Structural Engineer

Quality Associate I

Continuous Improvement Analyst III

Senior Quality & Reliability Engineer

Senior Project Management Engineer

QE Specialist

Procurement Manager

Executive Assistant to Group CEO (Operations – Steel & Power)

Quality Engineer

Associate, Quality Assurance (QMS)

Role Description: <ul><li>This position will require an experienced, results-oriented professional to be responsible for Structural engineering.</li><li>The position will work in a multi-discipline team executing a variety of chemical manufacturing support projects and tasks to support our manufacturing sites.</li></ul> Responsibilities: <ul><li>Work with remote team members and global counterparts to develop deliverables required for structural fabrication and installation of projects and hence excellent communication skills a pre-requisite.</li><li>Provide structural analysis and engineering calculations of a variety of material types including but not limited to steel and concrete.</li><li>Provide structural analysis of steel and concrete elements.</li><li>Well versed with connection design calculations.</li><li>Participate in team model reviews.</li><li>Review Design Drawings</li></ul> Requirements: Basic Qualifications: <ul><li>Master’s degree in Structural Engineering from a reputed premiere institute.</li><li>Minimum 5 years of work experience in an Engineering and/or Engineering Services organization.</li><li>Must have engineering experience performing structural calculations and analysis of structures.</li><li>Computer Environment: Microsoft: Word, Excel, Power Point</li><li>Proficiency in STAAD Pro software</li><li>Should have exposure to environments of 2D and 3D CAD tools including Laser Scans, Bentley MicroStation, AVEVA and AutoCAD platforms or equivalent.</li><li>Experience with applicable industry codes including ACI, AISC, IBC and ability to utilize custom internal specifications as they apply to design and installation of structural assemblies and supports. Be able to perform tasks using U.S. or metric standards</li><li>Excellent written, listening, and verbal communication skills.</li></ul> Preferred Qualifications: <ul><li>Exposure to environments of 2D and 3D CAD tools including Laser Scans, Bentley MicroStation, AVEVA and AutoCAD platforms or equivalent.</li><li>Experience with applicable industry codes including ACI, AISC, IBC and ability to utilize custom internal specifications as they apply to design and installation of structural assemblies and supports. Be able to perform tasks using U.S. or metric standards.</li></ul>

Responsibilities: <ul><li>Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.</li><li>Ensure adherence to cGMP, SOPs, and regulatory standards.</li><li>Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities</li><li>Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.</li><li>Take active role in preparing the site for regulatory inspection.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits.</li><li>Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications / Experience <ul><li>Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).</li><li>5+ years of experience in pharmaceutical manufacturing, or QA.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills / Competencies <ul><li>Strong knowledge of 21 CFR part 10, and 211.</li><li>Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, and engineering.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Responsibilities: <ul><li>Facilitate, lead, or coach Kaizen and Kaizen events across the organization.</li><li>Work collaboratively with tool or element owners to implement Continuous Improvement tools.</li><li>Lead and audit Continuous Improvement tools.</li><li>Train teams in Continuous Improvement methodologies, tools, and transformation methods (e.g., 5S, TPM, Value Stream Mapping, VSM-D, CCF, 3P, Lean Manufacturing).</li><li>Facilitate and train teams for transformation Kaizen events in highly impactful areas or production cells.</li><li>Obtain internal certifications such as Novice, Apprentice, and Practitioner level in Continuous Improvement.</li><li>Provide coaching to Novice and Apprentice practitioners.</li><li>Train and coach teams on plant Key Performance Indicators (KPIs).</li><li>Report periodic progress on assigned tools, metrics, and initiatives.</li><li>Conduct capacity analysis and mentor production supervisors on managing line capacity.</li><li>Develop scenarios for capacity planning, including footprint analysis.</li><li>Apply advanced knowledge in line balancing and its implications for realistic planning (cross-training, validations, capacity planning, hiring requirements, etc.).</li></ul> Requirements: Knowledge &amp; Experience <ul><li>Bachelor’s Degree in Industrial Engineering or related field.</li><li>3–5 years of experience in continuous improvement, cost savings, or productivity improvement roles.</li><li>Lean certification required.</li><li>Green Belt or Black Belt certification is desirable.</li><li>Experience in process improvement, Six Sigma, and product/process qualification and validation.</li><li>Bilingual (English/Spanish).</li></ul> Skills <ul><li>Proficiency in Microsoft Office 365.</li><li>Strong skills in Excel (Pivot Tables, Charts, Macros), PowerPoint, MS Project, AutoCAD (or similar), Minitab, and simulation software.</li><li>Knowledge of problem-solving techniques.</li><li>Basic competency in creating dashboards using Power BI.</li><li>Basic knowledge of Power Automate or similar tools.</li><li>Ability to work under pressure with strong communication and teamwork skills.</li><li>Experience influencing all organizational levels to support an Operational Excellence culture.</li></ul>

