Mechatronics Engineer

Quality Associate I

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

QC Laboratory Manager

Associate Consultant

Project Engineer 

Software Engineer, Quality Analyst

Quality Control Supervisor

Role Description: <ul><li>The Position has been created to lead a team of Mechanical Designers, Electrical Automation Engineers and Technicians of the Operations team to define the process and build the machines needed to make the new products in line with the strategy map and market demand.</li></ul> Responsibilities: <ul><li>Responsible for working with a team of engineers for new project launches. Coordination with different technology leads connected with new projects. Collaborating with ME, OPS, AQE, NPI and PLTL team for execution of all new projects as per agreed APQP timelines.</li><li>Responsible for execution of PLTL projects and adherence to launch sheet requirements.</li><li>End to End responsible for capturing the voice of Customers and All Stakeholder requirements of the product to meet the expectations</li><li>Act as a purposeful bridge between ME and operations.</li><li>Work closely with project management and NPI procurement for capacity and streamlined supplies&nbsp;</li><li>Identify safety, quality and cost saving opportunities on new and existing projects.</li></ul> Requirements: <ul><li>Technical Degree/Diploma in Mechatronics - NTTF/BE</li><li>Hands own experience assembly of machines and troubleshooting</li><li>1 to 4+ years of experience working in medium or large matrix organizations.&nbsp;</li><li>Hands on Experience in designing and building Complex and high precision machines, high accuracy assembly automation machines for Automotive or electronics industries</li><li>Experience in Robot programming.</li><li>Vision inspection and testing machines like leakage testers and electrical testers experience&nbsp;</li><li>PLC and HMI Programming, Servo programming and tuning, and trouble shooting</li><li>Updated knowledge on current Programming Software and Design Software.</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>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>

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>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Role Description: <ul><li>We are looking for Associate Consultants to join a major Platform Operations workstream in Bangalore.</li><li>The focus will be on enabling and assisting the Customer Platform Operations team to manage and operate a newly deployed Red Hat OpenShift Virtualization (OCP Virt) platform in a production environment.</li><li>The consultants will be embedded in the Platform Operation Track, working side-by-side with the customer team to provide operational support, knowledge transfer, and daily assistance with Day 2 tasks.</li></ul> Responsibilities:&nbsp; <ul><li>Support the deployment, operation, and management of the Red Hat OpenShift Virtualization platform in production.</li><li>Assist the Customer Ops team with daily operational tasks and troubleshooting.</li><li>Enable the Ops team to: o Resolve minor issues independently (requiring strong OCP/OCP Virt knowledge).</li><li>Correctly identify significant issues and escalate support cases with the necessary details for fast resolution.</li><li>Share best practices, operational guidelines, and documentation to strengthen the Ops team’s capabilities.</li><li>Contribute to the long-term stability and scalability of the platform.</li></ul> Requirements: Required Skills &amp; Experience&nbsp; <ul><li>Strong, hands-on experience with Red Hat OpenShift and OpenShift Virtualization (OCP Virt).</li><li>Good understanding of containerized environments, Kubernetes, and platform operations.</li><li>Ability to provide operational support and knowledge transfer to customer teams.</li><li>Strong problem-solving skills and familiarity with Day 2 operational tasks.</li><li>Good communication skills to work effectively in customer-facing, collaborative environments.</li></ul>

