Distribution Resource Planner

AVP AI Solutions Management

Business Development Manager Projects

Tax Lead - SSEA

Tax Supervisor

QC Lab Sample Coordinator

Corporate Legal Counsel

Quality Engineer

Reference Standard Coordinator

Role Description:&nbsp;&nbsp; <ul><li>The Distribution Resource Planner works alongside the Regional Distribution Planner in guaranteeing uninterrupted supply to customers and/or our client sites by balancing supply, demand and inventory.&nbsp;</li><li>The role serves in active partnership on all supply related questions from business partners (BO Management, Demand Manager, Product Quality, Sales, Logistics, Customers Service, Manufacturing and Supply Planner).&nbsp;</li><li>This person will work closely with Global planning and functionally reports to the Supply Chain Manager.&nbsp;</li></ul> Responsibilities:&nbsp; <ul><li>Inventory: Responsible for administration around inventory movements, manage inventory levels and replenishment orders,you manage aged &amp; blocked inventories, relabeling.&nbsp;</li><li>Furthermore, responsible for monthly reconciliations of inventory levels stored at 3rd party warehouses and consignment.&nbsp;&nbsp;</li></ul> <ul><li>Planning: Monitor the 6-month rolling supply plan for imported products as assigned aligned with the regional planner,understand and execute the key analytics in line with the supply processes to ensure optimal demand &amp; supply balance.&nbsp;</li><li>This includes for example coordination on the drumming schedule and vessel arrangements.&nbsp;&nbsp;</li></ul> <ul><li>Projects &amp; Coordination: Initiate improvement opportunities (processes, tools and knowledge) and support implementation of these pro-actively, including optimization of shipment modes, loads and packaging based on costs and inventory.&nbsp;</li></ul>&nbsp;<ul><li>Reporting: Assume responsibility for effective and timely Analysis and Reporting, analyze demand data and measure forecast accuracy, support in the evaluation and maintenance of Safety Stock and Target Inventory numbers for the region and ensures full compliance with Corporate Standard Operating Procedures and all Sarbanes Oxley required processes&nbsp;</li></ul> <ul><li>Safety - Comply with our client safety and wellness musts, complete required HSES trainings through TEDS.&nbsp;Actively engage and promote activities that will enhance safety culture&nbsp;&nbsp;</li></ul> <ul><li>Short Term Planning - Develop and maintain the 6-12 month rolling supply plan for assigned product lines and be an active partner on all supply questions for business partners (BU Management, Demand Managers, Sales, Logistics, Customer Service and Supply Planners)&nbsp;&nbsp;</li></ul> <ul><li>Long Term Planning - Actively supports the Supply Manager in developing the 24 month supply plan for assigned product lines.&nbsp;&nbsp;</li></ul> <ul><li>Demand Verification - Analyze (6 month) demand data, measure forecast accuracy, take appropriate actions, engage with commercial team on forecast changes and document/report out on those&nbsp;&nbsp;</li></ul> <ul><li>Analytics - Understand and execute the key analytics in line with the supply processes to achieve optimal demand &amp; supply balance (re-ordering strategy and execution, reacting to changes in demand)&nbsp;&nbsp;</li></ul> <ul><li>OPEX - Participate in regional (OpEx) meetings that are being held for the business planning for&nbsp;Metrics - Develop, maintain and review inventory measures and take appropriate actions (a.o. safety stock review, dead stock review, 60-100 day file, EEOA, DQO). Review, understand, and drive improvement in HOC metrics (Metric Pack)&nbsp;&nbsp;</li></ul> <ul><li>Master Data - Master data analysis and maintenance, reviewing the settings against ever changing environment and achieve right master data settings to enable best planning results&nbsp;&nbsp;</li></ul> <ul><li>Knowledge - Actively seeks to increase product and market knowledge, Understand business and product strategies for the product range covered&nbsp;&nbsp;</li></ul> <ul><li>Reconciliations - Responsible for monthly reconciliations of inventory levels stored at 3rd party warehouses and ensuring appropriate approvals for adjustments&nbsp;&nbsp;</li></ul> Requirements: Basic Qualifications:&nbsp; <ul><li>Bachelor or Master degree in Logistics, Supply Chain or Industrial Engineering or related business fields is required&nbsp;</li><li>APICS CPIM or comparable certification is a strong pre, demonstrated experience with planning &amp; inventories&nbsp;&nbsp;</li><li>Minimum of 3 years of Planning or Supply Chain experience in an International environment&nbsp;</li><li>Good analytical skills&nbsp;</li><li>Advanced Excel skills&nbsp;</li><li>Fluent in English is required, both verbal and written.</li><li>Additional languages are a plus Preferred Qualifications:&nbsp;&nbsp;</li><li>Experience with SAP / ERP system is a plus.&nbsp;&nbsp;</li><li>Work structured and methodologically in a constant changing environment&nbsp;</li><li>Self-starter, results orientated and independent thinker – always looking for improvement opportunities&nbsp;</li><li>Ability to assemble info to make a big picture, while also able to dive into the underlying details&nbsp;</li><li>Customer focused, pro-active&nbsp;</li><li>Adhere to health, safety and environmental policies and procedures to ensure the safety and wellbeing of self, other staff and visitors</li></ul>

