QA Associate II

EHS Analyst

Production Technician I

Manager - Card Authorisation & Fraud Detection Analyst 

Solar Design Engineer

Product Development Engineering (Mechanical)

Role Description: <ul><li>The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities.</li><li>Communicates to multiple departments and supervision to provide timely process and issue updates.&nbsp;</li><li>Identifies and escalates issues or problems to appropriate supervision.</li><li>Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement</li></ul> Responsibilities: <ul><li>Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.</li><li>Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.</li><li>Is competent in all relevant processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams &amp; Ointments Mfg. and Batch Transfer, Packaging, etc.) Follows internal processes related to controlled substances.</li><li>Performs GMP-related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures</li><li>Actively participates in process validation and equipment qualification activities.</li><li>May execute computer data entries in SAP, Leucine, LIMS, and department databases.</li><li>Sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes.</li><li>Performs manufacturing/packaging stage reviews of batch records.</li></ul> Requirements: <ul><li>High school diploma or equivalent with 4-7 years’ relevant experience OR</li><li>AA/AS degree with 3-6 years’ relevant experience OR</li><li>BA/BS degree with 2 -5 years’ relevant experienceRelated discipline and certification in assigned area a plus.</li><li>Experience with statistical sampling methods a plus.</li></ul> Knowledge &amp; Skills <ul><li>Attention to detail.</li><li>Strong documentation skills.</li><li>Ability to read and interpret SOPs and function within the scope of procedures.</li><li>Proficiency with basic math skills and basic experience with computers and software applications required.</li><li>Ability to learn new processes and procedures.</li><li>Able to communicate effectively with other departments, management and operational personnel.</li><li>Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).</li><li>Proof-reading skills; ability to identify errors.</li><li>Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs).</li><li>Experience with Enterprise Resource Planning (ERP) system is a bonus.</li><li>Ability to work overtime as needed, including occasional weekend shifts.</li></ul> Physical Requirements <ul><li>Lift 15 lbs.</li><li>Walk across plant/warehouse.</li><li>Wear appropriate gowning as required.</li><li>Ability to read for extended periods of time.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Key responsibilities Authoriser - Card Authorisation • Process and authorize credit &amp; debit card transactions in a timely and accurate manner. •Perform voice-authorisation and give assistance to merchants and customers at POS transactions. • Meeting Service Level Agreements (SLA) standards on pick-up call (for merchants and customers). • Manage email duties, assisting Call Centre &amp; RMs on block/unblock cards, temporary increase limit adjustment, and bypass security check for customers. • Support Cards &amp; Payments (CPP) Cards Operations to process Authorisation code for unsecured products.&nbsp; Authoriser – Merchant and Customer Support • Establish and maintain relationships with merchants, providing support and guidance on credit &amp; debit card transaction processes. • Assist merchants with inquiries and resolve any issues related to card authorizations. • Assist in transaction code cancellation request receive from merchants, customers and Contact Centre. • Respond to customer inquiries regarding credit &amp; debit card transactions and account statuses. • Educate customers on card usage, security, and fraud prevention. • Assist customer to adjust Temp Increase Limit. • 24/7 emergency card replacement support. • Act as point-of-contact with Card Scheme&nbsp;&nbsp; Authoriser – Card Surveillance Support (transaction monitoring) • Monitor and review card transactions for potential fraud and irregularities. • Monitor cards transaction in real time alerts queue and identify high risk transactions. • Monitor and analyze transactions to detect fraudulent activities using Visa/Mastercard fraud detection tools. • Observe customer transactions and identify suspicious and fraudulent activities such as account take over (scam fraud), friendly fraud, lost &amp; stolen card, and Credit Master attacks. Block/unblock cards, and attempt transaction cancellation when necessary. • Contact customer or manually trigger SMS notification to alert customer of suspicious transaction and perform verification with customer. • Follow-up on uncontactable customer by calling or sending SMS to notify to mitigate losses. • Manage customers expectation and explain to customer on fraudulent transactions and scam activities. • Support Fraud Investigation Team and Fraud Issuing team when required on fraud matters. • Perform merchant ID blocking to prevent Bin attack fraud and support CPP on parameter maintenance for 3DS system. Requirements • Diploma or equivalent qualification preferred. • Proficient in English. Ability to converse in in Mandarin (and dialects), Bahasa Malay, Tamil will be a plus. • Able to use MS Office and possess good written and communication skills. • Pleasant disposition with good interpersonal skills. • Possess strong analytical skills. • Possess high standard of customer service.&nbsp;

