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The Plasma Center Specialist ensures donor suitability, product integrity and the continued good health of donors through the compliance with Food and Drug Administration (FDA) regulations, state regulations, and the Standard Operating Procedure (SOP) Manual guidelines and any other applicable regulatory standards.
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Computer Systems Validation Specialist. With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide.
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Certification or eligibility as Medical Laboratory Scientist (MLS) or Specialist certification through American Society of Clinical Pathology (ASCP) or equivalent preferred. Coordinates quality improvement and assurance activities in the Blood Bank to ensure safe patient care, compliance with internal policies and procedures, and external (FDA, CAP/AABB, Joint Commission, FACT, NJDOH) regulatory compliance.
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Aramark Workplace Experience Group is currently seeking a Senior Safety Specialist (Regional Safety Manager) to join the National Account Team. The Senior Safety Specialist (Regional Safety Manager) will coordinate efforts targeting a holistic approach to assist the organization with implementation of safety and risk programs, processes, and procedures to protect people, property, environment, and company assets.
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All work must be performed within the USA. The Sr Specialist Proposal Writer is expected to execute responsibilities independently with oversight of writing product and content creation as needed.
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The Facilities Specialist will troubleshoot, repair and maintain facilities that includes infrastructure, utilities and equipment while ensuring the systems' safety, compliance and cGMP regulatory when applicable.
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Ensures the completion regulatory PM program critical instrumentation and safety set points involved with Control Room and Terminal Operations. The MIPC I&E Specialist performs installation, maintenance, calibration, troubleshooting, repairs, and system development for all pipeline and terminal assets including motor controls, distributive controls, PLC's, communications systems, and technical issues that may arise.
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The QA Specialist role is responsible for maintaining the License to Operate (LTO) for products and processes manufactured at the facility; including interpretation of internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product.
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Working under the direction of a licensed pharmacist, participates in the preparation, dispensing, distribution and return of patient specific medications including intravenous admixtures, supplies and maintains automated technology equipment, packages unit of use dosages, maintains and transports pharmaceuticals, and performs tasks associated with regulatory compliance.
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Supervises the LPN every 30-days and supervises the HHA/CNA every 14-days (or per regulatory requirements) and teaches other nursing personnel. Schedules specialist and other appointments for participants and assists in hospital admissions.
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The Compliance Associate will be part of the Core Compliance team and will work under the general direction of the Senior Compliance Manager to support the policy governance, compliance monitoring and testing, compliance education, and regulatory change management programs.
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Partner with Program Specialist to ensure that all monthly/quarterly/annual documentation is maintain in accordance with programmatic and regulatory requirements. Supervise daily operations and ensure compliance with internal/external regulatory, policy and procedural requirements.
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Familiarity with Building Management Systems (BMS) and Computerized Maintenance Management Systems (CMMS). Previous experience servicing and maintaining building/facilities and process equipment and performing calibration checks on critical utility systems and process equipment.
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Macquarie is a global financial group providing clients with asset management, retail and business banking, wealth management, leasing and asset financing, market access, commodity trading, renewables development, specialist advisory, capital raising and principal investment.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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regulatory specialist jobs in Lansdowne, PA
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