Senior Quality Assurance Compliance Specialist Job Rochester area,Michigan USA,Quality Assurance

What You Will Achieve

Evaluate corrective and preventive action (CAPA) responses to internal and external audit observations for adequacy, effectiveness, and timely completion.
Ensure Quality Assurance policies, procedures, and quality system records remain current and compliant with applicable regulatory requirements, corporate quality requirements, and site procedures.
Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments, ensuring timely development, implementation, and closure of resulting action plans.
Manage, investigate, and document customer quality complaints for commercial drug products within the global complaints management system, ensuring thorough root cause analysis, timely investigations, and appropriate quality decisions.
Collaborate with internal stakeholders, manufacturing sites, suppliers, contract manufacturers, and quality partners to ensure complaint investigations and quality records are completed in accordance with established procedures and regulatory expectations.
Support the Supplier Quality Management Program through supplier qualification, monitoring, performance trending, issue escalation, supplier corrective action management, and quality risk assessments, as applicable.
Assist with technical investigations involving product, process, component, and equipment-related quality issues, providing quality oversight and support for testing activities and protocol execution.
Collect, analyze, interpret, and trend quality and operational data using appropriate statistical and risk-based methodologies to identify opportunities for continuous improvement and risk mitigation.
Review quality system documentation and performance metrics, conduct trend analysis, and identify emerging issues requiring corrective or preventive action.
Promote and ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, data integrity principles, and company procedures.
Support quality investigations, deviation management, change management, effectiveness verification activities, and continuous improvement initiatives across site quality systems.
Prepare reports, presentations, and quality metrics to communicate findings, risks, recommendations, and quality system performance to management and stakeholders.

Here Is What You Need (Minimum Requirements)

High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes
Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
Excellent technical writing, communication, and presentation skills
Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
Experience in preparing and participating in audits and inspections

If You Have (Preferred Requirements)

Background in handling complaints and utilizing electronic lab systems
Strong analytical and problem-solving skills
Ability to work independently and as part of a team
Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
Ability to adapt to changing priorities and manage multiple tasks simultaneously
Experience in mentoring and training colleagues
Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and…