Quality Technician

Manager - Environmental Health & Safety (EHS)

Quality Associate I

QE Specialist

Associate, Quality Assurance (QMS)

QC Chemist

Manager, Site Logistics & Project Integration

Supervisor – Quality & Reliability Engineering

Manager – ADL GMP

Manufacturing Team Leader

Responsibilities: <ul><li>Ensuring products meet internal and external customer requirements.</li><li>Performing regular inspections and tests on raw materials, in-process components, and finished products using measurement equipment (e.g., calipers, micrometers, and gauges).</li><li>Recording inspection results and maintaining detailed quality documentation.</li><li>Identifying defects and reporting findings to supervisors or engineers.</li><li>Assisting Quality Engineers in resolving quality issues within the production operation.</li><li>Supporting root cause analysis and corrective action activities.</li><li>Complying with Health, Safety, and Environmental Policies.</li><li>Contributing to continuous improvement activities and initiatives.</li><li>Writing reports and providing data to management.&nbsp;</li></ul> Requirements: <ul><li>Experience as an Inspection or Quality Technician.</li><li>Understanding of engineering drawings and quality management systems (e.g., ISO9000, TS16949, ISO 17025).</li><li>Knowledge of statistical tools (e.g., Minitab) and data analysis.</li><li>Strong attention to detail, analytical, and problem-solving skills.</li><li>Ability to interpret technical information and work with minimal supervision.&nbsp;</li></ul>

Responsibilities: Planning and Budgeting&nbsp;<ul><li>Initiate and execute annual EHS &amp; S improvement project plan, EHS &amp; S training plan, EHS &amp; S internal audit plan and annual EHS &amp; S budget&nbsp;</li></ul> People Management &amp; Development&nbsp;&nbsp; <ul><li>Allocate and balance work across direct reports, review and provide timely performance feedback to subordinate, coach, guide, develop and motivate them,&nbsp;</li><li>help to resolve functional issues in the team, submit manpower request and interview candidates in order to achieve targeted function performance goal.&nbsp;</li><li>Develop skills of direct reports and others with EHS &amp; S responsibilities in the organization.&nbsp;</li></ul> EHS Structure &amp; Program Management&nbsp; <ul><li>Build action plans for the implementation of the organization’s EHS &amp; S programs and take a leadership role in execution in order to deliver the organization’s EHS &amp; S goals and strategy.&nbsp;</li><li>Setting up strong Safety First culture.&nbsp;</li><li>Establish and develop procedures and teams for driving EHS improvements and managing EHS programs.&nbsp;</li><li>Communicate with all levels in the organization on EHS to engage with, influence and promote EHS culture.&nbsp;&nbsp;</li><li>Follow up internal and external audit to verify EHS performance and continue improvement&nbsp;</li><li>Maintein ISO14001 and our client compliance tools.&nbsp;</li><li>Ensure safety of construction projects in the Thailand Erni site.&nbsp;</li><li>Ensure safety of plant moving, including but not limited to moving IND equipment out and DDN equipment in. As well as its installation and&nbsp;</li><li>commissioning safety&nbsp;</li></ul> Reporting&nbsp; Implement below tasks in order to meet the requirements of reporting.&nbsp; <ul><li>Report related required EHS&amp;S data to site, BU management, BU EHS and Corporate EHS.&nbsp;</li><li>Report related EHS&amp;S data required based on applicable legal regulations and company policies.&nbsp;</li><li>Monitor and report organizational safety performance against our client Safety Tool.&nbsp;</li><li>Evaluate and report environmental performance quarterly using company environmental assessment tools.&nbsp;</li></ul> Sustainability and BCP&nbsp; Focus on GHG, energy,&nbsp;hazardous waste &amp; scope 3 reduction.&nbsp;&nbsp; <ul><li>Track energy reducion data.&nbsp;</li><li>Work with Facility team to identify opportunities of energy reduction.&nbsp;</li><li>Coordinate business contunity plan of DG site.&nbsp;</li><li>Follow BU, Seg and Corp policy and lead scope 3 reduction of the site&nbsp;</li></ul> Requirements: <ul><li>University degree or equivalent level of qualification in safety, health, environmental, chemical, mechanical or related technical discipline&nbsp;</li><li>Thailand government required qualification as company EHS manager is a MUST&nbsp;</li><li>Professional EHS Certification preferred.&nbsp;</li><li>Minimum 8+ years EHS experience required.&nbsp;</li><li>Minimum 5+ years experience in EHS management in manufacturing.&nbsp;</li><li>3+ years construction safety experience is a MUST.&nbsp;</li><li>Knowledge and experenice on scope 3 is preferred.</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>

