Quality Assurance (QA) Associate

Signavio Business Process Specialist

QA Associate II

International Customer Service Associate

Associate Director RA & QA

Registered Client Service Associate

Production Technician I

Associate Data Engineer

Associate, Quality Assurance (QMS)

Customer Quality Engineer (CQE)

Responsibilities: <ul><li>With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.</li><li>Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.</li><li>Support Drug Product Recall/Field alert management.</li><li>Assist with review of Quality Agreements.</li><li>With supervision, review deviations/investigations related to our client frontend products.</li><li>Assist with SOP management for our client US corporate office.</li><li>Support with quality matters for disposition of product returns.</li><li>Assist during FDA inspections and local regulatory inspections at our client US corporate office.</li></ul> Requirements: <ul><li>Excellent verbal and written communication skills are necessary.</li><li>With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.</li><li>Motivated, results driven with attention to detail, accuracy and clarity.</li></ul> Qualifications: <ul><li>BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.</li><li>Recent graduates will be considered for this role.</li></ul>

Responsibilities: ﻿Process Modelling &amp; Transformation <ul><li>Lead end-to-end business process design, modeling and optimization in Signavio across core SAP modules.</li><li>Build &amp; maintain process architecture, SIPOC, EPC, BPMN 2.0 based process maps and process hierarchies.</li><li>Conduct enterprise-wide process discovery, gap analysis, harmonization, and standardization initiatives.</li></ul> Requirements: <ul><li>8–15 years of experience.&nbsp;</li><li>Chennai location with a hybrid work model.</li><li>Minimum 4 years of hands-on SAP Signavio experience.</li><li>Strong implementation, configuration, and rollout project exposure.</li><li>Individual Contributor (IC) role reporting to the Associate Director.</li><li>Understand Business Processes.</li><li>Create Process Maps in SAP Signavio.</li><li>Improve Existing Processes.</li><li>Support SAP S/4HANA Transformation.</li><li>Work on Process Mining.</li><li>Create Dashboards &amp; KPIs.</li><li>Process Governance.</li><li>Master Data &amp; Exalca Integration 9. Stakeholder Management.</li><li>User Training &amp; Change Management.</li></ul>

Role Description: <ul><li>The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities.</li><li>Communicates to multiple departments and supervision to provide timely process and issue updates.&nbsp;</li><li>Identifies and escalates issues or problems to appropriate supervision.</li><li>Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement</li></ul> Responsibilities: <ul><li>Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.</li><li>Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.</li><li>Is competent in all relevant processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams &amp; Ointments Mfg. and Batch Transfer, Packaging, etc.) Follows internal processes related to controlled substances.</li><li>Performs GMP-related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures</li><li>Actively participates in process validation and equipment qualification activities.</li><li>May execute computer data entries in SAP, Leucine, LIMS, and department databases.</li><li>Sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes.</li><li>Performs manufacturing/packaging stage reviews of batch records.</li></ul> Requirements: <ul><li>High school diploma or equivalent with 4-7 years’ relevant experience OR</li><li>AA/AS degree with 3-6 years’ relevant experience OR</li><li>BA/BS degree with 2 -5 years’ relevant experienceRelated discipline and certification in assigned area a plus.</li><li>Experience with statistical sampling methods a plus.</li></ul> Knowledge &amp; Skills <ul><li>Attention to detail.</li><li>Strong documentation skills.</li><li>Ability to read and interpret SOPs and function within the scope of procedures.</li><li>Proficiency with basic math skills and basic experience with computers and software applications required.</li><li>Ability to learn new processes and procedures.</li><li>Able to communicate effectively with other departments, management and operational personnel.</li><li>Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).</li><li>Proof-reading skills; ability to identify errors.</li><li>Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs).</li><li>Experience with Enterprise Resource Planning (ERP) system is a bonus.</li><li>Ability to work overtime as needed, including occasional weekend shifts.</li></ul> Physical Requirements <ul><li>Lift 15 lbs.</li><li>Walk across plant/warehouse.</li><li>Wear appropriate gowning as required.</li><li>Ability to read for extended periods of time.</li></ul>

Responsibilities: <ul><li>Provides dedicated support to International shippers, primarily supporting US operations, ensuring a seamless customer experience.</li><li>Analyzes and resolves Preferred account issues, taking full end-to-end ownership of each case until final resolution.</li><li>Focuses on First Call Resolution by effectively navigating systems, identifying root causes, and coordinating solutions across functions.</li><li>Builds and maintains strong relationships with internal partners (e.g., Billing, Delivery Information, Operations, Brokerage) to facilitate timely and effective issue resolution.</li><li>Develops and maintains trusted relationships with external customers through a strong customer-focused approach and proactive communication.</li><li>Connects the dots across processes, systems, and teams to identify gaps, prevent repeat issues, and drive sustainable solutions.</li><li>Demonstrates out-of-the-box thinking when resolving non-standard or complex customer scenarios.</li><li>Maintains a strong customer advocacy mindset, balancing internal requirements with external customer expectations.</li><li>Makes outbound calls and follow-as needed to ensure clear communication and customer satisfaction throughout the resolution process.</li></ul> Requirements: <ul><li>High school diploma, GED, or international equivalent</li><li>Strong English oral and written communication skills, with the ability to communicate clearly with both internal and external customers</li><li>Strong problem-solving and analytical skills, with the ability to think holistically across end-to-end processes</li><li>Proven customer focus, with the ability to build and maintain effective working relationships with customers and internal stakeholders</li><li>Ability to navigate multiple systems and tools efficiently</li><li>Demonstrated ownership mindset and accountability for results</li><li>Previous customer service experience</li><li>Experience supporting International or US-based operations is an asset</li></ul> Additional Comments: <ul><li>The role will be based in Chennai.</li><li>US working hours required</li></ul>

