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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 processes to support the overall Quality Assurance and Quality Control plan. This role drives Quality improvement throughout the DC business process and participates 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
Understand fully the associated quality acceptance criteria and highlight any that do not meet specification
Conduct operations in a safe manner and 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 SOPs
Support and maintain ABEC quality procedures, practices and guidelines, including 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‑and 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 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
Experience with reporting of KPI metrics of the quality program for specific sites such as DPM
Two (2) years supervisory experience
CQE, CQM and Six Sigma
Experience with data analytics
Five (5) years previous experience preferably working in a classified clean environment
Extensive knowledge of the 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 blueprint 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
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Quality Assurance
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