Research Associate – II Nitrosamines

Supervisor II Assembly

Reference Standard Coordinator

Finance Manager

Accountant

Manufacturing Engineer

Manufacturing Team Leader

Demand Analyst 

Head of Finance/Finance Director

Accounts Payable Manager

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>

Requirements Financial Management &amp; Reporting: <ul><li class="ql-align-justify">Oversee all accounting operations of the site including Accounts Payable, Accounts Receivable, General Ledger, Cost Accounting, and Inventory Accounting.</li><li class="ql-align-justify">Ensure timely and accurate preparation of financial statements in accordance with local Polish GAAP and Group IFRS standards.</li><li class="ql-align-justify">Manage the period-end closing process effectively and efficiently.</li><li class="ql-align-justify">Prepare comprehensive financial reports, including monthly variance analysis, for local management and global stakeholders.</li><li class="ql-align-justify">Responsible for cash flow management, forecasting, and optimization at the site level, coordinating closely with the Global Treasury Director.</li><li class="ql-align-justify">Lead the annual budgeting and forecasting processes for the Polish site, in conjunction with the Global FP&amp;A Director.</li><li class="ql-align-justify">Monitor and analyze key financial performance indicators (KPIs) and provide actionable insights to improve profitability and efficiency.</li><li class="ql-align-justify">Assessments of CapEx proposals by site.</li></ul> Business Partnering &amp; Strategy: <ul><li class="ql-align-justify">Act as a key strategic partner to the General Manager, Poland, providing financial guidance and support for operational decisions.</li><li class="ql-align-justify">Participate actively in local management team meetings, contributing to overall business strategy and operational improvements.</li><li class="ql-align-justify">Identify opportunities for cost reduction, revenue enhancement, and process optimization.</li><li class="ql-align-justify">Conduct financial analysis for new projects, investments, and business initiatives.</li><li class="ql-align-justify">Collaborate with sales, operations, and other departments to ensure financial targets are met.</li></ul> Controllership &amp; Compliance: <ul><li class="ql-align-justify">Ensure robust internal controls are in place and adhered to, safeguarding company assets.</li><li class="ql-align-justify">Manage statutory audits and ensure compliance with all Polish financial regulations and tax laws (with external support for complex tax matters).</li><li class="ql-align-justify">Responsible for timely and accurate submission of all local tax declarations (VAT, CIT, etc.), coordinating with external tax advisors as needed.</li><li class="ql-align-justify">Oversee compliance with global financial policies and procedures.</li><li class="ql-align-justify">Manage relationships with external auditors, banks (for local operational needs), and other financial service providers.</li></ul> Team Leadership &amp; Development: <ul><li class="ql-align-justify">Lead a team of 4 Accountants and 2 Controllers, fostering a culture of continuous improvement and high performance.</li><li class="ql-align-justify">Set clear objectives, provide regular feedback, and conduct performance reviews for the finance team.</li><li class="ql-align-justify">Foster strong collaboration within the finance team and with other departments.</li></ul> Global Collaboration: <ul><li class="ql-align-justify">Work closely with the Global FP&amp;A Director on budgeting, forecasting, and performance analysis.</li><li class="ql-align-justify">Collaborate with the Global Treasury Director on cash management strategies and funding requirements.</li><li class="ql-align-justify">Provide timely and accurate financial information to the Global CFO and other global finance leaders.</li><li class="ql-align-justify">Ensure alignment of local financial practices with global standards and systems.</li></ul> Requirements: <ul><li>Education: Bachelors degree in Finance, Accounting, Economics, or a related field. Masters degree is preferred.</li></ul> Experience: <ul><li>Minimum of 8-10 years of progressive experience in finance roles, with at least 3-5 years in manufacturing environment.</li><li>Proven experience working in an international or multinational company is essential.</li><li>Strong understanding of Polish GAAP and IFRS.</li><li>Demonstrated experience with ERP systems (e.g., SAP, Oracle).</li><li>Experience managing and developing a finance team.</li></ul> Skills: <ul><li>Fluent in Polish and English (both written and spoken).</li><li>Excellent analytical and problem-solving skills, with a strong attention to detail.</li><li>Strong leadership and interpersonal skills, with the ability to influence and collaborate effectively across all levels of the organization.</li><li>Proven ability to work independently and manage multiple priorities in a fast-paced environment.</li><li>Strategic thinking with a hands-on approach.</li><li>Proficient in Microsoft Office Suite, especially Excel.</li></ul>