Responsibilities: <ul><li>Support the AI use-case intake process, gather requirements, and rapidly assess strategic fit, value, complexity, and feasibility.</li><li>Maintain an AI use-case/solution inventory; identify duplication and promote reuse of existing platforms and components.</li><li>Evaluate alignment to the company’s AI strategy, enterprise architecture, data strategy, and target operating model.</li><li>Help establish guidelines for build/buy/hybrid and create recommendation artifacts for leadership and governance bodies.</li><li>Assess candidate architectures across cloud services, data platforms, model choices (LLMs, classical ML, CV, NLP), and integration patterns.</li><li>Compare third-party SaaS/managed services with in-house custom builds and hybrids; estimate TCO, scalability, maintainability, and time-to-value.</li><li>Support vendor evaluations and small proof-of-concept efforts, reviewing items like security practices, data handling, SLAs, integration needs, and roadmap alignment.</li><li>Partner with Procurement/Vendor Management on contracting, licensing, data processing, and exit strategies.</li><li>Partner with Engineering, Data Science, and DevOps/MLOps to scope pilots and define success metrics and guardrails.</li><li>Ensure handoffs include documentation, controls, and operational readiness</li><li>Develop playbooks, patterns, and templates to support AI solution reviews, and help enable business and tech teams through training sessions and office hours..</li><li>Track portfolio outcomes (benefits, risk findings, reuse rate) and continuously improve intake and evaluation processes.</li></ul> Requirements: <ul><li>Software engineering and cloud architecture knowledge across AWS/Azure; APIs; event/microservices; observability.</li><li>Good understanding of AI/ML and LLM stacks (vector databases, embeddings, RAG, prompt engineering, guardrails).</li><li>Understanding of privacy/security controls in financial services (data classification, encryption, DLP, IAM, segmentation) and third-party risk.</li><li>Proven ability to translate business objectives into technical evaluation criteria and clear decisions.</li><li>Excellent written and verbal communication for executive-level summaries and deep-dive technical reviews.</li><li>Critical thinker with structured problem-solving and sound judgment</li></ul>

Role Description:&nbsp; <ul><li>The Area Sales &amp; Business Development Manager Congo will be responsible for managing sales operations within a specific geographical region, focusing on building relationships with distributors, retailers, and users to achieve sales targets and grow business within the Congolese market.</li></ul> Responsibilities: Sales: <ul><li>Responsible for the delivery of project sales, through applicators, contractors and developers.</li><li>Responsible for tracking performance against key project pipeline, review progress, manage exceptions</li><li>Commercial understanding of the business to manage receivables as per laid out norms</li></ul> Business Development: <ul><li>Responsible to specify, approve and execute both commercial &amp; residential projects.</li><li>Ability to conduct seminars, webinars, and other engagements with the influencers</li><li>Share key insights and competitor initiatives to improve our strategy and execution plans</li></ul> Team Management: <ul><li>Planning, reviewing, and enhancing the performance of each of the team member.</li><li>Strengthening the capability of team and drive motivation, engagement to deliver high performance.</li></ul> Requirements: <ul><li>Academic Background: Civil Engineer.</li><li>Experience required: Candidate should have min 5-6 years in the construction chemicals segment.&nbsp;</li></ul>

