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Quality and Compliance Specialist (GCP Auditing)

Company: MMS
Location: Boston
Posted on: February 25, 2021

Job Description:

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.Responsibilities:* Provide Quality Management System support to clients to include auditing, document creation/ revision, and other support as needed.* Provide Learning Management System Support to clients to include system development and maintenance.* Plan and conduct GxP audits in the Medical Device, Biological Drug/Agent, and/or Pharmaceutical realm. Audits may include investigator site, sponsor, Mock Inspection, process, quality assurance/quality management system, software/computer system qualification and validation, vendor (including vendor qualification), and/or bioanalytical/bioequivalent/pharmacokinetic. * Report Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.* Assist with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required by the client.* Write confirmation letters, and audit plans, agendas, reports and other required audit documentation. * Provide drafts of required documents, and finalize following internal QA and sponsor reviews according to project timeline.* Provide GCP and inspectional preparedness training to clinical sites, vendors, and sponsors as required by client.* Provide good documentation training to auditees as required by client.* Perform gap analysis of SOPs and procedures as required by client.* Review, develop and revise client procedures, guidance documents, form templates, and quality documentation as required by client.* Perform all audit-related activities in accordance with MMS procedures and using MMS document templates, or client procedures and templates as required by the client.Required Qualifications:* Bachelor's degree or higher in biomedical, nursing or related life science discipline required.* Minimum 5 years relevant auditing experience preferred.* Minimum 2 years SOP development experience preferred.* Minimum 2 years GxP training experience preferred.* Comprehensive understanding of ICH Guidelines [i.e., ICH E6 (R1) and ICH E6 (R2)], appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.* Training to and understanding GDPR requirements relative to clinical research preferred.* Excellent demonstrated verbal and written communication skills* Ability to travel up to 50%, both domestically and internationallyPowered by JazzHRlPU11nKnuv

Keywords: MMS, Boston , Quality and Compliance Specialist (GCP Auditing), Other , Boston, Massachusetts

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