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 quality
Successfully develop and lead a team of DC Quality Technicians
Plan and monitor the day-to-day operations
DC is a right first time product, The candidate must understand fully the associated quality acceptance criteria and highlight anything that may not meet specification
Conduct operations in a safe manner and be fully committed to maintain a clean and safe working environment
Evaluate, monitor, and increase the productivity within the team
Review and evaluate site Quality team performance
Maintain 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 directed
Coordinate calibration activities at all ABEC DC facilities
Report on the status and metrics of the quality program and drive the improvement implementation.
MRB Process signer, and trend analysis
Organize 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 assigned
Ability to travel when required
Desired attributes:
O Experience with reporting of KPI metrics of the quality program for specific site such as DPM
O Two (2) years supervisory experience
O CQE, CQM and Six Sigma
O Experience with data analytics
O Five (5) years previous experience preferably working in a classified clean environment
O Extensive knowledge of industry's legal rules and guidelines
Qualifications:
Self-motivated
Must be capable of maintaining a clean and safe working environment
Bachelor's Degree in an Engineering discipline or related Life Sciences field
Experience 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 skills
Ability to read tape measure and perform simple mathematical equations
Aptitude with blue print reading
Ability to stand for long periods of time
Ability to stand, sit, walk, bend, stoop, reach, lift, push, pull and carry items
Ability to wear all personal protective equipment & cleanroom gowning equipment