Senior - Data Engineer

Senior Quality & Reliability Engineer

Environmental Health and Safety (EHS) Manager

Senior Electrical Engineer

Quality Engineer

Associate, Quality Assurance (QMS)

QC Chemist

Senior Microbiology Technician

Sr Officer (Team Member) – Reconciliation

Staff Software Engineer (Auth0)

Responsibilities: <ul><li>Uses a set of tasks and techniques to work as a liaison among and elicit the needs of stakeholders to define and validate solutions that meet business needs, goals, or objectives.</li><li>Analyzes and synthesize information elicited from stakeholders, defines, and manages the plan to deliver requirements and documents, and manages requirements throughout the project life cycle.</li><li>Develop ETL (Extract, transform, load) process to help extract and manipulate data from multiple sources.</li><li>Reformulating or automating the existing data workflows to maximize their functioning and greater scalability.</li><li>Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, and produce actionable business insights out of it.</li><li>Need to conduct complex data analysis and improve data quality and efficiency.</li><li>Develop models to create reporting infrastructure/dashboards for business process management and data mining.</li><li>Design Summary, Detail, and Dashboard reports and management summaries which present data findings in a professional, concise, and readable format appropriate for content and audience.</li><li>Solve ad-hoc requirements of Management related to data for critical decision making</li><li>Troubleshoot data inaccuracies, identify root causes, and take corrective action</li><li>Effectively communicate and translate quantity findings (Storytelling with data) inclusive of key insights and actionable recommendations to optimize performance</li><li>Optimize reports to ensure a responsive solution when visualizing vast amounts of data.</li></ul> Requirements: <ul><li>5+ years of data engineering experience in ETL design, development, optimization &amp; testing using, Alteryx, Data Bricks, Cloud AWS Services, Python, SQL scripts,</li><li>5+ years of hands-on experience in business intelligence and in configuring, designing, and building visualizations and dashboards using Tableau and other BI tools (Tableau Prep, Tableau Dashboard, Tableau Server, Business Objects, Power BI, etc.)</li><li>Excellent problem-solving, communication, and organizational skills.&nbsp;</li><li>Experience in performance tuning and optimization of ETL processes to enhance efficiency and minimize data processing time</li><li>Detail-oriented with excellent time management and organizational skills to meet a critical deadline</li><li>Self-motivated, ability to prioritize work and multi-task across many assignments in a fast-paced work environment</li><li>Collaborated with cross-functional teams to gather requirements, design data models, and implement scalable data architectures to support business analytics and reporting needs</li><li>Proven ability to work independently and with a team.</li><li>Ability to interpret technical or dashboard structure</li><li>Experience in business domains – supply chain, pricing, sales &amp; marketing, sales, finances</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>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Responsibilities: <ul><li>Meeting with the product engineers to determine product testing parameters.</li><li>Conducting quality assurance and designing performance tests using the new testing procedures.</li><li>Troubleshooting any errors and streamlining the testing procedures. Ensuring all tests and procedures meet company and industry standards.</li><li>Preparing test reports for management.</li></ul> Requirements: <ul><li>BS Degree in Engineering or Science, 5+ years’ experience related to primary job function, Electrical Engineering preferred.</li><li>Experience with software such as Altium, Ultiboard, Multisim, AutoCAD, Space Claim, Creo, and LabVIEW desirable.</li><li>Experience with solid state power switching highly desirable.</li><li>Familiarity with 270Vdc and 1000Vdc applications desirable.</li><li>Effective communication and presentation skills required.</li><li>Ability to maintain focus and complete tasks independently and on time.</li><li>This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Candidates must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.</li></ul>

Responsibilities: Provide review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems. <ul><li>Review and approval of technology/method transfer protocols and reports.</li><li>Review and evaluation of change controls</li><li>Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.</li><li>Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.</li><li>Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.</li><li>Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.</li><li>Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.</li><li>Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.</li><li>Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).</li><li>5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.</li><li>Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.</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 validation principles and qualification documentation expectations.</li><li>Effective team leader with experience supervising QA staff and coordinating cross-functional support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders.</li><li>Sound judgment and decision-making under pressure in a dynamic manufacturing environment.</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>

