Research Associate – II Nitrosamines

Supervisor II Assembly

Reference Standard Coordinator

Regional Employee Relations Manager

Manufacturing Engineer

Project Management Engineer

Supply Chain Analyst

Senior Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Manufacturing Team Leader

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Responsibilities: <ul><li>To Plan and establish production work schedule to meet delivery times and best utilize company production capacity by releasing work orders.</li><li>Scheduling for materials and production in Coordination with staff throughout the company to ensure timely delivery to customers by obtaining agreement for product ship dates.</li><li>To take full responsibility of the shift in terms of management of staff, management of production and quality targets and to ensure the smooth running of the production processes, produced within the shift in line with the company’s quality systems, processes and procedures.</li><li>To demonstrate excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered during the shift in line with the companies Health and Safety policy.</li><li>Confer with other supervisors and managers to coordinate operations and activities within or between departments.</li><li>Monitor, measure, and report on production related process performance/KPI’s, general issues and ensure the team is self-managed (SMT) on problem solving and troubling shooting skills to identify root causes and take fast effective action to resolve the problems in hand.</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Demonstrate customer centric approach and adherence to customer expectations to promote a positive company image.</li><li>Responsible for on-the-job training of directs. Play active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li><li>Set departmental process and link to ISO procedure.</li><li>Stake holder Management</li></ul> Requirements:&nbsp; Professional Experience <ul><li>5 to 7 Years of experience in the same field and industry.</li><li>Bachelor’s degree in mechanical or Electronics Engineering</li><li>Advanced skills with Microsoft Office, especially Excel</li></ul>&nbsp;Leadership Experience: <ul><li>Deep understanding and professional experience of people management.</li><li>Excellent communication and convincing skills</li><li>Self-driven and detail-oriented</li><li>Desire to solve problems with analytical thinking</li><li>Good at people management and execution skills</li><li>Strong organizational skills and a team player</li></ul>&nbsp;Project Experience: <ul><li>Expert in material and production planning.</li><li>Knowledge of SAP</li><li>Quality and Environmental Management System knowledge</li><li>Excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered to during the shift in line with the companys Health and Safety policy</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Play an active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li></ul>&nbsp;Qualifications: <ul><li>Bachelor of Science or above degree and an engineering background.</li><li>Preferably Mechanical, Electrical/Electronics, and Industrial Engineer</li></ul>&nbsp;Other Requirements: <ul><li>3-5+ years’ experience as a practitioner as an Engineer.</li><li>Knowledge in Mechanical, Electrical, and Pneumatic drawings.</li><li>Solid understanding of health and safety regulations and practices.</li><li>Strong decision-making and problem-solving skills.</li><li>Excellent communication and interpersonal skills.</li><li>Computer literate with capability in email, MS Office, and related communication tools.</li><li>Knowledge in various machines from Stamping, Molding, Plating, and Assembly.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Lead and manage employee relations activities within the IMEA region, ensuring timely and fair case resolution in alignment with global ER policies and practices.</li><li>Provide direct ER leadership over the India business in particular, as the largest business in the region.</li><li>Support labor/industrial relations strategy across the region, including union engagement, worker committee processes, and required consultation protocols under local law.</li><li>Serve as the primary escalation point for complex and high-risk ER cases, partnering with Legal and other stakeholders as needed.</li><li>Directly manage ER case intake, investigation, resolution, and closure, ensuring a consistent, professional colleague experience across the region.</li><li>Partner with regional Business-Facing HR teams to deliver hybrid ER support where needed, especially in countries with minimal headcount or unique legal complexity.</li><li>Provide day-to-day direction and mentorship to regional ER Advisors, ensuring professional service delivery, skill development, and workload balance.</li><li>Monitor case trends, emerging risks, and workforce issues, delivering actionable insights and recommendations to regional and global leadership.</li><li>Execute the Employee Relations annual governance cycle within the region, including quarterly campaign delivery, stakeholder reporting, and process audits.</li><li>Ensure full adoption of ER case management protocols in ServiceNow, including accurate logging, escalation, documentation, and timely case closure.</li><li>Deliver coaching and education to site leaders on performance management, conflict resolution, workplace expectations, and policy application.</li><li>Collaborate on global ER projects and initiatives, bringing IMEA-specific insights to shape global practices, policies, and processes.</li><li>Support leaders to foster a fair, consistent, and compliant employee experience aligned with our client People Plan.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Human Resources, Business Administration, or a related field; Master’s degree preferred.</li></ul> Experience: <ul><li>7+ years of experience in employee relations or HR, including regional or global support experience.</li><li>5+ years of employee relations or HR experience in India</li><li>3+ years managing complex employee relations cases required.</li><li>Experience working in a centralized Employee Relations delivery model preferred.</li></ul> Skills:&nbsp; <ul><li>Strong leadership and delegation skills, excellent problem-solving and conflict resolution skills, team leadership experience, and expertise in handling escalated cases and performance improvement processes.</li><li>Proficiency in English and Marathi required; additional languages based on region are a plus (e.g., Arabic, Hindi, French).</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Manage the overall project process, controlling schedule and quality to ensure timely delivery.</li><li>Develop project plans and set milestones during the initial stage.</li><li>Track progress of tasks, hold meetings when necessary, and drive team members to complete tasks efficiently.</li><li>Coordinate with procurement, cost, logistics, production staff, and suppliers to ensure smooth execution of project activities.</li><li>Review project budgets and costs; conduct tooling strategy meetings.</li><li>Identify alternative resources to reduce costs and make directional decisions based on project requirements.</li><li>Assess potential risks and arrange preventive actions to avoid them.</li></ul> Requirements: <ul><li>5–8 years of solid project management experience, especially with APQP and&nbsp;</li><li>PPAP quality knowledge and related project process management.</li><li>Age: under 40 years old.</li><li>Education: Bachelor’s degree (full-time) in engineering, preferably mechanical engineering or related fields.</li><li>Degrees in business administration, language, or arts will not be considered.</li><li>Work location: Building G1, No. 88 Dongchang Road, Suzhou Industrial Park (Suzhou 2.5 Industrial Park).</li></ul>

