Job Details Role Specific Responsibilities:

Lead the setup, daily tuning, and routine operation of ICP-MS and other specialized analytical equipment such as AA, GC, HPLC, etc.\nPerform analytical and wet chemistry testing in accordance with approved methods and specifications.\nDesign and develop robust analytical methods for trace elemental analysis using ICP-MS\nacross various matrices\nAuthor and execute validation protocols in accordance with ICH and USP guidelines.\nEstablish appropriate digestion techniques (e.g., microwave-assisted, open-vessel) and optimize collision/reaction cell parameters (KED/CRI) to mitigate polyatomic interferences.\nPrioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation and timely batch release.\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 qualification activities (IQ/OQ/PQ) for new equipment installations.\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 and the \"trace-metal mindset\" required for ppb/ppt-level analysis.\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.

Compliance:

Complies 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

Problem Solving and Innovation:

Active 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

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.

Experience:

5-8 years in an analytical laboratory environment, with a minimum of 3 yearsof hands-on expertise specifically in ICP-MS, HPLC, GC, AA and wet chemistry testing.\nDeep understanding of cGMP and pharmacopeial requirements (USP, EP, JP) for elemental impurities\nFamiliarity with method development, validation and stability testing activities.

Knowledge, Skills, and Abilities:

Strong 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:

\ncredible:keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions\noutcome-oriented:adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact\ndriven:passionate about delivering authentic, world-class experiences that engage customers and inspire greatness\nempowered accountability:empowered to achieve common goals and accountable for delivering performances and results that exceed standard. If you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you. Apply 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. All qualified applicants will receive consideration for employment regardless of and will not be discriminated against based on gender, sexual orientation, gender identity, race, ethnicity, religion, age, veteran status, disability status, genetic information, or any other protected category.#LI-Onsite 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