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The Regulatory Affairs Specialist is responsible for preparing Nutritional Facts and Ingredient Statements (reg sheets) for all products within the Bimbo Bakeries USA (BBU) organization, including private label brands and foodservice.
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Job Title : EHS Specialist I. Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives.
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Completes hazard assessments, process hazard analysis, life safety reviews, assists in conducting incident investigations, environmental regulatory field analysis, environmental reports and permit applications.
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Our client, one of the largest Pharma companies in the U.S., is looking for an EHS Specialist - I (Assistant) in their West Point, PA Location Job Title: EHS Specialist - I (Assistant) Location: West Point, PA (Onsite) About the Role: Qualifications: Bachelor's Degree concentration in Safety or Environmental related technical discipline preferred.
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This position is responsible for accuracy in regard to billing and keeps abreast of all regulatory bodies regarding compliance issues and changes in addition to keeping current with all medical policies as they pertain to our practice.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance). The Global Labeling Therapeutic Area group is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country's Local Labeling.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Key Interactions: Internal Nature or purpose of interaction QC Change controls, CAPAs, investigations, calibrations Operations CAPAs, investigations QA team Change controls, CAPAs, investigations, calibrations, metrics, QTAs Technical Services Projects, protocols Research and Development New Products/projects Facility Customer and Regulatory Audits External System Implementation Partners Vendors Third Party Vendors Regulatory Agencies.
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The QC Data Entry Specialist ensures the accuracy and completeness of patient files by meticulously validating and entering data, utilizing the RealTime CTMS. This role requires a keen understanding of healthcare quality, regulatory standards, and medical terminology, although a clinical research background is not mandatory.
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Job Description: Responsible for independently coordinating all activities associated with timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies.
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The Quality Specialist assists with internal and external quality operations and systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance as applicable, and helps assure compliance with current domestic and international GMPs and regulatory agencies.
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Serves as the liaison with vendors and effectively manages vendor relationships related to cleaning and maintenance, office administration, audit, taxation, legal, regulatory, risk management, insurance, and cash management issues.
$75,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Quality Specialist may monitor, track and trend Non-Conformances, CAPA and other quality systems, assesses the risk level associated with Non-Conformances and escalate the issue to management.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance. The Quality Specialist, with guidance from the IPT Quality Lead, ensures product / process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system.
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Assure completion of all regulatory submissions, notifications, etc. Responsibilities:With management direction, responsible for supporting projects and programs to ensure compliance with environmental, health, and safety (EHS) programs through a role in Global Safety and the Environment at West Point site.
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regulatory specialist jobs in Lansdale, PA
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