Sr. Lab Analyst

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.
• Perform analytical and wet chemistry testing in accordance with approved methods and specifications.
• Design and develop robust analytical methods for trace elemental analysis using ICP-MS
• across various matrices
• Author and execute validation protocols in accordance with ICH and USP guidelines.
• Establish appropriate digestion techniques (e.g., microwave-assisted, open-vessel) and optimize collision/reaction cell parameters (KED/CRI) to mitigate polyatomic interferences.
• Prioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation and timely batch release.
• Perform complex troubleshooting of instrument hardware and software.
• Review and approve analytical data batches for accuracy, ensuring full adherence to
• data integrity principles and CGMP.
• Oversee the preventive maintenance schedule and calibration programs for laboratory instrumentation to ensure zero downtime.
• Oversee the stability testing program and ensure compliance
• Manage relationships with external service providers and coordinate equipment qualification activities (IQ/OQ/PQ) for new equipment installations.
• Maintain inventory of NIST standards and reagents for calibration.
• Develop and deliver technical training programs for Lab Analysts on elemental testing, equipment maintenance, and sample preparation techniques.
• Serve as the technical lead during internal and external audits (e.g., FDA, ISO, Customer Audits).
• Mentor staff on proper laboratory safety and hygiene and the "trace-metal mindset" required for ppb/ppt-level analysis.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and corrective and preventive actions (CAPAs).
• Collaborate 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
• Reports all Health, Safety and Environmental accidents, incidents and near misses promptly
• Acts in a safe and responsible manner at all times

Problem Solving and Innovation:

• Active participation within continuous improvement activities
• Participates in problem solving
• Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business
• Assists in the training, mentoring and assessment of other team members
• Exercises 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.
• Strong working knowledge of cGMP regulations and laboratory compliance.
• Demonstrated 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.
• Deep understanding of cGMP and pharmacopeial requirements (USP, EP, JP) for elemental impurities
• Familiarity 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.
• Excellent attention to detail and strong problem-solving abilities.
• Ability to prioritize tasks and manage multiple responsibilities.
• Proficient in laboratory documentation, data review, and electronic systems (e.g., SAP, LIMS).
• Capable of making sound technical decisions and escalating issues appropriately.
• Embodies 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.

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