Quality Management Specialist
About The Position
The Quality Management Specialist utilizes broad experience in Quality System Management to ensure that ConnectiveRx’s Quality Management System conforms to internal policies, applicable regulations, and customer expectations. Additionally, the Quality Management Specialist leverages knowledge in Quality Improvement to drive meaningful enhancements to critical business processes and systems. The Quality Management Specialist is responsible for coordinating activities related to Deviations and CAPAs, document changes, vendor qualification and vendor risk management, training, as well as coordinating or supporting customer, third-party and/or regulatory audits, and supporting activities aimed at Quality Improvement initiatives. The incumbent will play an active role in maintaining and building enterprise quality management processes and controls and works to maintain a constant state of audit-readiness.
Requirements
- Bachelor’s degree or equivalent experience in a science, technology, mathematics, engineering, quality or related field required.
- 3 years of experience in quality systems management, including experience effectively leading internal, third-party, client and/or regulatory audits and successfully leading cross-functional teams and projects at an enterprise scale.
- Firm understanding of how Quality Systems are built, managed and maintained.
- Proficiency with Microsoft Office applications.
- Proven ability in data analysis.
- Excellent written and verbal communication skills.
- Ability to manage multiple high-priority tasks and priorities simultaneously.
- Adhere to all Company Policies, Procedures, and other training consistent with ConnectiveRx’s Information Security and Compliance Programs, including but not limited to SOC1, SOC2, PCI, and HIPAA requirements.
- Maintain strict compliance with company and client policies regarding business rules and ethics, as well as applicable local, state, and federal laws.
Nice To Haves
- One or more of the following professional certifications is preferred: Lean/Six Sigma Green Belt or Black Belt certification (CSSGB or CSSBB), Certified Project Management Professional (PMP), Quality Auditor Certification (CQA), Quality Improvement (CQIA), Process Improvement (CQPA), Supplier Quality (CSQP), ISO9001:2015 Auditor or equivalent certifications.
- Familiarity with the US healthcare system and medical, clinical or pharmacological terminology is considered a plus.
Responsibilities
- Coordinate and lead work for management of Deviations and CAPAs, including root cause analysis, corrective and preventive actions, and effectiveness checks.
- Support internal, vendor and external audits as needed. Maintain a constant state of audit-readiness. Assist with any necessary follow-up actions resulting from audits to ensure satisfactory audit closure.
- Calculate, record and analyze Quality System data and report and present Key Performance Indicators to management and/or customers. Identify areas of greatest need or opportunity for improvement.
- Provide guidance and advice to other Quality personnel, internal groups and project teams on matters pertaining to the Quality System.
- Cooperate with other Quality personnel and ConnectiveRx teammates to support Continuous Quality Improvement initiatives.
- Review and process Document Change requests for new/revised controlled documents. Coordinate routine controlled document reviews with document owners.
- Maintain and routinely evaluate training assignments and training plans for the ConnectiveRx electronic Learning Management System. Routinely assess training compliance and intervene to address training compliance problems.
- Participate in and provide Quality expertise to complete Vendor Risk Assessments in partnership with Information Security and Procurement. Assist Information Security, Procurement, and the Business Relationship Owner in managing and remediating any identified risks for approved vendors.
- Assist HR and IT with employee onboarding and orientation.
Benefits
- medical, dental, vision, life, and disability insurance
- 401(k) plan, with employer contributions where applicable
- flexible paid time off (PTO) policy for exempt employees, covering sick days, personal days, and vacations
- eight standard company holidays and three floating holidays annually
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
