Job Details:

Lead Analyst Full details of the job. Vacancy Name\tLead Analyst\nVacancy No\tVN658\nDepartment\tQuality\nLocation\tZeeland\nEmployment Type\tFull-Time\nCompany Overview\tAurorium is the materials innovation partner that helps global manufacturers harness the power of possibility making the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions. Key industries served include healthcare, personal & home care, mobility, infrastructure, and specialty paper & packaging. A Responsible Care® company, Aurorium follows the highest regulatory standards across all manufacturing facilities. The company's global integrated supply chain offers the customer product consistency, easy access, supply security, and reasonable turnaround on delivery. Aurorium is committed to operating at the highest levels of manufacturing consistency, quality control, and safety.\nDescription\tThe Lead Analyst is responsible for overseeing day-to-day quality control laboratory operations, supporting analytical testing activities, and providing technical support to Lab Analysts. Lead Analyst serves as the technical expert on complex projects and method development. The Lead Analyst is an operational team leader for the laboratory and provides training and mentorship to the team to ensure high-quality data in compliance with global regulatory standards.\n

Job Details Role Specific Responsibilities:

\nPerform analytical and wet chemistry testing in accordance with approved methods and specifications.\nPrioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation and timely batch release.\nLead the setup, daily tuning, and routine operation of specialized analytical equipment such as ICP, AA, GC, HPLC, etc.\nDevelop methods and execute validation protocols in accordance with ICH and USP guidelines.\nPerform complex troubleshooting of instrument hardware and software.\nReview and approve analytical data batches for accuracy, ensuring full adherence to\ndata integrity principles and CGMP.\nOversee the preventive maintenance schedule and calibration programs for laboratory instrumentation to ensure zero downtime.\nOversee the stability testing program and ensure compliance\nManage relationships with external service providers and coordinate equipment installation and trouble shooting.\nMaintain inventory of NIST standards and reagents for calibration.\nDevelop and deliver technical training programs for Lab Analysts on elemental testing, equipment maintenance, and sample preparation techniques.\nServe as the technical lead during internal and external audits (e.g., FDA, ISO, Customer Audits).\nMentor staff on proper laboratory safety and hygiene.\nSupport investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and corrective and preventive actions (CAPAs).\nCollaborate effectively with cross-functional teams including Manufacturing, QA, Supply Chain, Warehouse and EH&S.\n

Compliance:

\nComplies with company Health, Safety and Environmental policies, procedures, and arrangements\nReports all Health, Safety and Environmental accidents, incidents and near misses promptly\nActs in a safe and responsible manner at all times\n

Problem Solving and Innovation:

\nActive participation in continuous improvement activities\nParticipates in problem-solving\nTakes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business\nAssists in the training, mentoring, and assessment of other team members\nExercises autonomy and judgement subject to overall direction or guidance\n

Education and Qualifications:

B.S./M.S.

in Chemistry, Analytical Chemistry, or a related scientific field.\nStrong working knowledge of cGMP regulations and laboratory compliance.\nDemonstrated ability to operate independently or in a team environment.\nExperience\n4-6 years in an analytical laboratory environment with hands-on expertise specifically in ICP-MS, HPLC, GC, AA and wet chemistry testing.\nGood understanding of cGMP and pharmacopeial requirements (USP, EP, JP)\nFamiliarity with stability testing and method validation activities.\n

Knowledge, Skills, and Abilities:

\nStrong communication and interpersonal skills, with the ability to work effectively across teams.\nExcellent attention to detail and strong problem-solving abilities.\nAbility to prioritize tasks and manage multiple responsibilities.\nProficient in laboratory documentation, data review, and electronic systems (e.g., SAP, LIMS).\nCapable of making sound technical decisions and escalating issues appropriately.\nEmbodies the core values of

Aurorium:

credible: keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions outcome-oriented: adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact driven: passionate about delivering authentic, world-class experiences that engage customers and inspire greatness empowered accountability: empowered to achieve common goals and accountable for delivering performances and results that exceed standard.\nIf you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you. today! Aurorium offers competitive total compensation packages, including benefits such as medical, dental, vision, life, 401(k), disability insurance, flexible spending accounts, health savings accounts, paid time off, and paid holidays. Aurorium is a global Equal Opportunity Employer. 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