- Integra LifeSciences (Braintree, MA)
- …Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations. ... possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level...advertising material for adherence to approved product claims and regulatory compliance . + Work in partnership with… more
- Prime Therapeutics (Providence, RI)
- …Office Suite **Preferred Qualifications** + Health insurance/PBM operations and/or regulatory compliance audit experience + Project management experience + ... and drives every decision we make. **Job Posting Title** Regulatory Audit Specialist Sr. - Remote **Job... reviews and analysis of audit deliverables to ensure compliance with contractual and regulatory requirements. +… more
- Astellas Pharma (Westborough, MA)
- **QA Compliance Specialist ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... AIRM is headquartered in Massachusetts. Astellas is announcing a **QA Compliance Specialist ** opportunity at their **Astellas Institute for Regenerative… more
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. The Senior Quality Compliance Specialist has responsibility for supporting overall site ... Quality Management System (QMS) compliance . The Senior Specialist is a seasoned...external audits (eg, Notified Bodies and FDA). + Exceptional quality system and regulatory documentation writing and… more
- Sanofi Group (Framingham, MA)
- …diseases and bring hope to patients and their families. Your job, as Principal Compliance Specialist on our Quality Assurance (QA) Operations team will ... of operations at Sanofi's Framingham Biologics facilities. The Principal Compliance Specialist is responsible for providing quality support and guidance to… more
- Astellas Pharma (Westborough, MA)
- …to standards set forth by Quality Assurance, internal clients, and global regulatory bodies. The Validation Specialist will ensure that all critical GMP ... **Validation Specialist , Quality Assurance** Do you want... regulatory guidelines. The successful candidate will foster compliance across a broad range of Quality … more
- Sanofi Group (Northborough, MA)
- **Job Title:** Compliance Specialist Principal **Location** : Northborough, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every ... working independently with little to no supervision and in compliance with cGMPs to support Label and Packaging operations...as needed + Participate in specialized projects both within Quality and cross-functionally + Perform all aspects of … more
- SitusAMC (Providence, RI)
- …or counter-parties place of business. SQC reviews are performed to determine compliance with Investor and Regulatory servicing guidelines, including FHA, FNMA, ... but act local - come join our team! This role includes Servicing Quality Control (SQC) activities will include (i) the identification of the proper documentation… more
- CSL Plasma (Johnston, RI)
- …role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... quality requirements for business operations. + Reporting ...of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure… more
- Kelly Services (Boston, MA)
- …and procedures. + Collaborate with cross-functional teams to ensure compliance with regulatory standards. + Analyze quality data and trends to identify areas ... Kelly Science is seeking a Quality Assurance Specialist to join a...the biotechnology or pharmaceutical industry. + Strong knowledge of regulatory requirements and industry standards (eg, FDA, GMP). As… more
- PCI Pharma Services (Bridgewater, MA)
- …of PCI. Responsible for the daily maintenance and oversight of the Electronic Quality Management System (eQMS) for the Clinical Quality group, ensuring timely ... Responsible for ensuring CAPA's effectiveness and timeliness. Maintains required Quality Metrics (Documents, Investigations, and CAPA's) on a routine basis.… more
- Dentsply Sirona (Waltham, MA)
- …delivery of the safest and highest quality products while maintaining full regulatory compliance . The Complaint System Specialist will ensure that the ... Waltham, MA, is looking for someone to join our Quality team as a Product Complaint Specialist ....needed. + Reviews potential reportable events to determine if regulatory filings are required. + Ensures compliance … more
- Rhythm Pharmaceuticals (Boston, MA)
- …Teams in document management and quality control processes, ensuring compliance with regulatory requirements (GCP, E6 ICH Guidelines, relevant regulations, ... TMF Specialist works with cross-functional teams, including Clinical Operations, Quality Assurance, and Regulatory Affairs, to ensure the Clinical Studies… more
- Federal Home Loan Bank of Boston (Boston, MA)
- …+ Maintain constructive working relationships with all internal and external regulatory / compliance stakeholders. + Actively engage in selected initiatives ... Senior or Lead Bank/Treasury Operations Specialist Location Boston Apply Now (https://phh.tbe.taleo.net/phh01/ats/careers/v2/applyRequisition?org=FHLBBOSTON&cws=38&rid=420) The Federal… more
- Hologic (Marlborough, MA)
- … to join our dynamic team. This role is critical in ensuring compliance with applicable regulations and quality management systems (QMS) requirements, ... Medical Device Reporting Specialist - Marlborough, MA Marlborough, MA, United States...in a timely manner. + Liaise with the International Quality group to ensure compliance with international… more
- Feeney Brothers Utility Services (Worcester, MA)
- …observe safety rules. + Provide safety training on company procedures and regulatory compliance + Actively participate in self-development and growth Position ... regulatory reviews on risk assessment. The Field Safety Specialist Lead monitors the implementation of safe work procedures...quality audits + Inspect site activities for safety compliance + Manage on-site corrective actions + Share findings… more
- Prime Therapeutics (Providence, RI)
- …+ Health insurance/PBM operations and/or contract audit experience + Experience with regulatory compliance for Medicare/Medicaid/Commercial or ACA drug benefit + ... the Client Audit Management (CAM) team, the Client Audit Specialist , Sr is accountable for managing regulatory ...seeks and obtains additional expertise as indicated from respective Compliance and operational subject matter experts to meet the… more
- Actalent (Boston, MA)
- …in the release of GMP materials by ensuring quality oversight and compliance with internal and external regulatory expectations. + Support internal and ... Job Title: QMS Specialist (25/hrs. per week) We are seeking a...areas for improvement, and implement effective solutions to ensure compliance with GMP and regulatory requirements. +… more
- Main Street Bank (Marlborough, MA)
- …+ Monitors all flood insurance, hazard and PMI insurance for loans ensuring compliance with regulatory requirements as well as payment of premiums. Manage ... Loan Servicing Specialist II Job Details Level Experienced Job Location...all aspects of escrow administration, new loan funding/boarding, ensuring compliance , assisting with audits and compliance exams,… more
- Cambridge Savings Bank (Waltham, MA)
- … Specialist will also oversee Regulation E charge-off reporting, maintain compliance with regulatory requirements, and collaborate with internal teams to ... POSITION: Digital Payments Specialist Summary: At Cambridge Savings Bank, our purpose...and refine Zelle specific risk mitigation strategies. + Ensure compliance with all regulatory requirements related to… more