Trabajos fda regulatory en Nutley, New Jersey (NJ) State

Ensure that all Clinical Trials under their supervision are carried out as per FDA, Regulatory Authorities and Sponsor requirements. Delegate and oversee that Study Supervisors/Research-Assistants ...

Be ready to pass any FSQ, USDA, and FDA regulatory audit. * • Ensure the dish machine is manned properly meets expected throughput and is staged in the proper location. * Communicates with shifts ...

Conduct quality checks on production output to ensure compliance with FDA regulations and internal quality standards. * Complete forms required by Standard Operating Procedures (SOPs), Checklists ...

Strong knowledge of FDA regulatory and fraud and abuse law. * Ability to learn quickly and operate in a fast paced, matrixed environment * Able to participate on key teams and/or be involved in key ...

Strong knowledge of GCPs, ICH guidelines and FDA regulations related to Clinical Research, and experience in Clinical Quality Assurance. * Working knowledge of the drug development process, GLPs, and ...

... FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system ...

Initiate new egg donor and gestational carrier consultations; complete full work up IAW FDA regulations. * Develop and implement patient management plans and collaborate with the physician team to ...

FDA, EPA, OSHA, ISO 13485:2003, COSMOS/ECOCERT, etc). * Responsible for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc), under ...

... FDA regulated environment. * Experience with HPLC, GC, etc., sample preparation and testing. * Knowledge of USP Monograph testing, method development & validation. * Knowledge of CFR & ICH Regulatory ...

Ensure compliance with global GMP guidelines and regulatory requirements, defined by FDA, EMA, and other global health authorities, for CMC activities. Provide CDMO oversight through batch record ...

Maintain the quality management system to meet cGMP and regulatory requirements. * Maintain all quality system documentation in accordance with cGMP guidelines. * Responsible for leading FDA ...

Maintain partnerships with EM sites in combination with the Quality & Regulatory Director. * Draft ... Understanding of GxPs and FDA Compliance requirements. * Excellent communication skills, including ...

Regulatory experience with the Consumer Product Safety Commission (CPSC) or the Food and Drug Administration (FDA) is a significant advantage. This position is vital to our succession planning, as ...

... regulations including, but not limited to, those issued by the Department of Transportation (DOT), Federal Motor Carrier Safety Administration (FMCSA), Food & Drug Administration (FDA), and the ...

Regulatory Compliance: * Stay informed about vaccine-related regulations, guidelines, and recommendations issued by regulatory agencies such as the CDC, FDA, and state health departments. * Ensure ...

Directly involved with on-site regulatory (FDA, NJ-DHHS, etc.) inspections as well as internal and third-party audits and writing and overseeing responses to audits to comply with cGMP and GLP

Prepare Clinical Pharmacology components of regulatory submissions and represent the Clinical ... Strong knowledge of clinical drug development and FDA and ICH guidance documents is essential

... regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management: • Documentation ...

Ensure that all products meet quality and safety standards set by regulatory bodies such as the FDA, USDA, and GMP. * Manage and execute product testing, shelf-life testing, and sensory testing

... regulatory bodies, food certification requirements and company standards. This individual will be ... GFSI FDA and/or USDA regulated facility. * SQF Practitioner, HACCP, and PCQI certification is ...

Maintains regulatory binders in accordance with FDA guidelines * Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs

... regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and ...

... regulatory submission challenges. Strong industry experience, technology-enabled services, and a ... Familiarity with 21 CFR Part 11, FDA, and GCP requirements. * Basic understanding of CROs and ...

Must have knowledge of Good Clinical Practice, FDA and HIPAA regulations, and product safety testing. COMMUNICATION SKILLS * Must have strong communication and interpersonal skills. OTHER KNOWLEDGE ...