QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

Docusign Developer

QC Laboratory Manager

Senior QA Automation Engineer

Continuous Improvement Lead

Associate Consultant

Director, Engineering Services

Release Manager

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: 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>

Responsibilities: <ul><li>Design, develop, and maintain integrations with DocuSign CLM+ and eSignature APIs.</li><li>Implement and customize contract lifecycle management workflows.</li><li>Develop robust backend components using Java and C# to support business logic and integrations.</li><li>Work with XML and XSLT for document transformations and data interchange.</li><li>Build and manage stored procedures, packages, and triggers using Oracle PL/SQL.</li><li>Utilize Eclipse for Java development and Visual Studio for C# development.</li><li>Configure and support CI/CD pipelines using Azure DevOps.</li><li>Collaborate closely with business analysts, architects, QA, and infrastructure teams.</li><li>Troubleshoot and resolve integration and application issues across environments.</li><li>Create and maintain technical documentation and contribute to best practices.</li></ul> Requirements: <ul><li>8+ years of experience in enterprise application development.</li><li>Proficiency with DocuSign CLM+ (contract templates, workflow design, API integration).</li><li>Strong experience with DocuSign eSignature API and embedded signing flows.</li><li>Solid programming skills in Java and C#.</li><li>Expertise in XML and XSLT for document parsing and transformation.</li><li>Strong knowledge of Oracle Database and PL/SQL development.</li><li>Experience using Eclipse IDE and Visual Studio for software development.</li><li>Hands-on experience with Azure DevOps for version control, CI/CD pipelines, and environment management.</li><li>Strong analytical, communication, and problem-solving skills.</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>

Responsibilities: <ul><li>Together with the team of developers handle the product quality.</li><li>Lead and manage the automation testing efforts and deliverables.</li><li>Plan and prioritize testing activities.</li><li>Maintain and improve an existing test automation framework.</li><li>Develop automation tests for API and UI.</li><li>Execute, maintain and update automation tests.</li><li>Review and analyze tests execution results.</li><li>Maintain all related test documentation.</li><li>Prepare testing data.</li><li>Proactively acquire and clarify requirements as necessary.</li><li>Mentor less skilled teammates and newcomers.</li></ul> Requirements: <ul><li>Strong knowledge of OOP (understanding OOP in automation).</li><li>Excellent knowledge of automation testing principles.</li><li>Excellent knowledge of web-based application structure.</li><li>Excellent knowledge of Python programming language.</li><li>Expert in REST API testing.</li><li>Experience in UI testing.</li><li>Wide experience in developing automation testing frameworks.</li></ul>

Responsibilities: Program Development &amp; Strategy: <ul><li>Design and implement a holistic Continuous Improvement framework tailored to the Talent Hub’s global operations which enhances the existing foundation</li><li>Define revised vision, roadmap, and priorities aligned with business goals and transformation initiatives</li><li>Ensure that Lean principles, a CI mindset and agility are embedded into the DNA of the Talent Hub to drive performance and cost efficiency.</li></ul> Culture &amp; Capability Building: <ul><li>CI mindset across all functions and teams within the AUT Talent Hub including Integrated Service Excellence &amp; Business Analytics.</li><li>Develop and deliver in collaboration with the our client Practitioners and Experts training programs, workshops/Kaizen Events as well as coaching to build strong CI capabilities.</li></ul> Requirements: <ul><li>MBA with focus on Supply Chain, Operations or Quality from a Tier-1 Institute (like IIMs/ IITs/ NITs/ Nittie/ SP Jain, etc.)</li><li>3-5 years of work experience in Supply Chain, Operations or Continuous Improvement roles&nbsp;</li><li>Proven experience with Lean principles</li><li>Certification in Lean, Six Sigma or similar preferred</li><li>Excellent communication and stakeholder engagement skills.</li><li>Strong analytical, facilitation and change management skills&nbsp;</li><li>Experience in global/matrixed environments</li><li>Very deep knowledge on Supply Chain Management Processes</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>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself 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>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>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Responsibilities: Release Planning &amp; Scheduling: <ul><li>Own and maintain the release calendar across multiple teams and products.</li><li>Coordinate release scope, schedule, and delivery milestones with Technology, Delivery &amp; DevOps teams.</li><li>Facilitate Go/No-Go meetings and manage release checklists and criteria.</li></ul> Execution &amp; Deployment: <ul><li>Oversee end-to-end deployment processes for Dev, QA, and Production environments.</li><li>Track cross-team dependencies ensuring seamless coordination of integration &amp; deployment activities.</li><li>Ensure successful builds and deployments through coordination with DevOps and QA.</li><li>Support rollbacks, hotfixes, and emergency patches when necessary.</li></ul> Quality &amp; Risk Management: <ul><li>Ensure that release artifacts (test results, deployment gameplan, rollback plans) are properly documented.</li><li>Track and mitigate risks associated with code deployment and environment readiness.</li><li>Oversee progressive delivery strategies such as canary releases, blue-green deployments and feature toggles ensuring controlled rollouts.</li><li>Collaborate with Security and Compliance stakeholders to meet audit and governance standards.</li></ul> Reporting &amp; Communication: <ul><li>Provide timely and clear status updates to technical &amp; non-technical stakeholders.</li><li>Document release notes for business and technical audiences.</li><li>Act as the central point of contact for release-related escalations and issue resolution.</li><li>Collaborate with Scrum Masters to align sprint deliverables to release timelines.</li><li>Problem-solving mindset with a calm approach under pressure.</li><li>Strong attention to detail and focus on process improvement.</li></ul> Requirements: <ul><li>Bachelor’s degree in computer science, Engineering, Information Systems, or equivalent.</li><li>4 years of experience in Release Management, Configuration Management, or a related field.</li><li>Strong understanding of Agile/Scrum and CI/CD best practices.</li><li>Proficiency with tools such as Jira, Confluence, Jenkins, Argo CD.</li><li>Experience managing releases in cloud-native or hybrid environments.</li><li>Excellent organizational and coordination abilities.</li></ul>

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19 embedded qa Jobs found

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

Docusign Developer

QC Laboratory Manager

Senior QA Automation Engineer

Continuous Improvement Lead

Associate Consultant

Director, Engineering Services

Release Manager

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19 embedded qa Jobs found

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

Docusign Developer

QC Laboratory Manager

Senior QA Automation Engineer

Continuous Improvement Lead

Associate Consultant

Director, Engineering Services

Release Manager

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.