Company Background:ABEC is a leading supplier to the biopharmaceutical manufacturing industry. ABEC's unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximise productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilisation systems.Position Summary:The Quality Team Lead leads the site DC Quality team with implementation of company-wide operations procedures and process to support the overall Quality Assurance and Quality Control plan. This role drives Quality improvement throughout the DC business process. This role will participate as a cross-functional team member within the assigned goal-oriented team.Responsibilities:Accountable for the KPIs in DC qualitySuccessfully develop and lead a team of DC Quality TechniciansPlan and monitor the day-to-day operationsDC is a right first time product, The candidate must understand fully the associated quality acceptance criteria and highlight anything that may not meet specificationConduct operations in a safe manner and be fully committed to maintain a clean and safe working environmentEvaluate, monitor, and increase the productivity within the teamReview and evaluate site Quality team performanceMaintain and ensure compliance to ABEC Standard Operating Procedures (SOPs).Support and maintain ABEC quality procedures, practices and guidelines, including best industry practices such as Good Documentation Practices (GDP).Participate in process, internal and mock customer audits, as directed.Support vendor qualification or re-qualification audits, as directed.Coordinate and support Customer audits of the ABEC site, as directed.Drive and Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions)Coordinate assigned Continuous Improvement initiatives, driving both cost and process improvements.Coordinate Quality System Change Management assignments as directedCoordinate calibration activities at all ABEC DC facilitiesReport on the status and metrics of the quality program and drive the improvement implementation.MRB Process signer, and trend analysisOrganize and conduct in-process inspections and prepare reporting documents as required during manufacturing and packaging of DCs.Inspection of incoming materials & components, ABEC manufactured items, and assembled systems to ensure conformance to established quality standards and all related quality documentation requirements.Ensure accurate and complete development of all required quality-related documentation.Execute other tasks as assignedAbility to travel when requiredDesired attributes:O Experience with reporting of KPI metrics of the quality program for specific site such as DPMO Two (2) years supervisory experienceO CQE, CQM and Six SigmaO Experience with data analyticsO Five (5) years previous experience preferably working in a classified clean environmentO Extensive knowledge of industry's legal rules and guidelinesQualifications:Self-motivatedMust be capable of maintaining a clean and safe working environmentBachelor's Degree in an Engineering discipline or related Life Sciences fieldExperience with cGMP, ISO 9000 or equivalent.Two (2) years previous experience preferably working in a classified clean environment.Experience in producing documentation that is subject to quality and customer audit.Excellent communication and problem solving skillsAbility to read tape measure and perform simple mathematical equationsAptitude with blue print readingAbility to stand for long periods of timeAbility to stand, sit, walk, bend, stoop, reach, lift, push, pull and carry itemsAbility to wear all personal protective equipment & cleanroom gowning equipment