Lead Analyst
Listed on 2026-08-19
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Company Overview
Aurorium 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.
DescriptionThe 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.
JobDetails Role Specific Responsibilities
- Perform analytical and wet chemistry testing in accordance with approved methods and specifications.
- Prioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation and timely batch release.
- Lead the setup, daily tuning, and routine operation of specialized analytical equipment such as ICP, AA, GC, HPLC, etc.
- Develop methods and execute validation protocols in accordance with ICH and USP guidelines.
- 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 installation and trouble shooting.
- 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.
- 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.
- 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.
- 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.
- 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.
- 4-6 years in an analytical laboratory environment with hands‑on expertise specifically in ICP-MS, HPLC, GC, AA and wet chemistry testing.
- Good understanding of cGMP and pharmacopeial requirements (USP, EP, JP).
- Familiarity with stability testing and method validation activities.
- Strong communication and…
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