Responsibilities: <ul><li>Direct new project development activities from definition phase to mass production phase to achieve cost and product launch targets. Coordination of problems solving and recommendations with appropriate engineering and manufacturing groups, marketing personnel, or CTL or PM. Mainly to organize the project from G3-G6 refer to Product Portfolio Lifecycle Management procedure.</li><li>Possesses and applies directly or through leadership of personnel, comprehensive knowledge of Engineering Practices and Procedures, including extensive understanding of manufacturing technologies such as stamping, plating, molding, and assembly processes.</li><li>Take on program management responsibilities for localization and product transfer of products into the plant from affiliate companies.</li><li>Involve establishing project plan and co-ordinate data input in company projects &amp; APQP and track progress to ensure project targets and datelines are met.</li><li>Prepare business case justification on technical capability, production capacity requirement, tooling and equipment investment requirement.</li><li>Prepare master schedule plan for pre-production/ Run @ Rate and mass production tool up and follow up till successful completion. Ensure projects are completed according to project milestone and plans.</li><li>Co-ordinate and follow-up on machine, mold and dies tool-up from sample making for customer qualification and approval, to mass production capability status.</li><li>Resolve all issues related to the project will team members and suppliers.</li><li>Maintains current knowledge of relevant new technologies, materials, equipment, industry and market trends, and competitive products through literature, seminars, courses, etc. Applies this knowledge to determine needs and opportunities to develop new products or improve existing products.</li><li>Supports IATF16949 quality programs as well as ISO14000 environmental programs. Provides and allocates resources for their successful implementation.</li><li>Ensure overall plan and day to day activities of project management is in line with company corporate policies.</li><li>Support project Kaizen, IE-task and any assignment from direct Supervisor/ Manager.</li></ul> Requirements: <ul><li>5-10 years working experience in a manufacturing environment.</li><li>3-5 years experience with project engineering &amp; project management, preferable in automotive industry.</li><li>Working knowledge of project management tools, QA tools, SAP, APQP, PPAP, PPMEA, VDA 6.3 and IATF16949.</li><li>Leadership qualities with ability to work with all levels of staff within the organization and with suppliers.</li><li>Manage the project risk and action with cross functional team, strong understanding of how to deliver a systematically robust quality outcome.</li><li>Manage on implementation of tooling, equipment, material flow, layout and work instruction to production.</li><li>Knowledge of project development costs are controlled and manage for profitability.</li><li>Process improvement, IE-technical, Kaizen, Six Sigma, and Lean Manufacturing.</li></ul>

Responsibilities: <ul><li>Understand the test requirements and getting the team aligned with the same.&nbsp;</li><li>Participating on all technical aspects, interacting with client for all technical inputs and queries.&nbsp;</li><li>Automation and integration of complex processes.&nbsp;</li><li>Work closely with the development team on becoming the SME of the product.&nbsp;</li><li>Strong Testing Fundamentals , testing tools, reporting and frameworks.&nbsp;</li><li>Build and maintain the automation regression suite for the white box testing of the products.&nbsp;</li><li>Participate in requirement grooming and think form end customer perspective.&nbsp;</li><li>Should own all aspects of Testing, QA Framework for existing Products and Product end-to-end testing across functional, Security and Automation.&nbsp;</li><li>Work in a dynamic Agile environment and come up with solutions to meet project needs.&nbsp;</li><li>Communicate with Client and end customers in written and verbal.&nbsp;</li><li>Should be able to interact with client and customers for Escalated Customer Issues/Bugs.&nbsp;</li></ul> ﻿Requirements: <ul><li>Manual/Automation Testing - DataCom (Networking , Security, L2-L3, L4-L7 Protocols)&nbsp;</li><li>Hands on experience on Networking products Switch Router and Firewall&nbsp;</li><li>Good testing experience in Datacom/IP-Networking/Switching/routing domain.&nbsp;</li><li>Knowledge of Networking (L2/L3 protocols)&nbsp;</li><li>Knowledge of Testing tools : IXIA/SPIRENT&nbsp;</li><li>Security testing tool - Nessus, OpenVas, Achilles, Defensics (Anyone)&nbsp;</li><li>preferably knowledge / hands on in traffic generation tools such as IXIA or Spirent,&nbsp;</li><li>Performance and scalability testing, security, Penetration testing. packet sniffing tools.&nbsp;</li><li>Linux/containers Knowledge&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.&nbsp;</li><li>CI/CD: Jenkins, GitHub, Bitbucket Actions&nbsp;</li><li>Scripting: Python and/or Shell is a must&nbsp;</li><li>Working experience in Routing protocols such as RIP, OSPF, BGP, MPLS VRRP&nbsp;</li><li>Good understanding of Management interface such as SNMP, Web, Yang, Netconf, Rest based interfaces etc&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li><li>Strong written and oral communication skills.&nbsp;</li><li>High levels of motivation with a can-do attitude.&nbsp;</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

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13 embedded qa Jobs found

Mechatronics Engineer

Quality Associate I

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

QC Laboratory Manager

Associate Consultant

Project Engineer

Software Engineer, Quality Analyst

Quality Control Supervisor

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13 embedded qa Jobs found

Mechatronics Engineer

Quality Associate I

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

QC Laboratory Manager

Associate Consultant

Project Engineer

Software Engineer, Quality Analyst

Quality Control Supervisor

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.