to achieve goals and objectives related to quality control, quality assurance, customer demands, and customer specifications. · Drives quality
Job Source: Schreiner GroupBrown Brothers Harriman & Co.
Jersey City, NJ, United States
At BBH we value diverse backgrounds, so if your experience looks a little different from what we've outlined and you think you can bring value to the role, we will still welcome your application! What You Can Expect At BBH: If you join BBH you will find a collaborative environment that enables you to step outside your role to add value wherever y
Job Source: Brown Brothers Harriman & Co.Cranford, NJ, United States
Proclinical are seeking a Senior Manager, Quality Assurance responsible for in-house and outsourced activities supporting our GMP viral vector drug substance manufacturing and testing facility.
Responsibilities:
Provide support for the transition from phase-appropriate to commercial expectations for site-related GMP activities
Perform equipment, utility, and facility qualification/validation protocol review and approval including both pre and post execution. Support closure of exceptions and approval of final reports.
Perform product release activities, including reviews of batch records, and other documentation for product release/disposition.
Assess and approve analytical related documents, including validation protocols/reports, stability, shelf-life extension, drug substance and drug product testing data and OOS
Assess change controls for risks and impact on processes, product, and programs
Pro-actively identify and escalate business-critical issues affecting Compliance, Operations, and Quality Assurance
Review raw data and data summaries presented in internal reports and regulatory submissions
Work with subject matter experts to define and implement process and procedure improvements
Review and approve SOP's, specifications, and other controlled documents
Provide support with tracking and trending deviations, corrective actions, and process data
Provide support to ensure audit observations, changes, and corrective actions are addressed and closed in a timely manner
Provide support for reviews of product and program risk, working with subject matter experts and key stakeholders to ensure communication and timely follow-up of mitigation activities
Provide support with coordination and execute quality assurance activities during technology transfer projects
Requirements:
BS degree (minimum) in biological sciences or related field of study. Advance degree is a plus
8+ years of relevant experience in biological sciences or biotechnology within quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations.
6 + years of experience with Masters degree in biological sciences or biotechnology
Preference given to candidates with +3 years of cell and gene therapy experience, in manufacturing, Quality Control or Quality Assurance
Hands-on experience in the interpretation and application of cell and gene therapy regulations and guidance documents
Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP/GLP/GCP regulations.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at [email protected]
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Email Alert for Sr. Manager, Quality Assurance jobs in Cranford, NJ, United States
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