Quality and Compliance Specialist (GCP Auditing)
Company: MMS
Location: Canton
Posted on: February 18, 2021
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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
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Keywords: MMS, Canton , Quality and Compliance Specialist (GCP Auditing), Other , Canton, Michigan
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