Responsibilities: <ul><li>Work with cross functional teams to transform VOC into internal specifications and design features, documented properly as Product Requirements Document.</li><li>Design and develop new products for renewable applications using metallic and polymeric material to meet customer requirements</li><li>Assess technical risk and compliance of project</li><li>Prototype sample development for feasibility studies</li><li>Product Data management of engineering bill of materials</li><li>Executing on cost optimization/reduction (VA/VE) opportunities for the business</li><li>Engineering communication with global team and localize global product teams in China</li><li>Preparing design verification test plans, Design C Process FMEAs, FEAs</li><li>Engineering sample preparation for design and process verification tests</li><li>Executing test plan within the lab, ensuring successful product testing and verification results</li><li>Perform failure mode analyses and improvements to optimize product</li><li>Recording results of design reviews, design decision meetings, and writing technical summaries</li><li>Assisting with product compliance and approvals for all new products and platforms</li><li>Work with FAI approvals, Process Capability Study, judging manufacturing deviations and make decisions on deviation acceptance</li></ul> Requirements: <ul><li>Must have a minimum of an Bachelors degree in a discipline of Engineering</li><li>More than 5 years design experience on connector, plug or terminal. Solar or battery energy storage relevant or power / utility design experience is plus,not must</li><li>Ability to develop connectors to meet critical global standards, such as ANSI, UL, IEEE, and IEC</li><li>Component material selection to optimize strength, electrical insulation, stability, and longevity, while meeting the product and standard requirements</li><li>Basic knowledge of product development processes in a stage-gate approach</li><li>A basic understanding of manufacturing processes, such as molding, stamping, plating, and assembly processes</li><li>Possesses high degree of initiative, technical competence, engineering process knowledge and strong communication skills</li><li>Fluent communication with own team, customers, internal business leaders and technology leaders in English (CET-4 or above)</li><li>LDFSS or DMAIC 6-sigma black or green belt an advantage</li><li>Familiarity of engineering software: Creo or Pro/E</li><li>Mastery of office software, such as Word, Excel, PPT, etc.</li></ul>

Responsibilities: <ul><li>Designing and developing new products to meet customer requirements within scope, schedule, and budget constraints by following company LeanPD process.</li><li>Innovating original ideas and design proposal for new products, studying the feasibility of customer specifications.</li><li>Leading new product technical data output, such as: 3D, 2D drawing and Design objective.&nbsp;</li><li>Initiating product design document, such as: PRD, DV/PV plan, Product review, Initial BOM, DFMEA and Significant Characteristic.&nbsp;</li><li>Leading product design review with function team and technical review with customer, and communicating with supplier feasibility study of components material.&nbsp;</li><li>Performing engineering calculations to analyze and describe product to ensure robust design with economic cost.</li><li>Working with FAI approvals, technical risk analysis, supporting 8D report and 5 WHY analysis, judging manufacturing deviations and making decisions on deviation acceptance.</li><li>Improving and enlarging existing products, quality improve and manufacture engineering support. Helping resolve technical problems or providing solutions of avoiding problems to ensure accurate implementation of production.</li><li>Understanding product testing procedures and equipment, reviewing evaluation or test report and confirming accuracy of report contents to ensure product meets quality specification.</li><li>Reviewing patent searches to evaluate patentability of proposed designs to ensure that others patents are not infringed upon.&nbsp;&nbsp;</li><li>Providing innovative solutions to reduce product cost, improving product quality, and improving process efficiency, documents and communicates potential IP to ensure TEs IP is protected.</li><li>Providing technical support to customers and Sales Engineers to ensure proper application of products in the field.</li></ul> Requirements: Education:&nbsp; <ul><li>B.S. of Engineering or Master or PHD, Mechanical Engineering preferred.</li></ul> Qualification &amp; Certification: <ul><li>Ability to perform complicated product development.</li><li>Be familiar with the customers requirements and transforms them into design objectives through communication with the customer.&nbsp;&nbsp;</li><li>Be familiar with related automotive standards such as USCAR, SAE,LV15, etc.</li><li>English good.</li></ul> Experience: <ul><li>B.S. of Engineering with 5 or more years of experience or Masters of Science with 2 or years of experience or PHD</li><li>More than 2 years HV Connector Design related experience.</li></ul> Technical Skill &amp; Competencies: <ul><li>Be familiar with product development process and related product manufacturing process.</li><li>Understanding of special characteristic significance for customer and TE</li><li>Understanding of basic automotive industry core tools, such as APQP, FMEA and PPAP.</li><li>A complete understanding and wide application of technical theories, principles, engineering tools and techniques, such as: GD&amp;T, DFM, DFA, DFSS, etc.</li><li>Ability to skillful use Cero software and drawing design, tolerance calculation.</li><li>Familiar with stamping, plating, molding, assembly and machine Application process.</li><li>Understanding of relevant technical standards and law regulations.</li><li>Ability to build strong internal/external working relationship.</li><li>Effective Interacts and communication within the team.</li></ul>

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6 deviation investigation Jobs found

QA Associate II

EHS Analyst

Production Technician I

Manager - Card Authorisation & Fraud Detection Analyst

Solar Design Engineer

Product Development Engineering (Mechanical)

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6 deviation investigation Jobs found

QA Associate II

EHS Analyst

Production Technician I

Manager - Card Authorisation & Fraud Detection Analyst

Solar Design Engineer

Product Development Engineering (Mechanical)

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.