Quality Assurance (QA) Associate

Mechanical Maintenance Engineer - Automation Technology

EHS Analyst

DEA Manager

Associate, Quality Assurance (QMS)

Manager, Industrial and Employee Relations

Manufacturing Team Leader

Facility Mechanic

QA Tester

Environment Health and Safety Engineer

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: This position is responsible for mechanical maintenance and assembling automation systems in the manufacturing. <ul><li>Maintenance work on mechanical, electronic and pneumatic systems, including inspections, cleanings and lubrications.</li><li>Creation of machine safety concepts and machine data concepts.</li><li>Design and optimization of automation solutions for production plants using PLC controllers, robotics, industrial image processing, drive technology, testing technology, safety technology and other automation technologies.</li><li>Programming and commissioning of PLC controllers, safety controllers and HMI systems.</li><li>Mechanical design, assembly and wiring of machines and plants.</li><li>Integration of robotic systems and other automated components into existing production processes.</li><li>Functional tests and performance tests on automation systems, troubleshooting and optimization of control programs.</li><li>Preparation of technical documentation, operating instructions and training material.</li><li>Collaboration in planning and implementing projects for modernization and expansion of our production facilities.</li><li>Support in training of new employees in using new automation technologies.</li><li>Introduction of Industry 4.0 technologies (such as 3D printing, AMR, predictive maintenance, simulation, ).</li></ul> Requirements: <ul><li>Bachelors Degree in preferably mechanical engineering, automation engineering, mechatronics or a similar qualification.</li><li>Min 3 years of experience in industrial automation.</li><li>Knowledge of Cam-controlled machines like: Bihler (prefered), Wafios, Finzer.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</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: Grievance &amp; Compliance Leadership: <ul><li>Lead end-to-end employee misconduct investigations (preliminary and detailed), ensuring fairness, consistency, and legal compliance across all cases.</li><li>Own full disciplinary lifecycle: recommend actions, approve issuance of show cause/warning/dismissal letters, and maintain robust, auditable records.</li><li>Drive periodic compliance audits across contract labor suppliers (security, canteen, uniform vendors) and ensure timely corrective action on non-conformities.</li><li>Conduct due diligence and performance reviews of foreign operator agencies; submit data-driven recommendations for contract renewals or terminations.</li></ul> Policy &amp; Process Ownership: <ul><li>Manage centralized document control for all HR policies, procedures, and operational guidelines — ensuring accessibility, version control, and alignment with evolving legal standards.</li><li>Design and deliver compliance training programs for managers and employees, covering HR policy, performance management, and labor law essentials.</li><li>Act as the go-to subject matter expert on employment law, IR best practices, and grievance resolution frameworks.</li></ul> Union Engagement &amp; Strategy: <ul><li>Lead plants transition into a unionized environment: educate leaders and HR on union dynamics, negotiation frameworks, and collaborative engagement models.</li><li>Build and sustain a constructive union relationship — balancing business needs with employee representation through regular dialogue, transparency, and mutual respect.</li><li>Anticipate union-related risks and opportunities; advise leadership proactively on IR positioning and response strategies.</li><li>Drive union readiness programs, including leadership coaching, communication protocols, and scenario planning.&nbsp;</li></ul> Canteen Management: <ul><li>Lead vendor governance for contract labor and canteen operations. Monitor service levels, hygiene, and employee satisfaction; drive timely audits, feedback loops, and improvements.</li></ul> Hostel &amp; Foreign Worker Management (End-to-End): <ul><li>Manage full lifecycle of foreign worker operations: manpower planning, documentation, immigration processes, hostel inspections, welfare coordination, and compliance with regulatory and internal standards.</li><li>Ensure foreign workers are treated with dignity and respect; champion human rights standards and ethical labor practices.</li><li>Coordinate with embassies, Ministry of Home Affairs, Department of Immigration, and labor agencies to ensure seamless processes and timely resolution of issues.</li><li>Oversee hostel living conditions, safety, and welfare programs; act as the primary point of contact for foreign worker concerns.</li></ul> Compliance Audits &amp; Risk Management: <ul><li>Lead and coordinate audits related to labor compliance, human rights, and ethical sourcing across all third-party providers.</li><li>Ensure the plant is audit-ready at all times; track and close findings with urgency and rigor.</li><li>Stay current on evolving labor regulations and proactively adjust policies and practices to mitigate risk</li></ul> Requirements: <ul><li>Bachelors degree in Human Resource Management, Business Administration, Industrial Relations, or related discipline.</li><li>7–10 years of HR experience, with deep exposure to industrial relations, employee relations, labor law, and HR compliance—preferably in a manufacturing, unionized, or FMCG environment.</li><li>Proven track record of managing complex disciplinary cases, union negotiations, and IR matters with sound judgment and integrity.</li><li>Strong working knowledge of Malaysian labor law, Employment Act, Industrial Relations Act, and related regulations.</li><li>Advanced proficiency in Microsoft Office (Excel, Word, PowerPoint); able to prepare reports, dashboards, and present findings with clarity.</li><li>Familiar with HR systems, documentation best practices, and audit standards.</li><li>Excellent stakeholder management and interpersonal skills; able to influence, negotiate, and build trust across all levels—from frontline employees to senior leaders.</li></ul>