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</li></ul>

Responsibilities: <ul><li>Perform daily, weekly, and monthly reconciliations of financial accounts, including bank statements, ledger accounts, and other financial records for for&nbsp;</li><li>all the Operations Centers, subsidiaries and overseas branches that CoE is supporting&nbsp;</li><li>Ensure all transactions are accurately recorded and discrepancies are promptly identified.&nbsp;</li><li>Investigate and resolve discrepancies found during the reconciliation process&nbsp;</li><li>Communicate with relevant departments to understand the root cause of discrepancies and implement corrective actions&nbsp;</li><li>Maintain detailed and accurate records of reconciliation activities&nbsp;</li><li>Prepare reports on reconciliation status, discrepancies identified, and resolutions made.&nbsp;</li><li>Assist in the development and implementation of standardized reconciliation procedures and policies&nbsp;</li><li>Suggest improvements to existing reconciliation processes to enhance efficiency and accuracy&nbsp;</li><li>Ensure compliance with internal controls, company policies, and regulatory requirements&nbsp;</li><li>Adhere and support the bank Risk &amp; Control framework through various programs which include appropriate Key Risk Controls Self-Assessment&nbsp;</li><li>(KRCSA), Key Risk Indictors (KRI), Management Risk Awareness (MRA), Incident Reporting (IRF) and Business Continuity Management (BCM)&nbsp;</li><li>Adhere to best practices in reconciliation and financial reporting&nbsp;</li><li>Liaise with internal and external stakeholders, including finance teams&nbsp;</li><li>Provide support during audits and regulatory reviews by supplying necessary documentation and explanations.&nbsp;</li></ul> Requirements: <ul><li>Diploma/ Bachelor’s degree holder&nbsp;</li><li>Previous experience in Banking &amp; Financial services industry is preferred&nbsp;</li><li>Some knowledge and understanding on operational risk management and financial industry regulations will be a plus&nbsp;</li><li>A team player, strong interpersonal and communication skills.&nbsp;</li><li>Ability to work effectively, under pressure, in a rapid changing environment, as well as autonomously and as an effective member of a dynamic team.&nbsp;</li><li>Possesses good analytical and problem-solving skills&nbsp;</li><li>Self-driven, meticulous and able to operate expeditiously to deliver results and meet tight timelines&nbsp;</li></ul>

Responsibilities: <ul><li>Build secure, performant, cross-platform applications for both customers and internal company teams.</li><li>Collaborate across teams to solve technical and non-technical challenges.</li><li>Work closely with Product and Design to determine and optimize user experience and information architecture.</li><li>Build new features and maintain existing features by contributing across the full technical stack.</li><li>Debug and resolve production issues and implement fixes for them.</li><li>Be a part of the teams on-call rotations.</li><li>Evaluate new technologies and techniques to improve overall practices.</li></ul> Requirements: <ul><li>Must have 7+ years of expertise in full-stack development.</li><li>Have a passion for learning.</li><li>Have excellent communication and collaboration skills.</li><li>Are customer-obsessed and love helping people.</li><li>Have a good understanding of Javascript and TypeScript.</li></ul>

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50 determine root causes Jobs found

Senior - Data Engineer

Senior Quality & Reliability Engineer

Environmental Health and Safety (EHS) Manager

Senior Electrical Engineer

Quality Engineer

Associate, Quality Assurance (QMS)

QC Chemist

Senior Microbiology Technician

Sr Officer (Team Member) – Reconciliation

Staff Software Engineer (Auth0)

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50 determine root causes Jobs found

Senior - Data Engineer

Senior Quality & Reliability Engineer

Environmental Health and Safety (EHS) Manager

Senior Electrical Engineer

Quality Engineer

Associate, Quality Assurance (QMS)

QC Chemist

Senior Microbiology Technician

Sr Officer (Team Member) – Reconciliation

Staff Software Engineer (Auth0)

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

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TALENT

COMPANY

Contact Us

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