Lab Analyst - 2nd Shift

Role Specific Responsibilities:

• Prioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation and timely batch release.
• Perform analytical testing using HPLC, GC, and wet chemistry techniques in accordance with approved methods and specifications.
• Review and approve analytical data, laboratory notebooks, and test results to ensure accuracy, completeness, and cGMP compliance.
• Enter results in SAP system
• Provide technical guidance and training to other team members.
• Ensure adherence to cGMP, GLP, and data integrity requirements.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and corrective and preventive actions (CAPAs).
• Assist with method verification/validation, transfer, and troubleshooting of analytical methods and HPLC, GC equipment.
• Participate in internal audits, regulatory inspections, and client audits as needed.
• Collaborate effectively with cross-functional teams including Manufacturing, QA, Supply Chain, Warehouse and EH&S.
• Maintain laboratory equipment, including qualification, calibration, and preventive maintenance activities.
• Contribute to continuous improvement initiatives and support laboratory efficiency and compliance goals.

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 in 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

Knowledge, Skills, and Abilities:

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
• Strong working knowledge of cGMP regulations and laboratory compliance.
• Demonstrated ability to operate independently or in a team environment.
• Minimum of 4 years of experience in a quality control laboratory. 2+ years' experience in a cGMP pharmaceutical organization.
• Hands-on experience with HPLC, GC, and wet chemistry testing.
• Experience supporting regulatory inspections (FDA, Food Safety, ISO, etc.).
• Familiarity with stability testing and method validation activities.
• 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