Responsibilities: <ul><li>Issue and mail tax invoices to customers, entry tax invoice information in the customers’ system if needed.</li><li>Enter entries in the accounting system.</li><li>Response for organizing and checking the employee reimbursement and payment documents.</li><li>Reconciling the related control accounts.&nbsp;</li><li>Support finishing monthly and yearly closing.</li><li>Support annual/internal audit.</li><li>Assist in organizing financial documents.</li><li>Handle other work or project assigned by manager.</li><li>Maintain and update internal records and reports.</li><li>Provide administrative support to ensure smooth daily operations.</li></ul> Requirement: <ul><li>Experience: 3+ yrs</li><li>Familiarity with the specific tax regulations in mainland China</li><li>Strong written and spoken English</li><li>Detail-oriented, self-motivated, and able to meet deadlines under pressure</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>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>Facilitate the global Sales and Operating Planning (S&amp;OP) process by conducting a reliable and efficient monthly demand review for the designated territory and product lines.</li><li>Collaborate with the sales team and product management to create an accurate and comprehensive consensus forecast, which includes organizing formal monthly demand review meetings.</li><li>Partner with the sales organization, global product management team, and Finance team in the quarterly commit sales forecasting process and annual sales budgeting process.</li><li>Deliver monthly product mix forecasts to the operations and supply chain teams, highlighting potential opportunities for growth as well as any associated risks</li><li>Track the demand plan against actual results on a monthly basis, assessing forecast accuracy and providing detailed insights to operations. Hold key contributors - such as product management, sales, and operations - accountable for their performance.</li><li>Drive continuous improvement on processes and methodologies for collecting information and predicting demand.</li><li>Consistent attendance, understanding of, and compliance with company policies, rules, and regulations.</li></ul> Requirements: <ul><li>Bachelor’s degree, or its equivalent, in a related field, such as finance, marketing, business administration, supply chain, operations management, or industrial engineering required. APICS or other certification is preferred.&nbsp;</li><li>Excellent analytical and advanced computer skills (such as Excel), with the ability to mine data and derive critical and salient information from diverse inputs.&nbsp;</li><li>Experience with analytical systems and tools (IBP/SAP/Data Warehouse, etc.) preferred.</li><li>Quick learner, capable of adapting to new systems and developing and continuously improving processes.</li><li>Excellent communication skills (clear, concise oral and written presentations), interpersonal skills, effective negotiation and influencing skills, capable of being unbiased and fair in achieving compromise solutions and consensus positions.&nbsp;</li><li>3-5 years experience in S&amp;OP, demand planning, supply chain, material planning, or capacity planning.&nbsp;</li><li>Fluent in Putonghua and English.</li><li>Project management and problem-solving skills.</li><li>Ability to work independently in an international environment and willing to travel periodically (short periods) including abroad if needed.</li></ul>

