MEDVACON LIFE SCIENCES, LLC · 10 hours ago
QC Stability Consultant – Subject Matter Expert (SME)
Houston, TX
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expMEDVACON LIFE SCIENCES, LLC is seeking a QC Stability Consultant SME to support the design, implementation, and continuous improvement of the pharmaceutical stability program. The role involves providing strategic and technical expertise to ensure compliance with global regulatory requirements and partnering cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing.
ConsultingHuman ResourcesLife ScienceQuality Assurance
Responsibilities
Lead and advise on all aspects of stability study design, execution, and data interpretation in accordance with ICH guidelines and company SOPs
Review and approve stability protocols, reports, and trend analyses for new and existing products
Assess and optimize current stability program systems, workflows, and documentation for regulatory compliance and efficiency
Provide technical guidance during audits, inspections, and regulatory submissions
Develop and deliver training for QC and QA personnel on stability testing procedures and data management
Evaluate and support implementation of digital tools or LIMS enhancements for stability management
Support investigations and CAPAs related to stability data deviations or OOS results
Collaborate with product development teams to ensure appropriate stability testing during lifecycle management and change control
Qualification
Required
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or related field
Minimum of 10 years of experience in pharmaceutical Quality Control, with at least 5 years focused on stability programs
Deep knowledge of ICH Q1A–Q1F, GMP regulations, and related global stability guidelines
Proven experience preparing and defending stability data in regulatory audits and submissions
Strong analytical, problem-solving, and project management skills
Excellent written and verbal communication skills
Preferred
Ph.D. preferred
Experience with LIMS, Empower, or other electronic data management systems preferred
Demonstrated leadership in implementing or remediating global stability programs
Experience with biologics or sterile drug products
Ability to manage multiple priorities in a fast-paced, regulated environment
Strong interpersonal skills and the ability to influence cross-functional teams
Company
MEDVACON LIFE SCIENCES, LLC
MEDVACON is a globally recognized company offering tailored FDA Quality Compliance and Technical Consulting Services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Raymond Roggero
Managing Partner
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