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Role Description: <ul><li>Reporting to the Head of Procurement, the Manager, Procurement is responsible for overseeing and managing all procurement activities within the indirect categories in the organisation. </li><li>This role encompasses the development and execution of procurement strategies, supplier management, supply chain optimization, compliance, process excellence, and end-to-end procurement life cycle management.</li></ul> Responsibilities: <ul><li>Develop and implement a comprehensive procurement strategy on indirect spend aligned with the organizations goals and objectives.</li><li>Provide strategic guidance and support to the procurement team and collaborate with senior leadership to align procurement goals with broader business objectives.</li><li>Engage with stakeholders to understand business needs, ensure that procurement policy and guidelines support the needs of the organization, and that best practice is delivered</li><li class="ql-align-justify">Develop sustainability strategy within the procurement function in collaboration with key critical vendors</li><li>Conduct industry research to identify potential suppliers and support the vendor qualification process</li><li class="ql-align-justify">Identify and eliminate waste and/or variability in the supply chain.</li><li class="ql-align-justify">Conduct due diligence on selected third-party providers to ensure quality is achieved at a reasonable cost and that transactions are legally and financially viable.</li><li class="ql-align-justify">Ensure processes and procedures are fully documented and followed. Support in audit gaps closure</li></ul> Requirements: <ul><li class="ql-align-justify">University Degree in Supply Chain and Logistics or related field</li><li class="ql-align-justify">5 years demonstrated experience in end-to-end supply chain management&nbsp;</li><li class="ql-align-justify">Professional qualification in Supply Chain and Logistics (CIPS level 5 or above)</li><li class="ql-align-justify">Knowledge of SAP ERP is an added advantage</li></ul>

Responsibilities: <ul><li>Assist the CEO in reviewing plant performance, production data, and technical reports from steel and power units.</li><li>Coordinate with project, maintenance, and operation teams for updates on production, energy consumption, and process optimization.</li><li>Serve as the liaison between the CEO’s office and functional heads, ensuring timely follow-up and closure of key action items.</li><li>Organize and document strategic meetings, board reviews, and inter-departmental coordination discussions.</li><li>Draft high-quality communications, reports, and briefing materials for the CEO.</li><li>Analyse operational KPIs and provide insights or recommendations for productivity and efficiency improvements.</li><li>Track progress of ongoing expansion, modernization, or efficiency projects.</li><li>Manage CEO’s schedule, travel plans, and meeting coordination where required.</li><li>Ensure confidentiality and proper handling of sensitive business information.</li><li>Support in preparation for stakeholder meetings (investors, government, JV partners, etc.).</li></ul> Requirements: <ul><li>B.E./B.Tech in Mechanical / Metallurgy / Electrical / Industrial Engineering, MBA or PGDM in Operations / Strategy (preferred from top ranked institutes)</li><li>Minimum 5–10 years of experience in plant operations, project management, or technical coordination roles in the steel/power sector.</li><li>Strong analytical, communication, and presentation skills.</li><li>High proficiency in MS Office (Excel, PowerPoint, Project) and ERP systems.</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities. </li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>&nbsp;Strong knowledge of validation principles and qualification documentation </li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Role Description: <ul><li>The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.</li><li>This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.</li></ul> Responsibilities: <ul><li>Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.</li><li>Support the preparation and tracking of quality metrics and trending reports.</li><li>Help coordinate internal audits and document audit responses.</li><li>Participate in documenting product quality complaints and adverse event records.</li><li>Aid in digitizing logbooks and checklists using electronic systems.</li><li>Collaborate with cross-functional teams to ensure timely and accurate documentation updates.</li><li>Provide administrative support for change control processes and quality-related meetings.</li><li>Assist in preparing documentation for regulatory inspections and external audits.</li><li>Maintain document control systems and ensure timely review and archival of QA records.</li><li>Support training documentation and tracking for QA-related procedures.</li><li>Help with data entry and analysis for quality reports using basic statistical tools.</li><li>Monitor document lifecycle and ensure version control compliance.</li><li>Participate in continuous improvement initiatives related to documentation and QMS processes.</li></ul> Requirements: Education &amp; Experience <ul><li>Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.</li><li>Preferred Education: Master’s degree is a plus.</li><li>Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).</li><li>Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.</li></ul> Physical Requirements <ul><li>On-site role at Chestnut Ridge, NY.</li><li>Standard work hours: 8 AM to 5 PM.</li><li>No travel required.</li><li>No lifting or driving responsibilities.</li></ul>

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53 audit preparation Jobs found

Structural Engineer

Quality Associate I

Continuous Improvement Analyst III

Senior Quality & Reliability Engineer

Senior Project Management Engineer

QE Specialist

Procurement Manager

Executive Assistant to Group CEO (Operations – Steel & Power)

Quality Engineer

Associate, Quality Assurance (QMS)

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53 audit preparation Jobs found

Structural Engineer

Quality Associate I

Continuous Improvement Analyst III

Senior Quality & Reliability Engineer

Senior Project Management Engineer

QE Specialist

Procurement Manager

Executive Assistant to Group CEO (Operations – Steel & Power)

Quality Engineer

Associate, Quality Assurance (QMS)

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

EMPLOYER

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