Looking for Thailand Tax expereince in Indonesia. Responsibilities: <ul><li>In charge of tax compliance execution for Thailand, Singapore, India and other countries or cities.&nbsp;</li><li>The scope includes but not limited to designing and timely reviewing tax reporting, tax forecast, and budget process, and etc.</li><li>Work with cross functions (i.e. FP&amp;A, Global tax) to set up tax forecast and budget, and monitor and adjust (if applicable) it on monthly basis.</li><li>Be responsible for tax-related data collection and analysis (i.e. Tax Burden Ration on both P&amp;L and cash basis, Margin, and Transfer Price, etc.) and outstanding problems / questions resolution in order to 1) increase tax efficiency; 2) mitigate tax risk; and 3) accurate tax forecast or budget.&nbsp;</li><li>Independently manage internal tax health check, and provide proposal &amp;advice to reduce compliance risk.</li><li>Lead transfer price strategy setting up for both domestic and cross-border transaction for all countries and cities in SSEA.&nbsp;</li><li>Design detail transfer price plan (I.e. mark-up rate, sales price, transaction flow, etc.) for each affiliates and each transfection types, and ensure the success of implementation.&nbsp;</li><li>Prepare transfer price documentations to support the strategy and plan.&nbsp;</li><li>As internal consultant to provide tax guidance to related functions (e.g. supply chain finance, GL).&nbsp;</li><li>Monitor the tax status and position on monthly basis, and handle challenges, questions and tax audits (if any) from each level of tax authorities.&nbsp;</li><li>Establish or maintain the good relationship with Finance Bureau, Tax Bureau, and other government authorities.&nbsp;</li><li>Manage and coordinate with external consultants.&nbsp;</li><li>Support AEM tax lead in coordination with global tax team to keep consistent tax strategy between local and global.&nbsp;</li><li>Support global tax team for tax return or provision preparation for other jurisdictions from compliance perspective.</li><li>Lead complicated applications such as tax exemption / reduction / deferral application, cross-border double tax treaty application, tax liquidation application, tax audit defense, etc and make achievements.&nbsp;</li><li>Proactively seek benefit such as government incentives for group from not only tax perspective.&nbsp;</li><li>Propose suggestions or ideas for any improvement or projects, and lead the implementation to make it happen.&nbsp;</li><li>Work together with AEM tax lead to plan annual tax projects.&nbsp;</li><li>Lead feasibility study by leveraging consulting reassure.&nbsp;</li><li>Land the execution from end to end</li></ul> Requirements: <ul><li>Smart and honest.&nbsp;</li><li>Dare to work under pressure.&nbsp;</li><li>Analytical thinking and passionate for results, with abundant passion/curiosity for learning.</li><li>Strong drive &amp; high energy, hands on and pragmatic, independent and proactive.&nbsp;</li><li>At least 6 years tax related job experience required including strong Asia exposure (i.e. Singapore, Thailand, etc.) with a comprehensive understanding of taxation, regulations and accounting.&nbsp;</li><li>Multinational company or consultant firm experiences is preferred.&nbsp;</li><li>More than 2 years experience in leader level.&nbsp;</li><li>Experience in tax project management and tax process design is a must.&nbsp;</li><li>Excellent knowledge and understanding of corporate governance practices and procedures.</li><li>Fluent language skills (both written and verbal) in English.</li><li>High ethical standards and result-focused, able to work in fast-paced, dynamic environment.</li><li>Ability to identify opportunities for improvement and implement creative solutions.</li><li>A team player, effective communicator, strong interpersonal skills and ownership behavior.</li></ul>