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>

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

Responsibilities: Warehouse &amp; Materials Management <ul><li>Oversee all warehouse activities including receiving, storage, handling, and internal material movement to ensure compliance with cGMP, DEA, and safety regulations.</li><li>Develop and maintain systems for inventory management, accuracy, and traceability, including raw materials, components, packaging, and finished goods.</li><li>Ensure timely and compliant movement of materials to support production schedules and product release timelines.</li><li>Collaborate with Quality and Compliance teams to maintain cGMP storage practices, support inspections, and ensure readiness.</li></ul> Planning &amp; Supply Coordination <ul><li>Lead the site’s production and materials planning processes to ensure timely availability of materials and resources to meet manufacturing demands.</li><li>Manage and optimize the site’s Master Production Schedule (MPS), material requirement planning (MRP), and capacity planning tools.</li><li>Coordinate with corporate Supply Chain and Procurement functions to align site planning with supplier performance and external manufacturing dependencies.</li></ul> Project Management &amp; Integration <ul><li>Serve as a site-level project manager for cross-functional initiatives including new product introductions (NPIs), facility readiness, equipment onboarding, and continuous improvement projects.</li><li>Develop project timelines, resource allocations, risk assessments, and stakeholder communication plans to ensure successful project execution.</li><li>Support greenfield and expansion activities by coordinating logistics, materials, and equipment staging activities.</li></ul> Systems &amp; Process Development <ul><li>Lead implementation and optimization of ERP and warehouse management systems to enable efficient and compliant operations.</li><li>Develop and implement SOPs, training programs, and KPIs across warehouse and planning functions.</li><li>Identify opportunities for process automation, waste reduction, and continuous improvement in site logistics operations.</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in Supply Chain, Engineering, Business, Operations Management, or related field.</li><li>7+ years of progressive experience in warehouse, planning, or project management roles within pharmaceutical or highly regulated industries.</li><li>Strong understanding of cGMPs, DEA requirements for controlled substances, and sterile manufacturing logistics.</li><li>Proven experience implementing ERP systems (SAP, Oracle, etc.) and managing warehouse or supply chain digital tools.</li><li>PMP certification or formal project management training strongly preferred.</li></ul> Skills/Competencies: <ul><li>Strong organizational, analytical, and problem-solving skills.</li><li>Effective leadership and team-building abilities across cross-functional stakeholders.</li><li>Proficiency in project management tools and planning systems.</li><li>Excellent verbal and written communication with the ability to influence at all levels.</li><li>High sense of ownership, attention to detail, and adaptability in a fast-paced, startup environment.</li><li>Commitment to compliance, quality, and patient-centered operations.</li></ul>

Responsibilities: <ul><li>Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.</li><li>Supervise and manage the incoming and final inspection areas.</li><li>Drive improvement initiatives within incoming, in-process, and final inspection operations.</li><li>Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&amp;Rs.</li><li>Identify and execute containment actions for nonconforming materials found during in-process or final inspections.</li><li>Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.</li><li>Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.</li><li>Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).</li><li>Create and update operations procedures and documentation used within production.</li><li>Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.</li><li>Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.</li><li>Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.</li><li>Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.</li></ul> Requirements: Qualifications/Background: <ul><li>Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).</li><li>Prior experience as a Quality Engineer in a manufacturing environment.</li><li>5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.</li><li>Supervisory or management experience preferred.</li><li>Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.</li><li>Excellent written and verbal communication skills.</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</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>

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15 inspections Jobs found

Quality Technician

Manager - Environmental Health & Safety (EHS)

Quality Associate I

QE Specialist

Associate, Quality Assurance (QMS)

QC Chemist

Manager, Site Logistics & Project Integration

Supervisor – Quality & Reliability Engineering

Manager – ADL GMP

Manufacturing Team Leader

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15 inspections Jobs found

Quality Technician

Manager - Environmental Health & Safety (EHS)

Quality Associate I

QE Specialist

Associate, Quality Assurance (QMS)

QC Chemist

Manager, Site Logistics & Project Integration

Supervisor – Quality & Reliability Engineering

Manager – ADL GMP

Manufacturing Team Leader

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

EMPLOYER

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