Responsibilities: <ul><li>Assist and monitor employees in job performance, answer questions, maintain action log, and provide&nbsp;</li><li>input to Area Lead on employee’s job performance.</li><li>Maintain production schedules by ensuring that each line is set-up per the prescribed line layout, has proper equipment, fixturing, tools, proper prints, in-process inspection sheets, and work instructions at the beginning of each shift, after line changeover, and during the shift.</li><li>Ensure proper clean up.</li><li>Ensure proper operation and guarding of equipment, report any unsafe equipment and/or unsafe acts.</li><li>Set good examples for quality, attendance, confidentiality, professionalism and display a positive attitude.</li><li>Consistently apply the Quality System procedures and enforce company policies and safety regulations.</li><li>Complete all documentation as required by department work instructions.</li><li>Ensure all suspect or reject material is quarantined and handled per Quality System procedures.</li><li>Make decisions and accept responsibility on operations related to assigned lines.</li><li>Assist in performing and evaluating 1st piece inspections for products as directed.</li><li>Post quantity goals and turn goal results in to Area Lead</li><li>Promote teamwork within the Production Line</li><li>Work closely with production control to react to schedule changes.</li><li>Communicate all appropriate issues to Area Lead.</li><li>Ensures production paper work is processed in a timely and accurate manner.&nbsp;</li><li>Perform other related duties and assignments as required.</li></ul> Requirements: <ul><li>High School diploma or GED</li><li>Evidence of continued education &amp; training</li><li>3-12 months experience in production</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Responsibilities: <ul><li>Develop detailed test plans based on project requirements and specifications.&nbsp;</li><li>Provide feedback on quality standards, usability, and areas for improvement.</li><li>Automates test scenarios and expected outcomes.&nbsp;</li><li>Conduct regression, integration, user acceptance, and performance testing.</li><li>Conducts comprehensive testing and risk-based assessments of the testing objects.&nbsp;</li><li>He/She uses source documentation as input and contributes to the planning and implementation of testing activities.&nbsp;</li><li>Leads testing components of large and complex projects, assigns tasks, provides direction to resources, and reports progress to project stakeholders.&nbsp;</li><li>He/She creates and selects tools and methodologies for review and approval by management.</li></ul> ﻿Requirements: <ul><li>Bachelors Degree or International equivalent&nbsp;</li><li>Bachelors Degree or International equivalent in Computer Science, Information Systems, Mathematics, Statistics or related field - Preferred&nbsp;</li><li>comprehensive knowledge of technical skills, principles, practices, and procedures of testing methodologies and working knowledge in planning, designing, and conducting QA reviews and inspections.&nbsp;</li><li>He/She provides expertise for key business functions and supporting technologies.&nbsp;</li><li>Provides mentorship and expertise in technologies and processes for Information Services Management (ISM) and Quality Assurance (QA).&nbsp;</li><li>He/She maintains an awareness of emerging technologies to ensure a competitive advantage.</li><li>Experience with both web and client/server based testing</li><li>Minimum 8 Years of Relevant Experience in IT Test Automation.</li><li>Should have strong Mainframe testing [CICS, JCL, DB2, Cobol]</li><li>Must be able to test and debug batch jobs (JCL).</li><li>Must be able to perform backend testing by executing SQL queries.</li><li>Expertise in APIs &amp; Web Services testing</li><li>Hands-on experience in Selenium, TestNG and Cucumber frameworks</li><li>Good in test execution reporting skills</li><li>Expertise in Test Cases Design and Test Data management</li><li>Expertise in tools like PostMan, SOAP UI, WinSCP, Oracle, Jenkins, GitHub and AppDynamics.</li><li>Should be well versed with Agile testing and Continuous Testing</li><li>Experience with Test Management tools</li><li>Knowledge on AZURE DEVOPS&nbsp;</li><li>Understanding of SAFe Agile methodologies</li><li>Should be solution-oriented and have problem solving aptitude</li><li>Should have excellent communication and presentation skills</li><li>Knowledge on Logistics domain will be an advantage</li><li>Good to have Performance Testing experience.</li><li>Knowledge on JMeter / Performance center will be an advantage.</li><li>Any certifications in test automation</li></ul>

