Quality Compliance Analyst

This roleisresponsible forexecuting and supporting regional operations in the areas of Document Management Quality Compliance and SOX Reporting and for providing superior advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations.

Key Responsibilities:

Day-to-Day Activities: 70%

• Support and continually work within the parametersestablishedby a risk-based Quality Management System framework.

• Serve as theCustomer Service (CS)Subject Matter Expert (SME)regardingSOX financial reporting Quality and Compliance.

• Benchmark internally and externallyregionallyand globally to gather share and implement standard methodologies accordingly.

• Assist CS Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes using technology and other platforms to standardize leverage and/oreliminatemanual interactions wherever possible.

• Lead and manage projects related to broader Supply Chain initiatives as.

• Your Key Performance Indicators for this role include on-time completion/compliancewith SOX reporting.

• Support change management strategies by applying change management principles and tools

• Support the development and maintenance of internal resources to provideaccurateSOX financial Quality and Compliance information.

Day-to-Day Activities: 10%

• Provide CS Quality & Complianceexpertiseon applicable projects.

• Lead and/or support key departmental/cross-functional/cross-sector projects as assigned by developing andutilizingin-depth knowledge of business processes and systems as well as project management skills.

• Use continuous improvement tools andmethodology including Process Excellence LEAN and project management toidentify evaluate challenge develop solutions andoptimizebusiness processes that drive measurable improvement.

• Regularly communicate in all directions to keep associates peers and Management informed of project status process changes and opportunities.

• Drives / supports regional and global CS projects for the US region using FPXmethodologytoolsand best practices.Conducts lessons learned post-implementation andidentifiesopportunities to continuously improve.

Dat-to-Day Activities: 10%

• Support documentation management Quality and Job Function Curriculum (JFC).

• Support with managing departmental/Regional Change Control documentation and deliverables to ensurethe on-time completion.

• Support with the on-time completion of Annual Training Record Review (ATRR) and lead on-time completion of controlled document periodic review.

• Support with Key Performance Indicators for On-Time Periodic Review.

• Support with development implementation and evaluation ofmetrics with meaningful insightsforcustomer service in the areas of Document Management.

Day-to-Day Activities: 10%

• Complete required compliance/assigned training by required due date.

• Allduties asassigned by manager and/or supervisor.

Qualifications

Education

• Required:Bachelors degree in Quality Engineering Supply Chain Life Sciences Business ora relatedfield.

• Preferred: Coursework or concentration in Quality Management Regulatory Affairs or Operations.

Experience and Skills

Required:

• 2 to 4yearswork experience in relevant Quality Compliance or Supply Chain position within a regulated fast-paced business environment

• Work experience in Quality Compliance Document Management/Control Technical Writing or Supply Chain

• Ability to analyze basic data andidentifytrends to support continuous improvement.

• Proficiencywith standard office and data tools (e.g.Microsoft Office).

• Demonstrated time management skills with consistenttrack recordto handle multiple competing priorities/deadlines ability to act with a sense of urgency and deliver expected/exceeding results

Preferred:

• Experience in a medical device pharmaceutical or other regulated industry.

• Exposure to audits CAPA change management or supplier quality activities.

• Familiarity with Lean Six Sigma or continuous improvement methodologies.

• Experience supporting global ormultisiteoperations.

• Ability to work effectively incrossfunctionalteams.

• Effective written and verbal communication skills.

• Strong attention to detail and ability to manage documentation accurately.

Other:

• Language: English (required).

• Travel: Up to 10% domestic and/or international as needed.

• Certifications:Qualityrelatedcertifications (e.g. ASQ) preferred not.

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