Responsibilities: <ul><li>Develop and track Delivery performance metrics (STR/STS, PDR/PDS, Red Alert)</li><li>Central governance of DC Planning Parameters, maintaining set business rules from top management using data analytics tool and dashboard</li><li>Review unhealthy stock levels, conduct root cause analysis and back to normal actions</li><li>Coordinate global stock rebalancing activities</li><li>Drives Monthly Global Scrap disposal for distribution centers</li><li>Implement projects for process improvement for UHS inventory performance</li><li>Analyze Stocking Policy and Safety Stocks Optimization tool prescription and recommend based on criteria for global Distribution Centers</li><li>Establish business rules and analyze SS tool prescription and recommend based on criteria for global Distribution Centers</li><li>Present findings and recommendations of Stocking Policy and Safety Stocks to management</li><li>Lead development of data analytics tool and dashboard to govern and monitor RCA and Action Items process with the help of Data Insights and Analytics team</li><li>Collaboration with cross-functional team (DC planning, Source Plants, CCP, NPI team, Supply planning &amp; Master Data team) on strategies based off root cause analysis and action items methodology to drive delivery performance improvements</li><li>Centralization of Root Cause Analysis and Action Items Process for Delivery Performance</li><li>Drive strategic actions to achieve faster and more reliable performance to enhance customer satisfaction</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s degree in supply chain, Operation Management, Mathematics, Statistics, or related field</li><li>5+ years working experience in Supply Chain</li><li>Experience using SAP S/4 Hana, IBP, or equivalent planning tools a must</li><li>Manage PNs/SKUs with annual revenue of $1.4B+</li><li>Proficient in MS Office</li><li>Strong Analytical &amp; Continuous improvements Skills as well as good understanding of data analytics capabilities</li><li>Strong interpersonal skills, ability to work with various levels of the organization.</li><li>Excellent oral and written communication skills, both in -1-to +1 situations and group settings</li></ul>

Responsibilities: <ul><li>Lead and support process improvement projects to optimize manufacturing efficiency, reduce waste, and improve quality</li><li>Develop, validate, and implement manufacturing processes and tooling for new and existing products</li><li>Collaborate with product development, quality, and production teams on new product introduction and design for manufacturability</li><li>Identify root causes of production issues and implement corrective and preventive actions</li><li>Lead Lean Six Sigma and 5S initiatives across the production floor</li><li>Support capacity planning and equipment layout optimization</li><li>Develop and maintain process documentation, work instructions, and standard operating procedures</li><li>Ensure compliance with safety standards, quality systems, and regulatory requirements</li><li>Mentor junior engineers and provide technical guidance to the operations team</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Manufacturing Engineering, or a related field</li><li>Minimum 5 years of experience in a manufacturing or industrial engineering role, preferably in a high-mix, low-volume environment</li><li>Strong knowledge of Lean Manufacturing, Six Sigma, and process optimization techniques</li><li>Experience with manufacturing tools such as PFMEA, control plans, SPC, and root cause analysis</li><li>Proficient in CAD software and Microsoft Office applications</li><li>Excellent analytical, problem-solving, and communication skills</li><li>Ability to lead cross-functional teams and manage multiple projects</li><li>Experience in the electronics or connectivity components industry is an advantage</li></ul>

Responsibilities: <ul><li>Perform evaluations and/or analyze unique problems that are new to equipment.</li><li>Perform predictive maintenance by analyzing routine failures and determining adjustments and repairs that need to be made.</li><li>Perform training as needed to Lower level Maintenance Techs on troubleshooting and repair techniques utilized with equipment</li><li>Perform specified preventative maintenance on production equipment to prevent equipment downtime.</li><li>Monitor equipment operations to ensure proper usage.</li><li>Construct and/or assemble new equipment</li><li>Troubleshoot equipment failures and repair as needed</li><li>Perform specified preventative maintenance on production equipment to prevent equipment down-time</li><li>Perform Lock Out / Tag Out requirements.</li><li>Work from blueprints, manuals, sketches and verbal instructions.</li><li>Help repairing on hydraulic, pneumatic and electromechanical systems.</li><li>Perform other duties as assigned or necessary to meet business conditions or changes.</li><li>Adheres to quality and safety systems or maintenance of quality and safety standards.</li></ul> Requirements: <ul><li>High school diploma or equivalent</li><li>5+ years experience in injection molding maintenance or extrusion, or mechanical, hydraulic, pneumatic and electrical repair</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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71 safety administration Jobs found

Research Associate – II Nitrosamines

Supervisor II Assembly

Reference Standard Coordinator

Regional Employee Relations Manager

Manufacturing Engineer

Project Management Engineer

Supply Chain Analyst

Senior Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Manufacturing Team Leader

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Skills

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71 safety administration Jobs found

Research Associate – II Nitrosamines

Supervisor II Assembly

Reference Standard Coordinator

Regional Employee Relations Manager

Manufacturing Engineer

Project Management Engineer

Supply Chain Analyst

Senior Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Manufacturing Team Leader

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

EMPLOYER

TALENT

COMPANY

Contact Us

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