Quality Associate I

Salesforce Developer

Senior Manufacturing Engineer

Compounding Technician

Filling Technician

QE Specialist

Supv III Customer Service

Senior Electrical Engineer

Quality Engineer

Associate, Quality Assurance (QMS)

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>Collaborate with Product Managers and cross-functional teams to understand business requirements and translate them into technical solutions on the Salesforce platform.</li><li>Design, develop, and implement custom Lightning Web Components (LWC) on the client-side and leveraging object-oriented design principles and best practices for back-end.</li><li>Create and maintain Apex classes, triggers, and other Salesforce development artifacts.</li><li>Customize and extend standard Salesforce functionality to meet unique business needs.</li><li>Troubleshoot and resolve issues for our Salesforce end users while identifying any root cause problems to prevent future issues.</li><li>Develop, maintain, and extend integrations built on the Force.com platform.</li><li>Collaborate with front-end components to integrate Salesforce applications with external systems and web services.</li><li>Perform unit testing, code reviews, and participate in the overall quality assurance process.</li><li>Apply solid understanding and working knowledge of modern JavaScript for Lightning Web Components to solve for complex business needs.</li></ul> Requirements: <ul><li>Bachelor’s degree in Computer Science, Information Technology, Information Systems or related field</li><li>Salesforce Certified (e.g., Platform Developer I, Platform Developer II, JavaScript)</li><li>2+ years of experience with SF Command Line tooling, Git, and VS Code</li><li>2+ years of experience with Apex, Visualforce, and other Salesforce development technologies</li><li>2+ years of Proven experience as a Salesforce Developer with a focus on Lightning Web Components (LWC)</li><li>3+ years of experience and strong proficiency in object-oriented design principles and hands-on experience in applying them to Salesforce development.</li></ul>

Responsibilities: <ul><li>Lead a dedicated team of engineers and technicians within the Projects or Manufacturing group.</li><li>Ensure that engineers are fully integrated into the overall project team and production support activities.</li><li>Plan and implement training and development programs for direct reports.</li><li>Complete process design and development projects by training and guiding technicians.</li><li>Provide coaching and mentorship to team members.</li><li>Establish engineering goals and objectives aligned with business plans.</li><li>Identify and implement effective, permanent technical and system solutions to problems.</li><li>Consistently meet customer requirements, performance expectations, and deadlines.</li><li>Prepare product and process reports by collecting, analyzing, and summarizing information and trends.</li><li>Champion compliance with internal systems and processes.</li><li>Identify and develop improvements to enhance Service, Delivery, Quality, and Cost metrics using Lean/Six Sigma methodologies.</li><li>Research advanced process technologies and evaluate potential competitive advantages and cost benefits.</li><li>Lead or guide a portfolio of engineering projects in collaboration with cross-functional teams (e.g., NPI, quality engineering, design assurance, R&amp;D).</li><li>Collaborate with teams to plan, coordinate, and implement activities supporting the successful launch of new products, including make/buy analysis, new process introduction, and more.</li><li>Develop or modify manufacturing processes by studying product requirements and designing, modifying, or testing manufacturing methods and equipment.</li><li>Maintain professional and technical knowledge through workshops, publications, networking, and participation in professional societies.</li><li>Manage external relationships with key technology suppliers.</li><li>Oversee workload distribution among engineers and technicians to meet operational and business priorities.</li></ul>&nbsp;Requirements: Education &amp; Experience <ul><li>Bachelor’s degree or equivalent in an Engineering field with 5–10 years of experience in a demanding high-volume production environment or a high-mix, low-volume environment.</li><li>Experience in medical devices or similar regulated manufacturing and quality systems is essential.</li><li>Proficiency with CAD tools; SolidWorks preferred.</li><li>Experience using Minitab, MS Project, and advanced Excel.</li><li>Demonstrated ability to lead a production-focused team, drive technical problem solving, and manage line setup including equipment acquisition and process development.</li><li>Working knowledge of Lean and/or Six Sigma engineering principles with proven results.</li><li>Statistical knowledge, including data analysis and statistical software (JMP, Minitab, etc.).</li><li>Lean Six Sigma Green Belt certification preferred.</li><li>Excellent communication, planning, and organizational skills.</li><li>Self-motivated with strong decision-making abilities.</li><li>Willingness to work independently and to take on an international assignment of up to 3 months.</li><li>Fluent in English (written and verbal), &gt;80% proficiency.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</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>As a Manager in Solution Center, you will be at the forefront of driving transformational strategies focused on creating exceptional customer experiences.</li><li>Your leadership will be pivotal in establishing our brand as the preferred supplier by fostering strong customer relationships and steering your team towards unparalleled service excellence and growth.</li></ul> Responsibilities: <ul><li>Lead with Accountability: Spearhead your team to achieve specific departmental goals, focusing on delivering a superior Customer Experience.</li><li>Cultivate Customer Relationships: Empower your team to enhance and expand customer engagement.</li><li>Talent Acquisition and Development: Recruit and nurture top talent, building a team that embodies our vision and drives organizational transformation.</li><li>Champion of Change: Lead by example in adopting transformation initiatives and fostering a culture of positive change.</li><li>Operational Excellence: Instill a mindset of continuous improvement, enhancing team efficiency and service quality.</li><li>Career Development: Offer opportunities for team growth and development, preparing them for future career advancements.</li><li>Cross-Functional Collaboration: Work seamlessly with internal partners in different BU’s, engineering, planning, and sales to ensure comprehensive customer support.</li></ul> Requirements: <ul><li>Experience in a shared service environment.</li><li>Stake Holder management experience</li><li>Track record of successful change management in Customer Care.</li><li>Leadership experience in large, multi-layered teams.</li><li>8 + years in multinational Customer Care operations, with at least 5 years in a relevant role.</li><li>Effective collaboration across all organizational levels.</li><li>Industry-specific experience is advantageous.</li><li>Exceptional communication skills.</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: <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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32 assurance Jobs found

Quality Associate I

Salesforce Developer

Senior Manufacturing Engineer

Compounding Technician

Filling Technician

QE Specialist

Supv III Customer Service

Senior Electrical Engineer

Quality Engineer

Associate, Quality Assurance (QMS)

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32 assurance Jobs found

Quality Associate I

Salesforce Developer

Senior Manufacturing Engineer

Compounding Technician

Filling Technician

QE Specialist

Supv III Customer Service

Senior Electrical Engineer

Quality Engineer

Associate, Quality Assurance (QMS)

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

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Contact Us

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