Responsibilities : Strategic Leadership: <ul><li>Develop and implement financial strategies aligned with overall business objectives.</li><li>Provide financial insights and recommendations to support decision-making.</li><li>Partner with senior leadership to drive business performance.</li></ul> Financial Management: <ul><li>Lead budgeting, forecasting, and long-term financial planning.</li><li>Monitor financial performance against targets and highlight variances.</li><li>Oversee cash flow management, working capital, and capital expenditure.</li></ul> Accounting &amp; Compliance: <ul><li>Ensure accuracy, integrity, and timeliness of financial reporting.</li><li>Oversee compliance with statutory, tax, and regulatory requirements.</li><li>Manage audits and liaise with external auditors, tax advisors, and regulatory bodies.</li></ul> Risk Management &amp; Controls:<ul><li>Establish robust internal controls and risk management frameworks.</li><li>Safeguard company assets and ensure proper governance practices.</li></ul> Team Leadership: <ul><li>Lead, mentor, and develop the finance team.</li><li>Foster a culture of accountability, efficiency, and continuous improvement.</li></ul> Requirements: <ul><li>Bachelor’s degree in Finance, Accounting, or related field (Master’s degree / MBA preferred).</li><li>Professional qualifications such as CPA, CA, ACCA, or CFA.</li><li>10+ years of progressive finance leadership experience, preferably from construction industry.</li><li>Strong knowledge of local financial regulations, tax laws, and corporate governance.</li><li>Proven experience in strategic planning, financial analysis, and business partnering.</li><li>Fluent in local language and English</li></ul>

Responsibilities: <ul><li>Lead, mentor, and develop the S2P Team Lead Associate and Associates.</li><li>Conduct regular performance reviews, coaching, and feedback sessions.</li><li>Monitor the invoice-to-pay cycle to guarantee timely and error-free payment processing.</li><li>Collaborate with regional Finance Controllers/Directors to identify and resolve issues.</li><li>Develop, maintain, and track operational metrics, scorecards, and KPIs aligned with SLAs.</li><li>Drive process automation and digital tool adoption to improve efficiency.</li><li>Identify and implement continuous improvement initiatives across S2P operations.</li><li>Build strong collaborative relationships with Global Process Owners and stakeholders.</li><li>Ensure compliance with tax regulations, internal controls, and corporate policies.</li><li>Support standardization and optimization of processes across supported entities.</li><li>Manage month-end close activities and A/P reporting.</li><li>Promote a culture of continuous learning, accountability, and high performance.</li></ul> Competencies &amp; Skills <ul><li>Strong understanding of end-to-end Source-to-Pay processes and enabling technologies.</li><li>Conflict resolution, team development, and motivation skills.</li><li>Strong communication and stakeholder management skills across internal and external partners.</li><li>Ability to influence and negotiate at various organizational levels.</li><li>Strong analytical and problem-solving capabilities.</li><li>Experience in leading organizational change and transformation initiatives.</li><li>Proficiency in English (and local language as applicable).</li><li>Strong skills in performance management, audit readiness, and risk mitigation.</li><li>Comfort with ambiguity, adaptability, and driving change in dynamic environments.</li><li>Strong collaboration mindset with focus on value creation and efficiency.</li><li>Proficiency in SAP; knowledge of ServiceNow (SNOW) is a plus.</li></ul>&nbsp;Requirements: Experience &amp; Educational Requirements <ul><li>5–7 years of relevant experience in a Financial Solutions Center supporting multiple countries/business units (preferably in industrial/manufacturing industries).</li><li>3–5 years of leadership/managerial experience, ideally within shared services or global business services.</li><li>Proven track record in achieving KPIs, SLAs, and customer satisfaction goals.</li><li>Strong accounting background with deep A/P and compliance knowledge.</li><li>Graduate degree in Finance, Accounting, or equivalent experience.</li><li>Experience in managing culturally diverse, global teams.</li></ul>

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57 regulations Jobs found

Research Associate – II Nitrosamines

Supervisor II Assembly

Reference Standard Coordinator

Finance Manager

Accountant

Manufacturing Engineer

Manufacturing Team Leader

Demand Analyst

Head of Finance/Finance Director

Accounts Payable Manager

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Skills

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57 regulations Jobs found

Research Associate – II Nitrosamines

Supervisor II Assembly

Reference Standard Coordinator

Finance Manager

Accountant

Manufacturing Engineer

Manufacturing Team Leader

Demand Analyst

Head of Finance/Finance Director

Accounts Payable Manager

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

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COMPANY

Contact Us

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