Responsibilities: <ul><li>EHS Operation - undertaking the role and act as Workplace Safety Health Officer /Fire Safety Manager / Permit Holder for Regulated Chemical.</li><li>EHS Compliance and Audit - Internal auditor for ISO14001 Environmental Management System, ISO 45001 Safety &amp; Health Management System, ISO 50001 Energy Management System and RBA Responsible Business Alliances.</li><li>Enforce EHS rules and regulations by developing procedures and controls in Environmental Health and Safety Management System for all to comply.</li><li>Drive &amp; implement Chemical Safety, Waste handling Management System in Company.</li><li>Plan and organize EHS awareness activities, campaigns by working closely with the WESH committee members.</li><li>Perform EHS inspections with WESH committee teams as well as carry out regular EHS related orientation/training and audits.</li><li>Maintain EHS emergency response plan and conduct the necessary EHS trainings and drills.</li><li>Implement Aspect/Impact, Hazard/Risk Assessment and Permit-To-Work</li><li>Review latest corporate requirements/Legal Regulations/Act and code of practice and assess with respective operations to determine suitability and compliance.</li><li>License holder for Flammable Material, Hazardous Substance, Explosive Pre-cursor and Fire Safety Manager for the Factory as required by Local Authorities.</li><li>Manage development and implementation of both tactical and strategic Process Safety Management (PSM).</li><li>Perform any other duties as assigned.</li></ul> Requirements: <ul><li>Min. 2 years working experience in electronic or wafer manufacturing related environment.</li><li>Certified and registered Workplace Safety and Health Officer (WHSO), Fire Safety Manager Cert, HAZMAT knowledge/experience is an added advantage</li><li>Certified ISO 45001, ISO 14001, ISO50001 Lead / Internal Auditor with prior auditing experience. Hands on experience with management system administration is added advantage.</li><li>Degree /Diploma in mechanical, chemical, electrical or EHS</li></ul>

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13 inspections Jobs found

Quality Assurance (QA) Associate

Mechanical Maintenance Engineer - Automation Technology

EHS Analyst

DEA Manager

Associate, Quality Assurance (QMS)

Manager, Industrial and Employee Relations

Manufacturing Team Leader

Facility Mechanic

QA Tester

Environment Health and Safety Engineer

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13 inspections Jobs found

Quality Assurance (QA) Associate

Mechanical Maintenance Engineer - Automation Technology

EHS Analyst

DEA Manager

Associate, Quality Assurance (QMS)

Manager, Industrial and Employee Relations

Manufacturing Team Leader

Facility Mechanic

QA Tester

Environment Health and Safety Engineer

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