Senior Quality Specialist

LabConnect; Oakland Village (TN); Hybrid; USD 90,000 - 130,000; Full time

Job summary

LabConnect seeks a senior Quality Assurance professional to lead QMS activities, including document control, change control, non-conformance reporting, and supplier qualification/requalification.

You will serve as the team lead CSV specialist, supervise data reporting, train users, and drive process improvements to support regulatory inspections and quality consulting across internal and external stakeholders.

Qualifications

• 4-year degree preferred with 5-7 years of QA experience; or 2-year degree with 8-10 years related experience.
• Veeva Belt certification preferred.

Responsibilities

• Leads and project manages QMS activities including document control, change control, non-conformance reporting and supplier qualification/requalification.
• Serves as team lead CSV specialist.
• Responsible for data reduction, metrics and managerial reports delivery.
• Trains QMS users on workflow and associated tasks for modules within the QMS.
• Lead se QMS configuration and improvement specialist.
• Assesses, creates, and presents QMS Lean and Process Efficiency opportunities and projects.
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses.
• Provide industry leading QMS compliance guidance and quality assurance consultation to internal and external stakeholders.

Skills

Strong organizational skills

Interpersonal skills

QMS experience

Education

4-year degree preferred; 5-7 years QA experience

2-year degree with 8-10 years related experience

Veeva Belt certification preferred

Tools

QMS platforms (Veeva)

Job description

Essential Duties and Responsibilities

• Leads andproject managesQMSactivitiesincluding document control, change control, non-conformancereportingand supplier qualification/requalification
• Serves as team lead CSV specialist
• Responsible for data reduction,metricsand managerial reports delivery
• Supervise andassistin management ofQMSNon-Conformance reporting and their relatedinvestigation, root cause analysis, proposed corrective and/orpreventive measures,and due diligence thereto
• TrainsQMS users on workflow and associated tasks for modules within the QMS
• LeadseQMSconfiguration and improvement specialist
• Assesses, creates, and presentsQMSLean and Process Efficiency opportunities and projects
• Assistsmanagement in assuring organizational readiness for regulatory inspections by scheduling, coordinating,conductingand documentingQMS modulegap analyses
• Provide industry leadingQMScompliance guidance and quality assurance consultation to internal and external stakeholders
• Clear and concise communication ofQMSreporting for regulatory and quality consulting advisements
• Schedules and conducts monthly quality review meetings asrequired
• Prepare training materials and conduct training for QMStopics
• Collaborates with Human Resourcesregardingtraining program requirements affected by the QMS
• Serves as Quality subject matter expert for configurable systems validation projects
• Conducts research, and compiles andtypesstatistical reports
• Performs other tasks as defined by the QualityAssuranceLeadership

Education and Experience

• 4 -year degree preferred with5-7years of Quality Assurance Experience; ora 2-year degree with8-10yearsrelated experience and/or training; or equivalent combination of education and experience.
• Veeva Belt certification preferred.

Skills and Ability

• Mustpossessstrong organizational and interpersonal skills.
• Experience with QMS platforms such as Veeva is highly preferred.
• Proventrack recordof leading QMS implementations or enhancements is a strong asset.

Supervisory Responsibilities:

None

Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.

Travel Requirements:

Minimal