Responsibilities: <ul><li>In charge of tax compliance execution for Thailand, Singapore, India and other countries or cities.&nbsp;</li><li>The scope includes but not limited to designing and timely reviewing tax reporting, tax forecast, and budget process, and etc.</li><li>Work with cross functions (i.e. FP&amp;A, Global tax) to set up tax forecast and budget, and monitor and adjust (if applicable) it on monthly basis.</li><li>Be responsible for tax-related data collection and analysis (i.e. Tax Burden Ration on both P&amp;L and cash basis, Margin, and Transfer Price, etc.) and outstanding problems / questions resolution in order to 1) increase tax efficiency; 2) mitigate tax risk; and 3) accurate tax forecast or budget.&nbsp;</li><li>Independently manage internal tax health check, and provide proposal &amp;advice to reduce compliance risk.</li><li>Lead transfer price strategy setting up for both domestic and cross-border transaction for all countries and cities in SSEA.&nbsp;</li><li>Design detail transfer price plan (I.e. mark-up rate, sales price, transaction flow, etc.) for each affiliates and each transfection types, and ensure the success of implementation.&nbsp;</li><li>Prepare transfer price documentations to support the strategy and plan.&nbsp;</li><li>As internal consultant to provide tax guidance to related functions (e.g. supply chain finance, GL).&nbsp;</li><li>Monitor the tax status and position on monthly basis, and handle challenges, questions and tax audits (if any) from each level of tax authorities.&nbsp;</li><li>Establish or maintain the good relationship with Finance Bureau, Tax Bureau, and other government authorities.&nbsp;</li><li>Manage and coordinate with external consultants.&nbsp;</li><li>Support AEM tax lead in coordination with global tax team to keep consistent tax strategy between local and global.&nbsp;</li><li>Support global tax team for tax return or provision preparation for other jurisdictions from compliance perspective.</li><li>Lead complicated applications such as tax exemption / reduction / deferral application, cross-border double tax treaty application, tax liquidation application, tax audit defense, etc.&nbsp;</li><li>and make achievements.&nbsp;</li><li>Proactively seek benefit such as government incentives for group from not only tax perspective.&nbsp;</li><li>Propose suggestions or ideas for any improvement or projects, and lead the implementation to make it happen.&nbsp;</li><li>Work together with AEM tax lead to plan annual tax projects. Lead feasibility study by leveraging consulting reassure. Land the execution from end to end</li></ul> Requirements: <ul><li>Smart and honest. Dare to work under pressure. </li><li>Analytical thinking and passionate for results, with abundant passion/curiosity for learning.</li><li>Strong drive &amp; high energy, hands on and pragmatic, independent and proactive.&nbsp;</li><li>At least 6 years tax related job experience required including strong Asia exposure (i.e. Singapore, Thailand, etc.) with a comprehensive understanding of taxation, regulations and accounting. Multinational company or consultant firm experiences is preferred.&nbsp;</li><li>More than 2 years experience in leader level. </li><li>Experience in tax project management and tax process design is a must.&nbsp;</li><li>Excellent knowledge and understanding of corporate governance practices and procedures.</li><li>Fluent language skills (both written and verbal) in English.</li><li>High ethical standards and result-focused, able to work in fast-paced, dynamic environment.</li><li>Ability to identify opportunities for improvement and implement creative solutions.</li><li>A team player, effective communicator, strong interpersonal skills and ownership behavior.</li></ul>

Responsibilities: <ul><li>Handle (including prepare/review) all direct / indirect tax compliance process to ensure the timely filing of the Indian tax returns.</li><li>Handle the tax audits, assessments, appeals in India, including attending hearings.</li><li>Preparing all tax communications and correspondences to the tax offices or reviewing those prepared by the external adviser.</li><li>Implement the company global transfer pricing strategy locally and work with US Corporate on transfer pricing documentation.</li><li>Address any direct/indirect tax issues arising from operational / tax law changes and recommend solutions to the management.</li><li>Liaise with the external tax advisors for practical advices on the tax implications of non-routine transactions, such as cross-border transactions, reorganizations, mergers and acquisitions etc., including negotiating with the local tax authorities and obtaining advance ruling, where applicable.</li><li>Handle the tax accounting work, including the quarterly ASC 450 and 740 assessment for the uncertain tax positions and memo preparation.</li><li>Attend to any tax related queries raised by the external auditors.</li><li>Estimation and payment of local corporate tax and withholding taxes.</li><li>To act as the contact point for the Indian tax related matters.</li><li>Involve any other ad-hoc projects, including active participation in cross functional team discussions /projects concerning tax directly/ indirectly and contributing to the optimal tax outcome based on viable business solutions.</li><li>Conduct health-checks and reviews on internal controls for the tax processes from time to time.</li><li>Conduct trainings on tax topics for cross functional teams from time to time</li><li>Independently handle GST audits and assessments</li></ul> Requirements: <ul><li>Chartered Accountant with competencies in indirect taxes (especially GST), Indian corporate income and transfer pricing</li><li>At least 2-5 years relevant working experience, preferably in a Big 4 CPA firm or niche consultancy firms in tax advisory, assessment and litigation</li><li>Tax compliance and Tax return preparation skills</li><li>Excellent analytical and problem solving skills</li><li>Job specific competence: has accounting knowledge and has capability to research on any topic</li><li>Should be a team player, self-motivated, result driven with ability to communicate clearly and concisely with personnel from different levels and both within and outside the organization</li><li>Capable/proven decision maker, effectively bilingual (spoken and written)</li><li>Strong command of the English Language, both written and verbal communication</li><li>Good working knowledge in MS office</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs 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 laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</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 sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, 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&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and 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&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia 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.</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 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 computer savvy.</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.</li><li>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>