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Responsibilities: <ul><li>Assist advisor(s) in servicing clients including preparing financial plans, conducting investment research and completing trades and transactions as described by the advisor.</li><li>Prepare and summarize client meetings by scheduling and confirming meetings, entering data into contact manager, building the agenda and summary of meetings, escorting clients to advisor meeting and providing vital follow-up.</li><li>Ensure new business paperwork is submitted efficiently which includes preparation of forms and documentation for submission to home office, acquisition of appropriate signatures, tracking of new insurance applications and coordination of rollovers.</li><li>Coordinate marketing events which include organizing the event, contacting vendors, finalizing event details, crafting marketing compliance documentation and managing event marketing reimbursement.</li><li>Provide general administrative duties such as answering the advisors’ phone, processing expense management reports, preparing routine client correspondence, supporting closes, setting up client documents and new business correspondence and alerts. </li></ul> Requirements: <ul><li>Bachelors degree or equivalent.</li><li>3 - 5 years relevant experience required.</li><li>Series 7 or ability to obtain within 150 days.</li><li>State securities agent registration (S63 or S66) or ability to obtain within 150 days.</li><li>Experience working in a client service environment.</li><li>Detail-oriented, strong math, and analytical skills. Good organization and time management skills.</li><li>Able to manage multiple priorities and prioritize effectively. Able to independently work with minimal direct supervision.</li><li>Able to communicate with all levels within the organization. Process oriented and can work with a team.</li><li>Strong computer and software skills. Preferred Qualifications:</li><li>State IAR registration (S65 or S66) or ability to obtain within 150 days.</li><li>Life, Accident, and Health licenses &amp; Variable Contracts or ability to obtain within 150 days.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</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>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Responsibilities: <ul><li>Ability to troubleshoot problems in a live environment and provide real time help with critical issues.</li><li>Write code that is easily understood and maintainable by other team members.</li><li>Keep up to date with developments in technologies we are using.</li><li>Ability to communicate and work effectively, supporting various business departments.</li><li>Ability to work in fast-paced interdisciplinary environment.</li></ul> Requirements <ul><li>BA/BS in Computer Science or equivalent practical experience.&nbsp;</li><li>At least 3+ years of post-university experience as a full-stack engineer.</li><li>Solid knowledge of programming fundamentals—algorithms, data structures, design patterns, and paradigms.</li><li>Strong knowledge of Python.</li><li>Solid knowledge SQL and relational databases.</li><li>Knowledge of Extract-Transform-Load (ETL) and big data analytics tools.</li><li>Experience working in a cloud environment (AWS, Azure, GCP).</li><li>Familiarity with popular Python data analytics frameworks.</li><li>Familiarity with Snowflake or other large analytics engines.</li><li>Experience with data warehousing and working in environments with large scale, complex analytics requirements.</li><li>Familiarity with DAG-based job scheduling tools.</li><li>Cloud-native container orchestration platforms and tools.</li><li>Experience working in the Financial Services industry.</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>Serve as the main contact for customer complaints and quality issues—coordinate root cause analysis and corrective actions (8D, CAPA), ensuring robust and timely responses.</li><li>Monitor complaint trends, DPPM, COPQ, warranty returns, and initiate improvement initiatives when necessary</li><li>Investigate internal and supplier quality issues; lead supplier audits, performance evaluations, process audits, and enforce corrective measures</li><li>Review customer contracts and quality requirements (PPM targets, FAI demands, Q-certifications); communicate deviations and ensure alignment across internal teams.&nbsp;</li><li>Conduct onsite visits to customer plants and supplier locations for quality discussions, complaint containment, and relationship building</li></ul> Requirements: <ul><li>Must have experience in the automotive industry (Tier 1 or Tier 2).</li><li>Familiarity with quality management for connectors, harnesses, and cable products is preferred (but not mandatory).</li><li>Approximately 5 years, ideally under 30 years of age, with growth potential.</li><li>Familiarity with customer quality complaint handling processes.</li><li>Proficiency in quality tools (e.g., 8D, 5 Whys, FMEA).</li><li>Preference will be given to candidates with AQE/PQE experience.</li><li>Working proficiency in English is a plus.</li><li>Associate degree or higher; a bachelors degree is preferred.</li></ul>

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15 associate Jobs found

Quality Assurance (QA) Associate

Signavio Business Process Specialist

QA Associate II

International Customer Service Associate

Associate Director RA & QA

Registered Client Service Associate

Production Technician I

Associate Data Engineer

Associate, Quality Assurance (QMS)

Customer Quality Engineer (CQE)

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Location

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15 associate Jobs found

Quality Assurance (QA) Associate

Signavio Business Process Specialist

QA Associate II

International Customer Service Associate

Associate Director RA & QA

Registered Client Service Associate

Production Technician I

Associate Data Engineer

Associate, Quality Assurance (QMS)

Customer Quality Engineer (CQE)

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

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TALENT

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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.