Role Description: <ul><li>We are seeking a qualified and experienced Corporate Legal Counsel to join our Legal team in Egypt.</li><li>This middle management role supports corporate legal operations across Egypt and support MENAT region, with a focus on contract management, governance, regulatory compliance, and internal advisory.</li><li>The successful candidate will report directly to the Head of Legal and act as a legal business partner to internal stakeholders.</li></ul> Responsibilities: Corporate and Regional Support <ul><li>Assist in reviewing corporate processes and documentation within Egypt.</li><li>Support legal coordination and compliance efforts across the MENAT region.</li><li>Maintain and update corporate records and filings in accordance with internal and regulatory requirements.</li><li>Support corporate secretarial functions across the region and ensure timely documentation.</li></ul> Contract Management and Documentation <ul><li>Draft, review, and revise legal documents including but not limited to contracts, NDAs, service agreements, B2B/B2C agreements, and purchase orders.</li><li>Collaborate with internal teams and external counsel to ensure contractual terms meet legal and business objectives.</li><li>Maintain organized records of executed agreements and develop standardized templates.</li></ul> Governance and Compliance <ul><li>Assist in implementing internal governance policies and monitor compliance.</li><li>Conduct legal research and support risk assessments related to business decisions.</li><li>Identify potential legal risks and escalate issues to the Head of Legal with recommended solutions.</li></ul> Legal Advisory and Communication <ul><li>Provide clear explanations of legal terms and obligations to internal stakeholders.</li><li>Provide legal opinion and consultations to internal stakeholders.</li><li>Act as a liaison between the legal department and other business units.</li><li>Prepare legal summaries and reports for senior legal review.</li></ul> Regulatory and Governmental Affairs <ul><li>Support corporate matters including GAFI documentation and authentication processes.</li><li>Liaise with governmental authorities regarding licensing and regulatory compliance.</li><li>Ensure adherence to company HSE policies and contribute to legal compliance in risk assessments.</li><li>Handle external law firms and corporate secretariate work and have the ability to draft bilingual OGMs, EGMs and BoDs.</li></ul> Requirements: <ul><li>Bachelor of Law (LL.B.) or Juris Doctor (J.D.) with a minimum grade of “Good”.</li><li>Master of Laws (LL.M) or equivalent postgraduate qualification is a plus.</li><li>4 – 7 years of experience in corporate law within a reputable law firm or multinational organization.</li><li>Admitted to the Egyptian Bar Association.</li><li>Fluent in English and Arabic (written and spoken).</li><li>Strong knowledge of contract law, corporate governance, licensing, and regulatory frameworks.</li><li>Familiarity with GAFI procedures and governmental dealings.</li><li>Litigation experience is a plus.</li></ul> Skills and Competencies <ul><li>Legal research, drafting, and negotiation.</li><li>Strong analytical and problem-solving skills.</li><li>Excellent communication and presentation abilities.</li><li>Ability to manage multiple tasks and meet deadlines.</li><li>High attention to detail and sound judgment.</li><li>Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification 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>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</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>Minimum of 7-10 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 </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</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>&nbsp;Strong knowledge of validation principles and qualification documentation </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>

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>

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Distribution Resource Planner

AVP AI Solutions Management

Business Development Manager Projects

Tax Lead - SSEA

Tax Lead - SSEA

Tax Supervisor

QC Lab Sample Coordinator

Corporate Legal Counsel

Quality Engineer

Reference Standard Coordinator

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18 reviewing Jobs found

Distribution Resource Planner

AVP AI Solutions Management

Business Development Manager Projects

Tax Lead - SSEA

Tax Lead - SSEA

Tax Supervisor

QC Lab Sample Coordinator

Corporate Legal Counsel

Quality Engineer

Reference Standard Coordinator

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